Senior Regulatory Affairs Director - Clinical Development

Highly Competitive
  1. Permanent
  2. Officer /Associate
  3. Sweden
Gothenburg
Posting date: 21 Feb 2019
RA.PL.21807_1550749676

ProClinical are advertising a Senior Regulatory Affairs Director vacancy with a global pharmaceutical company with leading products across various therapeutic areas. This organisation, which focuses on pursuing world-class medicines in innovative ways, is seeking for an experienced incumbent to join them in Sweden.

Job Responsibilities:

  • Developing and implementing regulatory strategy for a product, or group of products, and ensuring that that said strategy delivers a rapid approval.
  • Identifying the needs of businesses, markets, and patients.
  • Acting as Global Regulatory Lead (GRL) for a product, or group of products.
  • Planning and constructing global dossiers and cores prescribing information.
  • Developing and implementing innovative strategies to maximise the likelihood of regulatory success.

Skills and Requirements:

  • A Bachelor's degree in a science related field and/or other appropriate knowledge/experience.
  • Previous experience in attending and/or helping a team prepare for a Major Health Authority interaction.
  • At least 5 years of experience or equivalent of regulatory drug development, including product approval/launch.
  • Expert knowledge of regulatory affairs within one or more therapeutic areas.
  • A broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g., Global, European, International, Marketing Company, or experience at a health authority.
  • Proven leadership and program management experience.
  • Ability to think strategically and critically evaluate risks to regulatory activities.
  • Ability to work strategically within a complex, business critical and high-profile development program.
  • Successful contribution to a major regulatory approval at a global or regional level.
  • A scientific and clinical understanding of the regulatory sciences.
  • Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skill.

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 Pontus Larsson on +44 203 319 3030 or upload your CV 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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