Global Regulatory Lead
A global biotechnology corporation situated on the East Coast is seeking to hire a Global Regulatory Lead through the end of 2018. This individual will be expected to develop and direct the global regulatory strategy, objectives, policies and programs pertaining to development and marketing of drug and/or biological products.
The Global Regulatory Lead is responsible for: 1) designing and implementing regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations. 2) Provides proactive guidance to internal groups (including: including CMC, Operations, Labeling, International, Advertising/Promotion and Intel/Policy) based on technical and regulatory knowledge towards development of strategic and tactical plans. 3) Identify and assess regulatory risks associated with product development for assigned projects. 4) Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, including: INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. 5) Serve as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships. 6) May supervise a group of Regulatory Affairs Associates and may be responsible for creating and implementing department SOPs.
Duration: 4-months (through 2018-options to renew contract)
Compensation: $85-90 per hour
Location: Exton, Pennsylvania
- Education: BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
- At least 8-15 years of Regulatory Affairs experience, including equivalent experience in thebiopharmaceutical industry-global experience is required.
- 2-5 years of management experience preferred.
- Must have the ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
- Willing to conduct some domestic and international travel (<5%).
- Excellent interpersonal, communication, analytical, managerial, and organizational skills.
- Must be a problem solver and have strong attention to detail.
Sthree US is acting as an Employment Business in relation to this vacancy.