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Manager Of Regulatory Affairs Jobs in Puerto Rico

Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product ... Grade is commensurate on level of overall responsibility. Responsibilities: * Performs final ...

New

Engineering Program Manager

Villalba, PR · On-site

$125K/yr

Coordinatecrossfunctionalteams including Engineering, Quality, Regulatory Affairs, Manufacturing ... Minimum of 7-10 years of progressive experience in engineering, program management, orproject ...

Engineering Program Manager

Villalba, PR · On-site

$125K/yr

Coordinate cross-functional teams including Engineering, Quality, Regulatory Affairs, Manufacturing ... Minimum of 7-10 years of progressive experience in engineering, program management, or project ...

PR · On-site

Project Manager PharmEng Technology has been providing quality services to leading manufacturers of ... Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on ...

PR · On-site

... Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with ... senior management as needed. * Maintain up-to-date knowledge of relevant laws, regulations, and ...

PR · On-site

... Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on ... of meetings with team members and hourly associates * Using tooling to manage gauge design and ...

PR · On-site

$72.10K - $92.80K/yr

... Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on ... You need to have a good knowledge of tool design and fabrication methods. Other necessary ...

PR · On-site

... Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on ... of meetings with team members and hourly associates * Using tooling to manage gauge design and ...

PR · On-site

... Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on ... of meetings with team members and hourly associates * Using tooling to manage gauge design and ...

PR · On-site

$65.20K - $83.90K/yr

... Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on ... You need to have a good knowledge of tool design and fabrication methods. Other necessary ...

PR · On-site

Collaborate cross-functionally with Process Development, Manufacturing, Quality, Regulatory Affairs ... management of US FDA, EMA, Health Canada, and other global regulatory inspections . * Strong ...

PR · On-site

... Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with ... Strong working knowledge of pharmaceutical industry regulations (GMP, GDP, ICH, etc.) * Strong ...

This position reports to the Sr Manager, QARA Global Strategic Accounts - Americas and is part of the Quality & Regulatory Affairs Multifunction General located in Cytiva Westborough, MA; Duncan, SC;

... Quality, Regulatory Affairs, Value Chain Management, and Supply Chain. * Champion CM capability ... Provide technical guidance of postlaunch performance to enable commercial improvements Background ...

This position reports to the QA Compliance Manager and is part of the Quality Assurance Department ... Regulatory Affairs knowledge and experience. * Computer oriented, knowledge in Enterprise Resource ...

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Showing results 1-20

Manager Of Regulatory Affairs information

What are the key skills and qualifications needed to thrive as a Manager of Regulatory Affairs, and why are they important?

To thrive as a Manager of Regulatory Affairs, you need a solid understanding of regulatory guidelines, compliance processes, and industry standards, typically supported by a relevant science degree and experience in regulatory affairs. Familiarity with regulatory submission systems, document management tools, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Strong leadership, attention to detail, and effective communication skills help navigate complex regulations and lead cross-functional teams. These skills are crucial for ensuring products meet legal requirements and reach the market efficiently while minimizing compliance risks.

What are some common challenges faced by a Manager of Regulatory Affairs when working with cross-functional teams?

A Manager of Regulatory Affairs often faces challenges in aligning regulatory requirements with the objectives of departments like R&D, marketing, and manufacturing. Balancing compliance while supporting innovation and business timelines requires strong communication and negotiation skills. Additionally, interpreting evolving regulatory guidelines and ensuring all stakeholders are informed can be complex, especially in global operations. Successful managers build strong relationships across teams and proactively address potential compliance issues early in the development process.

What does a Manager of Regulatory Affairs do?

A Manager of Regulatory Affairs oversees the process of ensuring that a company complies with all regulations and laws relevant to its business. This professional leads the preparation and submission of documents and applications to regulatory agencies, manages communication with regulatory bodies, and monitors changes in regulations that could affect the company’s products or processes. They also develop strategies to obtain and maintain product approvals, and often collaborate with other departments like research, development, and quality assurance. Their work is crucial for companies in industries such as pharmaceuticals, biotechnology, medical devices, and food to ensure products are safe, effective, and legally marketed.
What are the most commonly searched types of Of Regulatory Affairs jobs in Puerto Rico? The most popular types of Of Regulatory Affairs jobs in Puerto Rico are:
What job categories do people searching Manager Of Regulatory Affairs jobs in Puerto Rico look for? The top searched job categories for Manager Of Regulatory Affairs jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Manager Of Regulatory Affairs jobs? Cities in Puerto Rico with the most Manager Of Regulatory Affairs job openings:

Senior Manager, Corporate Affairs

Bristol-Myers Squibb Company

Guaynabo, PR • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 10 days ago


Job description

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Senior Manager, Corporate Affairs
Division/Department: Global Corporate Affairs
Job Description Summary
The Senior Manager, Corporate Affairs, will provide support for Puerto Rico (50%) & other commercial communications needs for the region (50%). He/She is responsible for designing and executing communications and corporate engagement strategies that will help support BMS growth and priorities in Puerto Rico and across the region. He/she is a seasoned Corporate Affairs leader, with strong strategic and operational ability to support the function.
The Senior Manager, Corporate Affairs reports to the Associate Director of Communications for LATAM and will work closely with the General Manager for Puerto Rico and other functions across the LATAM regions. This position is headquartered in Puerto Rico and requires some international travel within LATAM.
Main responsibilities:
The role requires a professional who is knowledgeable about the healthcare field in Puerto Rico. The role incorporates accountability and responsibility for the direction and successful operational delivery of internal and external communications programs in support of our corporate brand in Puerto Rico and in support of our commercialization portfolio across other LATAM countries.
PUERTO RICO:
  • Market Communications
    • Aligns strategy to overall objectives of BMS Puerto Rico, in continuous cooperation with different functions, and in alignment with the GM
    • Proactively drives initiatives that contribute to building a strong reputation for BMS aligned with global and regional objectives.
    • Prepares for stakeholder reactions to corporate, brand and regulatory milestones, and delivers appropriate communications strategies to maximize communications opportunities while mitigating risks. Anticipates and handles issues, leading communication efforts to mitigate impact on BMS reputation.
    • Partners with HR in the delivery of the people experience engagement and change initiatives as needed. Provides strategic direction to the people experience communications for BMS Puerto Rico and ensures the roll out of strategic engagement programs across the market.

Commercial Communications:
  • Brand communications & reputation management
    • Works with the Associate Director of LATAM Corporate Affairs and local CA leads to develop and execute communications strategies - on demand - for specific markets including media relations, brand and digital communications in support of the product portfolio and business objectives.
      • Considers appropriate multi-channel approach for product communication campaigns, leveraging data and analytics to inform and deploy plans on media, social and digital platforms.
      • Assists in the development and execution of integrated communications strategy, including the editorial content strategy, public relations, brand messaging to support product visibility and growth across the region.
    • Manages day-to-day interactions with external agencies to ensure high-quality deliverables that meet timelines and align with BMS policies.

Education, Qualifications and Skills:
  • 5-7+ years of related experience in positions of responsibility. Pharmaceutical sector experience desirable but not mandatory.
  • Degree in Communications or related disciplines.
  • Proven track record of delivering high impact campaigns which support business objectives
  • Strategic thinking
  • Ability to work under pressure in a fast-changing environment
  • Commitment to a highly ethical organization
  • Experience in working for large global organization, and strong ability to collaborate across the matrix with access, regulatory, medical and legal teams across the world.
  • Excellent ability to partner with business stakeholders, experience in working with senior executives and being part of the leadership team
  • Fluent in Spanish and English

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
Guaynabo - PR - US: $105,850 - $128,266
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
  • Health Coverage: Medical, pharmacy, dental, and vision care.
  • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
  • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life benefits include:
Paid Time Off
  • US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
  • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1599848 : Senior Manager, Corporate Affairs