Head of Regulatory Affairs

Contract/Perm: Contract Job Title: Head of Regulatory Location: Remote, anywhere in the US Must-haves: Global Regulatory experience Working with different agencies 15+ years of regulatory experience Nice to have: Rare Disease Biotech experience Description The Head of Regulatory Affairs will provide strategic leadership and key insights that will allow the organization to operate collaboratively and proactively, interacting closely with internal peers and externally with FDA, EMA, and other key stakeholders. This individual will direct and coordinate activities in regulatory affairs and work with the executive team in formulating strategy, enhancing performance, and administering relevant policies around this critical functional area. The candidate will help to inform the design and execution of clinical trials, as well as manage all regulatory submissions for the company. This position will report to the CEO. Responsibilities: Provide high-level strategic and operational regulatory direction on clinical development programs in the rare disease space. Work closely with clinical development in designing and implementing development and launch strategies and life cycle planning. Lead IND, NDA, BLA activities (e.g., Preclinical, Clinical) with functional experts Advise and lead opportunities with Orphan Drug Designation (ODD), Fast Track & Breakthrough Therapy Designations (FDA), Accelerated Approval (FDA) & PRIME (EMA), START Pilot Program, and Rare Disease Evidence Principles (RDEP). Lead, develop, and manage the Regulatory Affairs team Contribute to development of best practices and standardized processes for filing of regulatory submissions Contribute to internal regulatory policies and procedures to achieve best practices and work processes Requirements: Degree in Life Science and experience working as an RA project lead for IND and/or NDA filings Minimum 15+ years of documented professional experience at a Regulatory Affairs position from a pharmaceutical/biotechnology company developing small molecules Have a strong understanding of clinical development and how to present clinical data to FDA Experience with labeling development and in close collaboration with marketing and market access departments Extensive regulatory experience including IND/CTA, NDA/BLA/MAA, lifecycle management, labeling, interactions with Health Authorities, and experience in developing short- and long-term regulatory strategies to rapidly deliver innovative products to the market Demonstrated an ability to collaborate effectively with multiple functions, including Research, Development, Clinical, CMC, and Quality Preferred candidates will have a broad blend of experience in Regulatory Affairs and have worked directly with FDA and other international agencies on clinical and regulatory matters Represent the Company's interests with national government agencies, industry associations and/or other organizations with legislation, regulations and/or guidelines that impact the business in global markets. Must have a proven track record of success in developing short- and long-term regulatory affairs and clinical strategies to deliver innovative medicines to the market Recent filing experience with global, U.S., and European regulatory authorities required Deep familiarity with the overall drug development process, especially related to clinical trial requirements for submissions Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements. Remain well-informed of key global guidance documents, regulations, or directives. Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs Work with peers to develop standard operating procedures and departmental guidelines. Experience with Rare Disease and/or Orphan Drugs development Leadership polish and gravitas Previous successful experience leading/participating in FDA / EMEA or other regulatory meetings Excellent writing, communication, and presentation skills