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Fda Jobs in Walpole, MA (NOW HIRING)

Cipla

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 ...

Cipla

QA Compliance Manager

Fall River, MA

$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 ...

Sobi

US Regulatory Strategy lead

Waltham, MA

Leads triage process for any FDA Information Requests or Health Authority Communications that require Sponsor Response to FDA * Contributes to Submission Taskforce meeting and efforts to ensure ...

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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?

AspectFdaFood Scientist
Required CredentialsTypically a degree in health, science, or related field; certifications varyBachelor's or master's in food science, microbiology, or related
Work EnvironmentRegulatory agencies, laboratories, inspection sitesFood manufacturing facilities, laboratories, research settings
Employer & Industry UsageU.S. Food and Drug Administration, government agenciesFood companies, research institutions, government agencies
Common Search & Comparison IntentUnderstanding regulatory roles, compliance, and enforcementFood 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 cities near Walpole, MA are hiring for Fda jobs?

Cities near Walpole, MA with the most Fda job openings:

Fda jobs near you
Infographic showing various Fda job openings in Walpole, MA as of August 2026, with employment types broken down into 78% Full Time, 11% Part Time, and 11% Contract. Highlights an 94% In-person, and 6% Remote job distribution.

Veterinary Biologics Regulatory & Development Strategy Consultant

The FDA Group

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.