15 days ago
My client is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. They are seeking a Director, Regulatory Affairs, who will be responsible for leading one or more drug development programs, with specific emphasis on global regulatory strategy, regulatory submissions, and interaction with global regulatory authorities. S/he must have a good understanding of clinical development strategies and health authority expectations for novel and complex oncology programs.
- Works closely with functional leaders to 1) create the optimal development path for company product candidates, 2) negotiate optimal development paths within internal cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks.
- Plans, manages, and creates Clinical Trial Applications, Market Applications and amendments.
- Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
- Leads cross-functional teams in preparing for health authority meetings.
- Ensures that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making.
- Works within the department and with other functional areas on process improvements.
Education and Qualifications:
- BS degree in life sciences. Advanced degree preferred (PhD, MS, PharmD).
- Minimum 10 years’ experience in regulatory affairs
- Late‑stage experience in oncology drug development.
- Experienced in the creation, submission, and negotiation of market applications preferred.
- Experienced in creating and negotiating the clinical-regulatory aspects of oncology programs.
- Able to write, edit, and/or collaborate on the development of high-quality clinical-regulatory documents. E.g., briefing books, investigator brochures, protocols, clinical study reports, clinical summaries.
- Able to write clearly and concisely, within agreed timelines.
- Able to simultaneously manage multiple projects and submissions, with flexibility to pivot based on new data, program changes, and/or external influences.
- High attention to detail and accuracy.
- High organizational and planning skills.
- Able to influence and negotiate professionally at various levels within cross-functional teams and with external partners, while maintaining positive working relationships.
- Excellent interpersonal, verbal and written communication skills
- Sit for an extended amount of time in front of the computer. #LI- AM2