[Hiring] Former FDA Experts @Pharmavise Corporation

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This is a remote position. 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. Benefits 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. Company Description 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. Follow us in LinkedIn for more company updates and opportunities. Apply tot his job Apply To this Job