Head Of Regulatory Affairs

Albion Rye Associates are proudly partnered with a global, oncology-focused biotech company located in Boston, Massachusetts. This position will report directly to the CEO.

The Head of Regulatory Affairs will provide strategic and operational regulatory leadership to the development, commercialization, and life-cycle management of assigned products. You will serve as the global regulatory lead on early-stage projects or specific indications of larger programs and/or as the regional regulatory lead. As the Head of Regulatory Affairs, you will play a substantial role in crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.

Roles & Responsibilities:

• Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.
• Plan and construct the global dossier and core prescribing information including product maintenance, supply, and compliance activities.
• Lead a Global Regulatory Team
• Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labeling that is identified by the business, markets, and patients.
• Lead preparation of the regulatory strategy document and target product labeling.
• Deliver regulatory milestones on your team including an assessment of risks and mitigation, emerging data, and the probability of success.
• Own the negotiations with health authorities and initiate and deliver key regulatory documents.
• Lead cross-functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
• Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

Education, Qualifications, Skills & Experience:

• Experience in Oncology
• Knowledge of Regulatory Affairs, working with products in early and late stages of clinical development
• Experience working within Regulatory Affairs on a global level
• Degree in a Life Sciences Related discipline