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Job Details

Senior Director, Regulatory

Company: SciPro
Location: San Francisco
Reference: HQ00REG
Closing Date: 19 Jan 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

The Regulatory Affairs Professional (Director) will be responsible for the comprehensive management of regulatory aspects of the company’s development projects while actively contributing as a member of the project team(s). This position will also require key contributions to department and company initiatives related to regulatory affairs operations and strategy. ...

Requirements:

The Regulatory Affairs Professional (Director) will be responsible for the comprehensive management of regulatory aspects of the company’s development projects while actively contributing as a member of the project team(s). This position will also require key contributions to department and company initiatives related to regulatory affairs operations and strategy.

Duties and Responsibilities

* Responsible for working with the project team to identify an optimum regulatory strategy for assigned projects. Able to lead teams in examining regulatory strategy options.
* Expected to independently interact with regulatory authorities, and outside consultants when needed. Able to independently prepare and lead a team through a regulatory meeting exercise.
* Able to write, review and edit regulatory documentation, ensuring it is fit for purpose, and to serve as a resource for regulatory document authors regarding the appropriate content of submissions.
* Supervises and provides guidance to other regulatory personnel as assigned.

Qualifications

* Education: Minimum Bachelor’s degree; studies in science and advanced degree desirable
* Specialized knowledge that would be desirable and supportive of success in this position includes:

* Experience working on promotional materials and with OPDP (formerly DDMAC).
* Experience with US and international management of post-marketing CMC changes
* Experience in pediatric drug development and understanding of US and EU regulations related to pediatric requirements
* Experience in the management of core labeling and/or US labeling
* Understanding of regulatory requirements for and experience with submission of applications (IND / NDA) in eCTD format
* Ability to create and manage detailed timelines and/or experience with tracking regulatory activities across disciplines and territories
* Experience in other key functional areas, (e.g., toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics) appreciated

* Experience: Minimum 10+ years progressive Regulatory Affairs or relevant experience

Apply for this job: Senior Director, Regulatory

Contact Information:

Address:  Head Office
4th Floor, 150 Leadenhall Street, London
EC3V 4TE
England
Tel:  +44(0)203 327 3072
Website:  Visit Our Web Site

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