Former FDA experience is welcome but not required. Key Responsibilities FDA CVM Regulatory Strategy & Engagement * Assess and confirm the appropriate product classification and U.S. regulatory ...
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Former FDA experience is welcome but not required. Key Responsibilities FDA CVM Regulatory Strategy & Engagement * Assess and confirm the appropriate product classification and U.S. regulatory ...
The consultant will evaluate current operations against applicable FDA regulatory requirements, current Good Manufacturing Practice (cGMP) regulations, and relevant industry standards using a ...
New
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The consultant will evaluate current operations against applicable FDA regulatory requirements, current Good Manufacturing Practice (cGMP) regulations, and relevant industry standards using a ...
New
Review NDA content for completeness, consistency, compliance risks, and FDA readiness. * Identify regulatory gaps and recommend appropriate actions to address issues prior to submission. * Work ...
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Review NDA content for completeness, consistency, compliance risks, and FDA readiness. * Identify regulatory gaps and recommend appropriate actions to address issues prior to submission. * Work ...
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Company Description 360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud ...
Company Description 360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud ...
$163K - $216K/yr
The Director is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made ...
$163K - $216K/yr
The Director is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made ...
Director, US Regulatory Advertising & Promotion (Remote)
Cambridge, MA · Remote
$163K - $216K/yr
The Director is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made ...
Director, US Regulatory Advertising & Promotion (Remote)
Cambridge, MA · Remote
$163K - $216K/yr
The Director is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made ...
This individual will represent Amylyx with FDA's Office of Prescription Drug Promotion (OPDP) and play a critical leadership role supporting the successful launch of avexitide and future commercial ...
This individual will represent Amylyx with FDA's Office of Prescription Drug Promotion (OPDP) and play a critical leadership role supporting the successful launch of avexitide and future commercial ...
Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing ...
Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing ...
Director, Regulatory Advertising & Promotion
Burlington, MA · On-site
$185 - $240/hr
Oversee timely and accurate submission of promotional materials to FDA, including Form FDA 2253 submissions and FDA Office of Prescription Drug Promotion (OPDP) advisory comment requests, as ...
Director, Regulatory Advertising & Promotion
Burlington, MA · On-site
$185 - $240/hr
Oversee timely and accurate submission of promotional materials to FDA, including Form FDA 2253 submissions and FDA Office of Prescription Drug Promotion (OPDP) advisory comment requests, as ...
Director, Regulatory Advertising & Promotion
Burlington, MA · On-site
$184K - $239K/yr
Oversee timely and accurate submission of promotional materials to FDA, including Form FDA 2253 submissions and FDA Office of Prescription Drug Promotion (OPDP) advisory comment requests, as ...
Director, Regulatory Advertising & Promotion
Burlington, MA · On-site
$184K - $239K/yr
Oversee timely and accurate submission of promotional materials to FDA, including Form FDA 2253 submissions and FDA Office of Prescription Drug Promotion (OPDP) advisory comment requests, as ...
Support the execution of certification activities and risk analysis for multiple new product development projects, including FDA-regulated medical devices and products subject to EU MDR 2017/745 ...
Support the execution of certification activities and risk analysis for multiple new product development projects, including FDA-regulated medical devices and products subject to EU MDR 2017/745 ...
Director, Regulatory Advertising & Promotion
Burlington, MA · On-site
$184K - $239K/yr
Oversee timely and accurate submission of promotional materials to FDA, including Form FDA 2253 submissions and FDA Office of Prescription Drug Promotion (OPDP) advisory comment requests, as ...
Quick apply
Director, Regulatory Advertising & Promotion
Burlington, MA · On-site
$184K - $239K/yr
Oversee timely and accurate submission of promotional materials to FDA, including Form FDA 2253 submissions and FDA Office of Prescription Drug Promotion (OPDP) advisory comment requests, as ...
Support the preparation of regulatory filings including FDA 510(k) submissions and Technical Files/Design Dossiers, and maintain Design History Files (DHF) in compliance with 21 CFR Part 820 Design ...
Support the preparation of regulatory filings including FDA 510(k) submissions and Technical Files/Design Dossiers, and maintain Design History Files (DHF) in compliance with 21 CFR Part 820 Design ...
Senior Director, Regulatory Strategy & Policy
Boston, MA · On-site
$240 - $320/hr
S. FDA Regulatory Affairs strategic partner to the Global Heads of Regulatory Strategy (Therapeutic Dermatology, DS and IA), providing strategic leadership on FDA engagement, regulatory submissions ...
Senior Director, Regulatory Strategy & Policy
Boston, MA · On-site
$240 - $320/hr
S. FDA Regulatory Affairs strategic partner to the Global Heads of Regulatory Strategy (Therapeutic Dermatology, DS and IA), providing strategic leadership on FDA engagement, regulatory submissions ...
$86K - $113K/yr
Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good ...
$86K - $113K/yr
Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good ...
Associate Director, Global Regulatory Affairs - Ad / Promo
Cambridge, MA · On-site
$146K - $234K/yr
You'll lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB), ensuring alignment with regulatory requirements while ...
Associate Director, Global Regulatory Affairs - Ad / Promo
Cambridge, MA · On-site
$146K - $234K/yr
You'll lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB), ensuring alignment with regulatory requirements while ...
QA Compliance Manager
Fall River, MA · On-site
$86K - $113K/yr
Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good ...
QA Compliance Manager
Fall River, MA · On-site
$86K - $113K/yr
Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good ...
QA Compliance Manager
$86K - $113K/yr
Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good ...
QA Compliance Manager
$86K - $113K/yr
Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good ...
Associate Director, Global Regulatory Affairs - Ad / Promo
Cambridge, MA · On-site
$168K - $268K/yr
You'll lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB), ensuring alignment with regulatory requirements while ...
Associate Director, Global Regulatory Affairs - Ad / Promo
Cambridge, MA · On-site
$168K - $268K/yr
You'll lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB), ensuring alignment with regulatory requirements while ...
This individual will represent Amylyx with FDA's Office of Prescription Drug Promotion (OPDP) and play a critical leadership role supporting the successful launch of avexitide and future commercial ...
This individual will represent Amylyx with FDA's Office of Prescription Drug Promotion (OPDP) and play a critical leadership role supporting the successful launch of avexitide and future commercial ...
Fda information
What does an FDA professional do?
An FDA professional works for the U.S. Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, medical devices, food, cosmetics, and other products. Their roles can include reviewing and approving new drugs and medical devices, conducting inspections, enforcing regulations, and providing guidance to industries. FDA professionals may also work in research, policy development, and public outreach to ensure that products meet regulatory standards and are safe for consumer use.
What are the key skills and qualifications needed to thrive as an FDA Regulatory Affairs Specialist, and why are they important?
To thrive as an FDA Regulatory Affairs Specialist, you need a strong background in life sciences, regulatory guidelines, and compliance, usually supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, FDA regulations (such as 21 CFR), and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills help professionals navigate complex regulations and collaborate with cross-functional teams. These competencies ensure that products meet legal requirements and safety standards, facilitating successful approvals and market access.
What are some typical challenges faced by professionals working at the FDA, and how can they be managed?
Professionals at the FDA often navigate complex regulatory requirements, tight deadlines, and the need to balance public health priorities with industry innovation. Collaborating across multidisciplinary teams and staying updated on evolving scientific data are essential parts of the role. Adapting to frequent changes in policy and handling high volumes of submissions can be demanding, but leveraging strong communication skills and seeking mentorship within the agency can help manage these challenges effectively.
What is the difference between Fda vs Food Scientist?
| Aspect | Fda | Food Scientist |
|---|---|---|
| Required Credentials | Typically a degree in health, science, or related field; certifications vary | Bachelor's or master's in food science, microbiology, or related |
| Work Environment | Regulatory agencies, laboratories, inspection sites | Food manufacturing facilities, laboratories, research settings |
| Employer & Industry Usage | U.S. Food and Drug Administration, government agencies | Food companies, research institutions, government agencies |
| Common Search & Comparison Intent | Understanding regulatory roles, compliance, and enforcement | Food safety, product development, research |
While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.
What qualifications do you need to work for the Food and Drug Administration?
To work for the Food and Drug Administration (FDA), candidates typically need a bachelor's degree in a relevant field such as science, engineering, or public health. For certain positions, advanced degrees or specialized certifications may be required, along with relevant work experience and knowledge of regulatory processes and compliance standards.
What are the most commonly searched types of Fda jobs in Massachusetts?
The most popular types of Fda jobs in Massachusetts are:
What are popular job titles related to Fda jobs in Massachusetts?
For Fda jobs in Massachusetts, the most frequently searched job titles are:
What job categories do people searching Fda jobs in Massachusetts look for?
The top searched job categories for Fda jobs in Massachusetts are:
What cities in Massachusetts are hiring for Fda jobs?
Cities in Massachusetts with the most Fda job openings:
Veterinary Biologics Regulatory & Development Strategy Consultant
Boston, MA • On-site, Remote
Full-time
Posted 6 days ago
Job description
Veterinary Biologics Regulatory & Development Strategy Consultant
Location: Remote
Engagement Type: Consulting / Contract
Start: As soon as possible
Target Completion: By the end of 2026
Position Overview
We are seeking an experienced Veterinary Regulatory & Development Strategy Consultant to support an early-stage development program for a novel feline biologic therapeutic.
The consultant will help establish an integrated U.S. regulatory and development strategy, with particular emphasis on FDA Center for Veterinary Medicine (CVM) requirements, development planning, regulatory interactions, and the use of international CROs and foreign-generated study data.
The ideal consultant will have significant experience with veterinary drug and/or biologics development and navigating FDA CVM regulatory pathways. Former FDA experience is welcome but not required.
Key Responsibilities
FDA CVM Regulatory Strategy & Engagement
Assess and confirm the appropriate product classification and U.S. regulatory pathway.
Determine the appropriate regulatory authority and pathway, including FDA CVM or USDA, if applicable.
Provide strategic guidance for establishing an Investigational New Animal Drug (INAD) file.
Develop a phased regulatory strategy progressing toward a New Animal Drug Application (NADA).
Advise on the timing, content, and strategy for regulatory agency interactions.
Assess potential eligibility for conditional or expanded conditional approval and recommend an appropriate regulatory strategy.
Veterinary Development Strategy
Review and refine the existing development package for an early-stage feline therapeutic program.
Evaluate the proposed preclinical/nonclinical and clinical development sequence.
Confirm that planned studies are appropriately designed to support future regulatory submissions.
Identify scientific, regulatory, or development gaps that could impact advancement of the program.
Review the proposed in vivo feline study strategy and assess whether the design, endpoints, and resulting data will adequately support future submissions.
Recommend additional studies or development activities where appropriate.
Develop an integrated roadmap connecting early development activities with future regulatory milestones.
International CRO & Foreign Study Data Strategy
Advise on the use of international CROs for development activities.
Assess which development activities may appropriately be conducted outside the United States, including protein production, assay development, PK/PD, safety, and clinical studies.
Provide guidance regarding applicable GLP, GCP, data integrity, documentation, and regulatory requirements for foreign-generated data.
Evaluate the acceptability of foreign study data for future FDA submissions.
Determine whether U.S. bridging or confirmatory studies may be advisable or required.
Recommend strategies for CRO qualification, oversight, documentation, and study execution to maximize regulatory acceptance of resulting data.
CRO Partnership & Development Considerations
Provide strategic input regarding development and cost-sharing arrangements with external CRO partners.
Advise on regulatory-development considerations associated with maintaining appropriate ownership and control of product-related intellectual property, regulatory data, and commercialization rights.
Identify areas where specialized intellectual property or transactional legal counsel should be incorporated into the partnership strategy.
Consultant Qualifications
Significant experience with FDA CVM regulatory strategy and veterinary drug development.
Demonstrated knowledge of INAD and NADA regulatory pathways.
Experience developing regulatory strategies for early-stage animal health products.
Experience with biologics, recombinant proteins, or other complex veterinary therapeutics strongly preferred.
Understanding of conditional and expanded conditional approval pathways for animal drugs.
Ability to critically review preclinical and clinical development plans and identify regulatory or development gaps.
Knowledge of GLP, GCP, data integrity, and regulatory requirements for foreign-generated study data.
Experience working with international CROs and/or development programs involving studies conducted outside the United States.
Ability to advise on FDA interactions, regulatory submissions, and overall development sequencing.
Experience with feline therapeutics or clinical studies involving cats is highly desirable.
Former FDA/CVM experience is a plus but not required.
Engagement Expectations
This is a strategic, remote consulting engagement supporting an early-stage veterinary biologics development program.
The selected consultant will work closely with the development team to establish a practical regulatory roadmap, refine the existing development plan, identify critical gaps, and ensure planned domestic and international development activities are positioned to support future FDA submissions.
Immediate availability is preferred, with the engagement targeted for completion by the end of 2026.
About FDA Group
Sourced by ZipRecruiter
Industry
Recruiting and staffing services
Company size
11 - 50 Employees
Headquarters location
Westborough, MA, US
Year founded
2007