Executive Director, Regulatory Affairs
Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in their search for an Executive Director, Regulatory Affairs.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Directs global regulatory strategies for priority projects and programs.
- Designs and provides specialist guidance on development and implementation of global clinical and pre-clinical regulatory strategies.
- Supports development of the late-stage clinical development plan. Directs regulatory activities related to global life cycle management of products.
- Identifies, assesses, and mitigates regulatory risks associated with product development.
- Develops and maintains excellent rapport and relationships with relevant regulatory agencies in the representation, influence, and negotiation around company’s strategic regulatory plans.
- Represents the Regulatory strategy and function, and collaborates effectively at all levels internally and externally.
- Prepares or drafts all documentation related to company regulatory submission packages, development of internal documentation practices, relevant SOPs.
- Develops regulatory professionals who are developing expertise across various drug development phases or therapeutic areas.
- Requires a BS/ MS or other degree relevant to life science discipline. An advanced degree is preferred (PharmD, MSc, PhD, MD, MBA).
- Requires 10+ years pharmaceutical/biotechnology industry experience with functional/ technical management experience. A Minimum of 5 years in Strategic Regulatory Affairs leadership is required. Supervisory experience of Regulatory Operations function is Preferred.
- Must have expert knowledge and demonstrated experience in driving oncology programs through submission to approval.
- Experience and strong knowledge in neuroscience drug development is highly preferred.
- Requires expertise in the preparation of major regulatory submissions, supportive amendments /supplements and responses to inquiries.
- Expert knowledge with regard to oncology regulatory landscapes in the US, EU, Japan is required.
- Knowledge of ROW is preferred.
- Comprehensive knowledge of applicable regulations and experience in interpretation of regulations, guidelines, policy statements, etc. is required.
- Must have demonstrable success in interacting with relevant regulatory authorities.
- Requires demonstrated excellent leadership and communication skills.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.