Former FDA Experts

Pharmavise Corporation; Remote; USD 60,000 - 80,000; Full time

Job summary

A regulatory compliance consulting firm is seeking a Regulatory Expert to provide guidance on FDA regulations related to drug and device approval. You will leverage your expertise to assist clients in navigating compliance and regulatory submissions, as well as monitor regulatory trends. The ideal candidate will possess a relevant degree and at least 5 years of experience at the FDA. This role can be performed remotely and offers competitive compensation.

Benefits

Competitive compensation packages

Flexible work arrangement

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.
• Deep understanding of FDA regulations and regulatory processes.

Responsibilities

• Provide expert regulatory guidance and advice to clients.
• Review FDA regulations and support regulatory submissions.
• Conduct regulatory assessments to identify potential issues.

Skills

Regulatory guidance

Analytical skills

Communication skills

Education

Bachelor's degree in pharmacy, biology, chemistry, or related field

Regulatory affairs certification (RAC)

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 www.pharmavise.com

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.

This is a unique opportunity for former FDA professionals to leverage their regulatory expertise and make a meaningful impact in the pharmaceutical and medical device industries. Competitive compensation packages are available.

Be part of our network of Subject Matter Experts.

EEO Employer

Pharmavise Consulting 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. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact [e-mail].

Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.

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