Aevi Genomic Medicine, Inc. is dedicated to translating genetic discoveries into novel therapies. Driven by a commitment to patients, and guided by genomic insights, we strive to help patients navigate through the complexities of their disease. If you are looking for an opportunity to be part of building a fast-paced, collaborative, scientifically-disciplined team, then this is a great time to join Aevi to make a difference in the lives of children and adults with pediatric-onset diseases.
Director, Regulatory Affairs
|Title:||Director, Regulatory Affairs|
|Department:||Research and Development|
The position will be responsible for providing high quality regulatory support throughout the product lifecycle to achieve company goals. The position will be the primary liaison with health authorities for the assigned projects and accountable for the content, format, and timing of assigned submissions and other deliverables. Position may require oversight of consultants and contractors.
- In conjunction with Project Teams, responsible for facilitating rapid and effective clinical trial applications, marketing authorizations, and extensions; or variations for assigned products.
- Supports Aevi Genomics in interactions with the FDA and other global health authorities for assigned projects.
- Provides advice and guidance to Aevi Genomics staff regarding regulatory aspects of drug development. This includes providing regulatory guidance and expertise to project teams in the design and conduct of preclinical studies and clinical trials.
- Defines strategies to achieve consistency with FDA and global health authority regulations and ensure compliance throughout all aspects of regulatory filings and post-approval regulatory activities.
- Supports the development of core labeling (and draft labeling) for registration packages, the negotiation of first approval labeling with regulatory agencies, and labeling revisions throughout product lifecycle. Devises strategies for achievement of product labels that are differentiated from Aevi Genomics’ competitors.
- Keeps management up to date regarding pertinent scientific, regulatory, and political influences relevant to future Aevi Genomics business.
- Maintains an awareness of competitor activities, including review of promotion/advertising/press releases, review of approvals, review of labeling, performs monitoring activities e.g., medical/scientific conventions, development and coordination of filings to regulatory agencies, complaints on competitor activities, product withdrawals from markets, etc.
- Communicates status to Aevi Genomics staff with respect to Aevi Genomics product filings, issues, and approvals.
- Reviews and manages the approval process for all regulatory documents for assigned projects prior to submission.
- Oversees the regulatory activities at CROs, providing document review in order to ensure the quality and scientific integrity of documents submitted to regulatory authorities
- Advanced degree in a scientific discipline (M.S., Ph.D., PharmD) preferred, with at least 10 years of relevant regulatory experience; other degrees will be considered with appropriate experience.
- Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration.
- Diverse experience in development and regulatory activities in support for product registration and maintenance, especially with outside partners/vendors.
- Excellent in communicating regulatory strategy, issues, and risks in written and verbal format
- Experience leading cross functional teams.
- Proven success in communicating to and negotiating with FDA and global health authorities.
- Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process.
- Understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies for drug development and approval.
- Experience utilizing leadership techniques to drive a team through all stages of product development.
- CNS/Psychiatry therapeutics experience
- In Vitro or Companion diagnostic regulatory experience
Aevi Genomic Medicine, Inc. offers its employees a competitive benefits and compensation plan.
Aevi Genomic Medicine, Inc. is an Equal Opportunity Employer.