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Director Regulatory Affairs CMC

Director Regulatory Affairs CMC

Job Title: Director Regulatory Affairs CMC
Contract Type: Permanent
Location: San Francisco, California
Industry:
Salary: Negotiable
Start Date: asap
Reference: HQ00051692
Contact Name: Pavlina Bullaj
Contact Email: p.bullaj@sciproglobal.com
Job Published: February 06, 2017 15:41

Job Description

Director Regulatory Affairs CMC

Industry: Pharmaceuticals/ Biotech

Location: San Francisco

One of my key clients is currently looking for a Director Regulatory Affairs CMC based in their head office in San Francisco.

As the Director Regulatory Affairs CMC you will be solely responsible for implementing & leading the CMC regulatory submissions. You will ensure that all appropriate communications with internal resource & staff as well as business partners and regulatory bodies is smooth & effective.

Responsibilities

  • Ensuring all CMC Regulatory Affairs deliverables are completed within defined timelines and meet regulatory and other company guidelines
  • Oversees, coordinates and delivers on CMC regulatory submissions and other relevant regulatory documentation
  • Provides regulatory CMC expertise and leadership to cross-functional teams and other groups
  • Serves as the primary CMC RA representative on one or more projects at any one point in time
  • Analyzes data, the regulatory environment and business objectives to recommend priorities
  • Provides internal teams with direction on regulatory authority interactions
  • Develops regulatory risk management and contingency plans. Communicates plans to management, as appropriate
  • Participates as a standing member in various teams, dependent upon assigned projects and the associated programs, coordinates cross-functional contributions

Qualifications

  • Bachelor's Degree required (life sciences disciplines strongly preferred)
  • Average of 5 or more years' relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing
  • Broad understanding of international regulations, processes and issues in drug/biologics development.
  • Experience as a regulatory contributor for global original IND/NDA/MAA filings in the US or Europe is preferred
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
  • Sound knowledge of the pharmaceutical/biotechnology industry, the multiple functions and roles involved in the product development process.
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
  • Outstanding written communication skills

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