Clinical-stage biotechnology company pioneering
the research and development of novel multi-targeted interventions to treat
complex diseases and improve health. Our product candidates are generated from
our proprietary, human‑focused development platform and harness the power of
endogenous metabolic modulators (EMMs), a broad family of molecules that
fundamentally impact and regulate human metabolism.
The Associate Director, Regulatory will be responsible for developing and implementing regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will, with a high sense of urgency, provide operational and strategic regulatory input to cross-functional teams responsible for global programs. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
· Works with manager to develop and direct innovative and effective regulatory strategies in support of portfolio.
· Provides input on regulatory issues for assigned products; actively collaborates with management and cross functional colleagues within (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
· Managing regulatory documentation and correspondence to ensure required traceability and documents repository
· May represent as point contact with FDA, including providing support for and coordination of regulatory meetings and information package development.
· Coordinates submissions to FDA and ex-US regulatory authorities in support of ongoing development and marketed product programs, e.g., IND and NDA Life cycle maintenance.
· Act as primary regulatory submission project manager and coordinator across program with cross-functional partners.
· Critically review regulatory documents in addition to performing quality control review for accuracy, completeness, and conformance to appropriate regulations, guidelines, and SOPs
· Assist in the preparation, compilation, and organization of regulatory submissions (e.g. INDs, BLAs, MAAs, annual reports, IND amendments, BLA supplements, etc.) and ensure timely submission of above in accordance with title 21 CFR and FDA, EU and ICH guidelines.
· Conduct research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy
· Stay abreast of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.
· Highly conversant and knowledgeable of new and emerging regulations and guidance
· Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.
· Knowledge of regulatory submissions format and structure (eCTD)
· Ability to manage complex issues and coordinate multiple projects simultaneously
· Effective organizational planning and project management skills
· Ability to work across different projects in a fast-paced global environment and manage multiple activities, priorities and deadlines
· Strong interpersonal and written/verbal communication skills
· Analytical approach to work with excellent attention to detail
Education and Experience
· Bachelor’s Degree in related discipline with a minimum of 5 years of pharmaceutical or biotech experience
· Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.
· Experience in global development of products through all stages of development including pre-approval and marketed compounds.
If you are interested, please send resume to: