We are seeking a well experienced Regulatory Affairs professional able to develop and oversee regulatory strategy supporting the approval of new drug and biologic products in a wide range of therapeutic areas and applications. This Associate Director level role will report directly to the Senior Director of Regulatory Affairs and will have strong relationships with Global Regulatory Affairs, CMC, CRO’s, vendors, consultants, manufacturing and research sites.
- Key point of contact to lead US regulatory strategies for development and approval of new drugs/biologics. Interface with global RA team members to coordinate regulatory strategy and represent RA team in Global Project and RA programs.
- Support general RA oversight activities to US RA team, oversee planning, implementation, and maintenance of the regulatory operational management (including regulatory submission management, clinical supply management, regulatory compliance and management of drug development SOPs). Interact with project team members in assessing and reviewing data for regulatory submissions. Provide strategic and operational regulatory support to CMC, Non-clinical, Clinical, Submissions, and other groups as necessary.
- Act as point of contact for regulatory agencies in support of North American development projects and foster an excellent working relationship with agency personnel, regulatory consultants, CROs, and vendors. Provide regulatory intelligence, including interpretations of applicable or newly issued regulations and guidelines, and business events that may affect the competitive landscape of projects in development. Keeps project team abreast of regulatory decisions, issues, new regulations and challenges.
- Create, implement, and oversee regulatory submissions and document management for assigned projects (IND submissions, Meeting Briefing Packages, Pediatric Study Plans, Orphan Drug Designation Requests, Protocol Amendments, Information Amendments, Safety Reports, Annual Reports, DSURs, DMF Updates, CMC, clinical and pre-clinical amendments). Lead initiative for transition to global electronic submissions.
- Prepare SOPs for Regulatory Affairs, contribute to preparation of organizational SOPs, and review Drug Development SOPs for overall compliance.
- Expand corporate knowledge base of regulations and guidelines governing the research, development, and marketing of drugs and biologics. Assist in the development of training programs and provide educational training to team members
Experience & Skills Required
- 7 years of Regulatory Affairs experience with a preference toward experience developing biotech products in oncology, immunology, or rare diseases.
- Strong direct experience interacting with FDA and regulatory agencies is highly desired.
- Strong RA knowledge and business acumen pertaining to regulatory strategy at the preclinical and clinical stages of drug development. Broad knowledge of the pharmaceutical industry including product development, regulatory affairs, manufacturing, quality control, sales, marketing, legal, finance, etc.
- Expert knowledge of FDA processes from beginning to end as well as experience with the preparation and review of regulatory submissions. Demonstrated expertise in FDA pre-IND and/or FDA IND filings
- Strong project management experience ability to collaborative across organization to create a unified cohesive regulatory approach. Strong attention to detail in composing and proofing materials, establishing priorities and meeting deadlines.
- Excellent writing skills, oral and interpersonal communication skills.
- Strategic thinking, creative problem solving and effective negotiating skills.
- Ability to lead and influence innovation and change.