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Regulatory Expert

2 months ago

Maple Grove, Minnesota, United States Pharmavise Corporation Full time
Regulatory Expert Opportunity

We are seeking a highly skilled Regulatory Expert to join our team at Pharmavise Consulting Corp. As a Regulatory Expert, you will 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.

Responsibilities:
  • Provide regulatory expertise 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.
  • Assist clients in preparing for FDA meetings, including pre-IND, pre-IDE, pre-NDA/BLA, and pre-PMA meetings.
  • Monitor regulatory trends, changes, and updates from the FDA and provide insights and recommendations to clients.
  • Collaborate with cross-functional teams to ensure alignment on regulatory strategy and objectives.
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.

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.

Pharmavise Consulting Corp. is an equal opportunity employer and values diversity in the workplace. We do not discriminate on the basis of race, color, religion, creed, sex, 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.