In this position you will support the Regulatory Compliance Team, in executing Abarca's Regulatory Change Management Process, including analysis of regulatory changes, conducting training, P&P ...
In this position you will support the Regulatory Compliance Team, in executing Abarca's Regulatory Change Management Process, including analysis of regulatory changes, conducting training, P&P ...
In this position you will support the Regulatory Compliance Team, in executing Abarca's Regulatory Change Management Process, including analysis of regulatory changes, conducting training, P&P ...
In this position you will support the Regulatory Compliance Team, in executing Abarca's Regulatory Change Management Process, including analysis of regulatory changes, conducting training, P&P ...
The Senior Manager will partnercrossfunctionallywith Quality, Regulatory Affairs, Operations, R&D, ... Regulatory Compliance & Risk Oversight * Provide subject matterexpertiseon regulatory quality ...
The Senior Manager will partnercrossfunctionallywith Quality, Regulatory Affairs, Operations, R&D, ... Regulatory Compliance & Risk Oversight * Provide subject matterexpertiseon regulatory quality ...
The Senior Manager will partnercrossfunctionallywith Quality, Regulatory Affairs, Operations, R&D, ... Regulatory Compliance & Risk Oversight * Provide subject matterexpertiseon regulatory quality ...
The Senior Manager will partnercrossfunctionallywith Quality, Regulatory Affairs, Operations, R&D, ... Regulatory Compliance & Risk Oversight * Provide subject matterexpertiseon regulatory quality ...
PR · On-site
Maintain a clean and safe environment, adhering to health and safety regulations. * Manages and supports all aspects of inventory control, including purchasing, receiving, and storing company ...
Quick apply
PR · On-site
Maintain a clean and safe environment, adhering to health and safety regulations. * Manages and supports all aspects of inventory control, including purchasing, receiving, and storing company ...
PR · On-site
Automation, Control Systems Integration, Information Technology, System Integration and Regulatory ... Lead and manage manufacturing capital project consisting of both company and non-company ...
Quick apply
PR · On-site
Automation, Control Systems Integration, Information Technology, System Integration and Regulatory ... Lead and manage manufacturing capital project consisting of both company and non-company ...
PR · On-site
Supervise the construction of the building's basic structure, architecture and exterior, ensuring compliance with all relevant codes and regulations. * Manage and oversee the construction of the ...
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PR · On-site
Supervise the construction of the building's basic structure, architecture and exterior, ensuring compliance with all relevant codes and regulations. * Manage and oversee the construction of the ...
PR · On-site
$55K - $73K/yr
Automation, Control Systems Integration, Information Technology, System Integration and Regulatory ... Lead and manage manufacturing capital project consisting of both company and non-company ...
Quick apply
PR · On-site
$55K - $73K/yr
Automation, Control Systems Integration, Information Technology, System Integration and Regulatory ... Lead and manage manufacturing capital project consisting of both company and non-company ...
Comply with all safety procedures OSHA, EPA, DEEP and Department of Labor rules and regulations ... Manage and develop marketing and customer relation responsibilities such as crew events, ensuring ...
Comply with all safety procedures OSHA, EPA, DEEP and Department of Labor rules and regulations ... Manage and develop marketing and customer relation responsibilities such as crew events, ensuring ...
Ops & Administrative Manager
San Juan, PR · On-site
Comply with all safety procedures OSHA, EPA, DEEP and Department of Labor rules and regulations ... Manage and develop marketing and customer relation responsibilities such as crew events, ensuring ...
Ops & Administrative Manager
San Juan, PR · On-site
Comply with all safety procedures OSHA, EPA, DEEP and Department of Labor rules and regulations ... Manage and develop marketing and customer relation responsibilities such as crew events, ensuring ...
Manage end-to-end regulatory reporting activities covering 40 Act and non-40 Act funds in the investment management space (e.g., Form PF, TIC, CPO-PQR, Form 16, Form 13, N-PX, BEA reports), ensuring ...
Manage end-to-end regulatory reporting activities covering 40 Act and non-40 Act funds in the investment management space (e.g., Form PF, TIC, CPO-PQR, Form 16, Form 13, N-PX, BEA reports), ensuring ...
Deputy Project Manager
Guaynabo, PR · On-site
$95K/yr
The Deputy Project Manager supports the oversight and execution of procurement, compliance, grant ... regulatory stakeholders to promote operational efficiency, accountability, and continuous ...
Deputy Project Manager
Guaynabo, PR · On-site
$95K/yr
The Deputy Project Manager supports the oversight and execution of procurement, compliance, grant ... regulatory stakeholders to promote operational efficiency, accountability, and continuous ...
PR · On-site
Ensure compliance with GMP, FDA, and industry regulatory requirements. * Support commissioning ... Manage projects involving automation systems, process control systems, utilities, facility ...
Quick apply
PR · On-site
Ensure compliance with GMP, FDA, and industry regulatory requirements. * Support commissioning ... Manage projects involving automation systems, process control systems, utilities, facility ...
PR · On-site
Ensure compliance with GMP, FDA, and industry regulatory requirements. * Support commissioning ... Manage projects involving automation systems, process control systems, utilities, facility ...
Quick apply
PR · On-site
Ensure compliance with GMP, FDA, and industry regulatory requirements. * Support commissioning ... Manage projects involving automation systems, process control systems, utilities, facility ...
PR · On-site
Ensure compliance with GMP, FDA, and industry regulatory requirements. * Support commissioning ... Manage projects involving automation systems, process control systems, utilities, facility ...
Quick apply
PR · On-site
Ensure compliance with GMP, FDA, and industry regulatory requirements. * Support commissioning ... Manage projects involving automation systems, process control systems, utilities, facility ...
Project Manager | Pharmaceutical | Capex
Arecibo, PR · On-site
$90 - $130/hr
Ensure compliance with GMP, FDA, and industry regulatory requirements. * Support commissioning ... Manage projects involving automation systems, process control systems, utilities, facility ...
Project Manager | Pharmaceutical | Capex
Arecibo, PR · On-site
$90 - $130/hr
Ensure compliance with GMP, FDA, and industry regulatory requirements. * Support commissioning ... Manage projects involving automation systems, process control systems, utilities, facility ...
Plant Manager
Anasco, PR · On-site
SUMMARY The Sr. Director, Plant Manager is responsible for developing and implementing strategies ... S. Food and Drug Administration regulations, ISO 9001, ISO 13485, EU MDR, the Canadian Medical ...
Plant Manager
Anasco, PR · On-site
SUMMARY The Sr. Director, Plant Manager is responsible for developing and implementing strategies ... S. Food and Drug Administration regulations, ISO 9001, ISO 13485, EU MDR, the Canadian Medical ...
Plant Manager
Anasco, PR · On-site
SUMMARY The Sr. Director, Plant Manager is responsible for developing and implementing strategies ... S. Food and Drug Administration regulations, ISO 9001, ISO 13485, EU MDR, the Canadian Medical ...
Plant Manager
Anasco, PR · On-site
SUMMARY The Sr. Director, Plant Manager is responsible for developing and implementing strategies ... S. Food and Drug Administration regulations, ISO 9001, ISO 13485, EU MDR, the Canadian Medical ...
Porfolio Manager
Gurabo, PR · On-site
Oversee and manage the capital projects portfolio , ensuring alignment with organizational strategy and regulatory requirements. * Lead project governance , ensuring consistency across global and ...
Porfolio Manager
Gurabo, PR · On-site
Oversee and manage the capital projects portfolio , ensuring alignment with organizational strategy and regulatory requirements. * Lead project governance , ensuring consistency across global and ...
Program Manager
Guaynabo, PR · On-site
Ensure compliance with applicable federal, Commonwealth, and local regulations, contractual ... Support change management, quality assurance, risk management, and resource planning activities ...
Program Manager
Guaynabo, PR · On-site
Ensure compliance with applicable federal, Commonwealth, and local regulations, contractual ... Support change management, quality assurance, risk management, and resource planning activities ...
Regulatory Manager information
What is a regulatory manager?
A Regulatory Manager is a professional responsible for ensuring that a company complies with all relevant laws, regulations, and guidelines related to its industry. They oversee the preparation and submission of regulatory documents, communicate with regulatory agencies, and keep the organization updated on changes to regulations. Regulatory Managers play a key role in minimizing legal risks and supporting the approval and launch of products or services in various markets. They often work in industries such as pharmaceuticals, medical devices, food and beverages, and chemicals.
What are some common challenges a regulatory manager faces when coordinating compliance across multiple regions?
Regulatory Managers often encounter the challenge of navigating varying and evolving regulatory requirements across different regions or countries. This requires staying up to date with local laws, understanding cultural and business practice differences, and ensuring consistent compliance strategies company-wide. Effective coordination involves frequent communication with cross-functional teams, such as legal, quality assurance, and operations, to align on regulatory expectations and swiftly address compliance gaps. Successfully managing these challenges enhances the organization's ability to enter new markets and maintain product approvals.
What are the key skills and qualifications needed to thrive as a regulatory manager, and why are they important?
To thrive as a Regulatory Manager, you need strong analytical skills, a deep understanding of regulations in your industry, and typically a bachelor's or advanced degree in a relevant field. Familiarity with regulatory submission systems, compliance management software, and certifications such as RAC (Regulatory Affairs Certification) are often required. Excellent organizational, communication, and negotiation skills help build relationships with regulatory bodies and ensure team alignment. These competencies are crucial for ensuring products or services meet legal requirements, minimizing risk, and maintaining organizational reputation.
What is the difference between Regulatory Manager vs Regulatory Affairs Specialist?
| Aspect | Regulatory Manager | Regulatory Affairs Specialist |
|---|---|---|
| Required Credentials | Bachelor's degree in life sciences, regulatory affairs certification often preferred | Bachelor's degree in life sciences, regulatory affairs certification beneficial |
| Work Environment | Oversees regulatory teams, manages compliance strategies, interacts with regulatory agencies | Supports regulatory submissions, prepares documentation, conducts research |
| Employer & Industry Usage | Pharmaceutical, biotech, medical device companies | Pharmaceutical, biotech, medical device companies |
| Search & Comparison Intent | Understanding managerial roles, career progression | Entry-level to mid-level regulatory roles, daily responsibilities |
The Regulatory Manager typically oversees regulatory teams and strategies, requiring leadership skills and experience, while the Regulatory Affairs Specialist focuses on preparing documentation and supporting compliance tasks. Both roles are essential in regulated industries like pharma and biotech, but they differ in scope and responsibilities.
What are the most commonly searched types of Regulatory jobs in Puerto Rico?
The most popular types of Regulatory jobs in Puerto Rico are:
What are popular job titles related to Regulatory Manager jobs in Puerto Rico?
For Regulatory Manager jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Regulatory Manager jobs in Puerto Rico look for?
The top searched job categories for Regulatory Manager jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Regulatory Manager jobs?
Cities in Puerto Rico with the most Regulatory Manager job openings:
Job description
What you'll do
In a few words...
Abarca is igniting a revolution in healthcare. We built our company on the belief that with smarter technology we are redefining pharmacy benefits, but this is just the beginning...
As our Senior Regulatory Compliance Analyst you will be responsible for ensuring that business operations and procedures are compliant with all state and federal regulatory requirements, including HIPAA requirements, as applicable to Abarca. You will ensure that business owners receive, understand, and implement most recent federal and state regulations. You will be an independent and critical thinker, and an effective communicator. It is important that you are always up to speed on all regulations applicable to Abarca operations and delegated services!
In this position you will support the Regulatory Compliance Team, in executing Abarca's Regulatory Change Management Process, including analysis of regulatory changes, conducting training, P&P's management, and regulatory consults. You will perform a range of duties such as identifying and evaluating compliance regulations and guidance, supporting operational areas in the identification of operational impact, overseeing the implementation and documentation of new requirements, and researching and responding to regulatory consults. Also, you'll be responsible for acting as a consultative figure to our clients on regulatory topics, addressing possible changes to delegated services and regulatory questions stemming from potential audit concerns.
The fundamentals for the job...
What we expect of you
The bold requirements...
Nice to haves...
Physical requirements...
At Abarca we value and celebrate diversity. Diversity, equity, inclusion, and belonging are guiding principles of Abarca and ensure Abarca's workforce reflects the communities it serves. We are proud to provide equal employment opportunities to all employees and applicants for employment and prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, medical condition, genetic information, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Abarca Health LLC is an equal employment opportunity employer and participates in E-Verify. "Abarca Health LLC does not sponsor employment visas at this time"
The above description is not intended to limit the scope of the job or to exclude other duties not mentioned. It is not a final set of specifications for the position. It's simply meant to give readers an idea of what the role entails.
In a few words...
Abarca is igniting a revolution in healthcare. We built our company on the belief that with smarter technology we are redefining pharmacy benefits, but this is just the beginning...
As our Senior Regulatory Compliance Analyst you will be responsible for ensuring that business operations and procedures are compliant with all state and federal regulatory requirements, including HIPAA requirements, as applicable to Abarca. You will ensure that business owners receive, understand, and implement most recent federal and state regulations. You will be an independent and critical thinker, and an effective communicator. It is important that you are always up to speed on all regulations applicable to Abarca operations and delegated services!
In this position you will support the Regulatory Compliance Team, in executing Abarca's Regulatory Change Management Process, including analysis of regulatory changes, conducting training, P&P's management, and regulatory consults. You will perform a range of duties such as identifying and evaluating compliance regulations and guidance, supporting operational areas in the identification of operational impact, overseeing the implementation and documentation of new requirements, and researching and responding to regulatory consults. Also, you'll be responsible for acting as a consultative figure to our clients on regulatory topics, addressing possible changes to delegated services and regulatory questions stemming from potential audit concerns.
The fundamentals for the job...
- Keep up to speed with all regulatory requirements and legislation, industry trends, and best practices applicable to Abarca and delegated functions.
- Continuously monitor, analyze, and assess changes in regulatory requirements, legislation, and industry trends for Commercial and Government lines of business, as well as HIPAA regulations.
- Track regulatory changes, maintain an updated regulatory log, and prepare compliance updates and summaries for internal and external stakeholders.
- Collaborate with business areas to discuss new or updated regulations and identify regulatory impact to operations or systems.
- Oversee timely implementation and documentation of regulatory changes verifying that all requirements are properly addressed, providing guidance to regulatory questions, and ensuring thorough testing and quality assurance is conducted prior to go-live.
- Participate in the Regulatory Change Management (RCM) Committee meetings, present regulatory updates and engage subject matter experts (SME's).
- Provide research and timely responses to regulatory questions from clients and internal business areas.
- Develop, update, and deliver regulatory compliance training materials and ensure all employees and delegated entities receive required training.
- Create, review, and update policies and procedures (P&Ps) to ensure compliance with state and federal regulations, contractual obligations and business operations.
- Facilitate communication and collaboration between the Compliance department and internal business units to align business processes with regulatory requirements.
- Support with privacy and security investigations as well as risk assessment process and collaborate with the Information Security Team for system security issues related to compliance. Ensure adherence to HIPAA requirements and Business Associate Agreements.
What we expect of you
The bold requirements...
- Bachelor, Law Degree, or masters degree in Health Services Administration, Public Health, Health Evaluation, or related field. (In lieu of a degree, equivalent, relevant work experience may be considered.)
- 6+ years of experience in Healthcare Compliance or healthcare regulatory management role.
- 3+ experience in Medicare and other government programs.
- Experience in PBM operations and/or health plan pharmacy operations.
- Experience collaborating with internal and external stakeholders.
- Experience with analysis, strategic thinking and planning skills within regulatory context.
- Excellent oral and written communication skills.
- We are proud to offer a flexible hybrid work model which will require certain on-site workdays (Puerto Rico Location Only)
- This position requires availability to work in a specified time zone or working schedule, accommodating the business needs of our clients and team members.
Nice to haves...
- Certified in Healthcare Compliance (CHC), Certified Fraud Examiner (CFE), or Certified Internal Auditor (CIA).
Physical requirements...
- Must be able to access and navigate each department at the organization's facilities.
- Sedentary work that primarily involves sitting/standing.
At Abarca we value and celebrate diversity. Diversity, equity, inclusion, and belonging are guiding principles of Abarca and ensure Abarca's workforce reflects the communities it serves. We are proud to provide equal employment opportunities to all employees and applicants for employment and prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, medical condition, genetic information, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Abarca Health LLC is an equal employment opportunity employer and participates in E-Verify. "Abarca Health LLC does not sponsor employment visas at this time"
The above description is not intended to limit the scope of the job or to exclude other duties not mentioned. It is not a final set of specifications for the position. It's simply meant to give readers an idea of what the role entails.
About Abarca Health
Sourced by ZipRecruiter
Company size
201 - 500 Employees
Headquarters location
Miami, FL, US
Year founded
2006