RA Director

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP
  3. United States
Maryland
Posting date: 11 Jun 2019
RA.NW.23833_1560269567

ProClinical is currently seeking a Director of Regulatory Affairs for a biotechnology company focused on biological therapies for people with serious diseases. The Successful candidate will be responsible for assigned projects and all the regulatory affairs activities by providing expertise to the client's development programs. Additionally, the ideal candidate will have experience gained in biologics and the preparation of late stage regulatory fillings supported by excellent leadership skills.

Job Responsibilities

  • Provide regulatory leadership and support to cross functional development project teams.
  • Responsible for the US regulatory activities associated with the project teams.
  • Develop regulatory strategies and target labelling to support development of products.
  • Manage, prepare, co-ordinate and be responsible for the submission of the documentation supporting regulatory submissions to the US and wider international regulatory authorities.
  • Point of contact of all regulatory requirements and guidelines globally.
  • Contribute to the establishment and development of procedures and working practices.
  • Oversee regulatory review of clinical trial labelling and CMC submissions for regulatory compliance, in junctions with the Director of Regulatory CMC.
  • Review the quality of detailed scientific and technical information are presented clearly and supporting conclusions are adequately evidenced by the data.

Skills and Requirements

  • BS with 8-12 years' experience or MS, PharmD, PhD, or MD with 5-10 years' experience.
  • Knowledge of US regulatory requirements and extensive experience with submissions gained within drug development. Global experience desirable. Experience in working cross functionally and globally within Regulatory Affairs.
  • Experience in managing, preparing, submitting INDs/CTAs, BLAs/NDAs, and MAAs. Submission of at least 1 NME BLA/NDA is highly desirable.
  • Experience in preparing and conducting Health Authority Meetings (FDA required).

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 Nicholas Walker at (+1) 646-367-2908 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.

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