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Required – Sr Director, Regulatory Research!
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Job Details

Title: Sr Director, Regulatory Research
ID: 8341
Employment Type: FTE
Location: UK – London
Specific Location: London

Description

 

Sr Director, Regulatory Research

Department / Cost Center: Regulatory Affairs

Reports to (Job Title): Executive Director, Regulatory Affairs

Job Code:

Location: London

Date Prepared: September 2015

 

 

SUMMARY DESCRIPTION

This is a unique role to BioMarin and a chance to be involved in both Regulatory Intelligence and Core Regulatory Affairs. You will be part of a strong and fast growing Regulatory team with Global exposure and a patient focus.

BioMarin is an Ultra Rare and Orphan Drug company with a fast moving pipeline and five products already on the market.

 

RESPONSIBILITIES

The Director of Regulatory Research is responsible for investigating and analyzing the regulatory precedence for FDA and EMA approvals across several therapeutic areas. In this role, the candidate will identify the development programs used to support FDA and EMA license applications and identify the issues raised as well as trends during the health authority review process.

The candidate will provide recommendations to project teams and senior management on regulatory pathways and development programs including clinical trial designs to support NDA/BLA or CTA approvals. The individual will be responsible for developing and maintaining a library of preclinical and clinical development information on all compounds of interest to BioMarin.

The candidate will keep senior management apprised of FDA and EMA decisions and proposals, regulatory developments, identify and evaluate both changes in the regulatory environment and new regulatory trends.

 

SCOPE

Office based, some travel may be required.

 

EDUCATION

BS is required, advanced degree PhD or MD is preferred.

 

EXPERIENCE

  • Extensive experience in the healthcare industry, including at least strong experience in Regulatory Affairs are required.
  • The candidate must have substantial regulatory/clinical Phase I to Phase III development experience.
  • Extensive research and analytical skills and attention to details are essential to thoroughly research and document the details of the development programs.
  • Experience in identifying trends in regulatory research information.
  • Experience in European Regulatory Affairs and procedures would be beneficial.
  • Proven ability to identify unique and creative regulatory strategies appropriate for the FDA and EMA approval of both biologics and small molecules.
  • Strong collaborative skills, as this position requires close working relationships with both internal and external stakeholders
  • Experience in using regulatory data bases (e.g. Cortellis, Pharmapendium) essential.

 

CONTACTS

Global Regulatory Affairs teams, FDA/ EMA.

 

EQUIPMENT

Laptop/ Phone.

 

 

Note: This description is not intended to be all-inclusive or a limitation of the duties of the position.  It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

 

 

To Apply – Copy & Paste the link below,

http://chk.tbe.taleo.net/chk06/ats/careers/apply.jsp;jsessionid=CD7A6D5B3BD89669BCDDE697A1111F25?org=BMRN&cws=1&rid=8341



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