Regulatory Expertise for Pharmaceutical and Medical Device Industries

2 days ago

Maple Grove, Minnesota, United States Pharmavise Corporation Full time
Job Description

Pharmavise Consulting Corp. is seeking experienced professionals with a background in regulatory affairs to join our team as Former FDA Experts. This is a unique opportunity to leverage your expertise and make a meaningful impact in the pharmaceutical and medical device industries.

Responsibilities:
  1. Regulatory Guidance and Strategy: 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.
  2. Regulatory Document Review and Interpretation: Review and interpret FDA guidance documents, regulations, and policies to ensure compliance and facilitate successful regulatory submissions.
  3. Regulatory Application Support: 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.
  4. Regulatory Assessments and Gap Analysis: Conduct regulatory assessments and gap analyses to identify potential issues and risks in regulatory submissions and provide recommendations for resolution.
  5. Regulatory Meetings and Communications: 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.
  6. Regulatory Trend Monitoring: Monitor regulatory trends, changes, and updates from the FDA and provide insights and recommendations to clients on potential impacts on their products and programs.
  7. Collaboration and Liaison: Collaborate with cross-functional teams, including regulatory affairs, clinical development, quality assurance, and medical affairs, to ensure alignment on regulatory strategy and objectives.
  8. Client and Regulatory Agency Liaison: Serve as a liaison between clients and regulatory agencies, including facilitating communications, responding to inquiries, and addressing regulatory challenges and issues.
Qualifications:
  1. Education: Bachelor's degree in pharmacy, biology, chemistry, or related field; advanced degree preferred.
  2. Experience: Minimum of 5 years of experience working at the FDA in a regulatory role, with expertise in drug, biologic, or medical device regulation.
  3. Regulatory Knowledge: Deep understanding of FDA regulations, guidance documents, and regulatory processes related to drug, biologic, and medical device development and approval.
  4. Track Record: Proven track record of successful interactions with the FDA, including experience in preparing and submitting regulatory applications and participating in FDA meetings.
  5. Communication and Interpersonal Skills: Excellent communication and interpersonal skills, with the ability to effectively convey complex regulatory concepts and requirements to clients and internal stakeholders.
  6. Analytical and Problem-Solving Abilities: Strong analytical and problem-solving abilities, with the ability to assess regulatory risks and develop strategies for mitigation.
  7. Regulatory Certification: Regulatory affairs certification (RAC) or relevant professional certification (e.g., Regulatory Affairs Certification Board) preferred but not required.
  8. Teamwork and Commitment: 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.

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