Former FDA Experts

Pharmavise Corporation; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

Pharmavise Corporation is seeking an experienced regulatory expert for a fully remote role in the United States. You will provide expert guidance on FDA regulations across drugs, biologics, and medical devices, and support submissions from INDs to PMAs.

You will collaborate with cross-functional teams to align regulatory strategy and ensure timely, compliant submissions. Ideal candidates have 5+ years at the FDA, strong communication skills, and a proven record of successful regulatory

Qualifications

• Minimum 5 years at the FDA in regulatory role with drug/biologic/medical device focus.
• Deep knowledge of FDA regulations, guidance documents and processes.
• Proven track record preparing/submitting regulatory applications and participating in FDA meetings.

Responsibilities

• Provide expert regulatory guidance on FDA regulations, policies and submissions.
• Review and interpret FDA guidance to ensure compliant submissions.
• Support INDs, BLAs, NDAs, 510(k)s and PMA submissions with strategy.
• Conduct regulatory assessments and risk analysis for submissions.
• Assist in FDA meetings and act as regulatory representative.
• Monitor FDA trends and inform clients of potential impacts.
• Collaborate with regulatory affairs, clinical, quality, and medical affairs.
• Serve as liaison between clients and regulators, handling inquiries.

Skills

FDA regulatory expertise

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in pharmacy, biology, chemistry

Job description

This is a remote position. From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety.

Visit us at We are currently seeking talented and experienced professionals with previous experience at the FDA (Food and Drug Administration) to join our team as Former FDA Experts.

Below is a detailed job description outlining the responsibilities, qualifications, and expectations for this role:

Responsibilities:

• Provide expert regulatory guidance and strategic advice to clients on FDA regulations, policies, and procedures related to drug, biologic, and medical device development and approval.
• Review and interpret FDA guidance documents, regulations, and policies to ensure compliance and facilitate successful regulatory submissions.
• Support clients in preparing and submitting regulatory applications, including INDs, BLAs, NDAs, 510(k)s, and PMA submissions, and provide guidance on regulatory strategy and submission content.
• Conduct regulatory assessments and gap analyses to identify potential issues and risks in regulatory submissions and provide recommendations for resolution.
• Assist clients in preparing for FDA meetings, including pre-IND, pre-IDE, pre-NDA/BLA, and pre-PMA meetings, and participate in meetings as a regulatory representative.
• Monitor regulatory trends, changes, and updates from the FDA and provide insights and recommendations to clients on potential impacts on their products and programs.
• Collaborate with cross-functional teams, including regulatory affairs, clinical development, quality assurance, and medical affairs, to ensure alignment on regulatory strategy and objectives.
• Serve as a liaison between clients and regulatory agencies, including facilitating communications, responding to inquiries, and addressing regulatory challenges and issues.

Qualifications:

• Bachelor's degree in pharmacy, biology, chemistry, or related field; advanced degree preferred.
• Minimum of 5 years of experience working at the FDA in a regulatory role, with expertise in drug, biologic, or medical device regulation.
• Deep understanding of FDA regulations, guidance documents, and regulatory processes related to drug, biologic, and medical device development and approval.
• Proven track record of successful interactions with the FDA, including experience in preparing and submitting regulatory applications and participating in FDA meetings.
• Excellent communication and interpersonal skills, with the ability to effectively convey complex regulatory concepts and requirements to clients and internal stakeholders.
• Strong analytical and problem-solving abilities, with the ability to assess regulatory risks and develop strategies for mitigation.
• Regulatory affairs certification (RAC) or relevant professional certification (e.g., Regulatory Affairs Certification Board) preferred but not required.
• Ability to work independently and collaboratively as part of a multidisciplinary team, with a commitment to delivering high-quality regulatory support and guidance to clients.

Competitive compensation packages are available.

Be part of our network of Subject Matter Experts.

EEO Employer: PharmaviseConsulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.PharmaviseConsulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

When you joinPharmavise, you become part of a team that values Excellence Through Quality.

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