Senior Director of Regulatory Affairs

At Proclinical, we are seeking an experienced regulatory strategy leader to fill the role of Senior Director/Director of Regulatory Affairs, based in Lexington, MA. The successful candidate will join a newly formed Regulatory Science and Pharmacovigilance (RSP) business unit, with an aim to bring about regulatory science-based innovation in drug development and commercialization. The position is highly visible to internal and external stakeholders and requires political savvy and agility in building consensus and defending the regulatory position with global health authorities.

Responsibilities

• Provide leadership to project teams to support the planning and conduct of non-clinical, clinical and CMC development leading to successful and fast registration.
• Identify issues from research, early development and evolving competitive intelligence that potentially would impact regulatory approval (risk analysis & mitigation).
• Manage development projects with multiple complex issues requiring extensive agency consultations and contingency and risk mitigation planning from IND through BLA.
• Develop strategies integrated with cross-functional project teams to facilitate timely submissions and approvals.
• Ensure completion of regulatory deliverables, according to agreed project timelines and development plans.
• Work with teams in different business units to formulate global regulatory plans and tactics.
• Lead compilation of dossier for INDs, BLAs and ensure readiness for submission to relevant authorities.
• Manage global regulatory sub-team for specific projects composed of regulatory CMC, regulatory operations, regulatory intelligence and regulatory managers responsible for major markets.

Skills And Qualifications

• PhD or PharmD in relevant life science discipline (higher education degree preferred).
• Experience gained in regulatory affairs and strategy 13+ years, via roles in the pharma/biotech industry, consultancy or regulatory health agencies
• 10+ years in regulatory development strategies, managing complex projects from early to late stages and FDA, EMA and other major agency consultations
• Track record of regulatory approvals in immune-oncology required.
• Understanding of the current EU and US regulations and the wider regulatory environment.
• Work effectively across functions in research, drug development and commercial organizations.
• Strong written, verbal, and interpersonal communication skills, including fluency in English (knowledge of other languages valuable).
• Able to undertake significant travel (approx. 30% a year).

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Reid Schalet at (+1) 6463672908 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.