Regulatory Compliance Expert

5 days ago

Maple Grove, Minnesota, United States Pharmavise Corporation Full time

We are seeking an experienced Regulatory Compliance Expert to join our team at Pharmavise Consulting Corp. in a remote position. As a Former FDA Experts, you will leverage your regulatory expertise to provide guidance and strategic advice to clients on FDA regulations, policies, and procedures related to drug, biologic, and medical device development and approval.

Key Responsibilities:

  • Provide expert regulatory guidance and strategic advice to clients on FDA regulations, policies, and procedures.
  • 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.
  • 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.

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.

This is a competitive compensation package position, estimated at $120,000 - $180,000 per year, depending on qualifications and experience. Our company values Excellence Through Quality and is committed to delivering high-quality regulatory support and guidance to clients. We are an EEO Employer and do not discriminate based on race, color, religion, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

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