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.

Specific Responsibilities:

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

Physical Requirements:

Sit for an extended amount of time in front of the computer. #LI- AM2

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