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Senior Regulatory Affairs Manager – Permanent

MarkerLondon CoinNegotiable

Vacancy summary

Reference: 07422

Job Type: Permanent

Date Posted: 11 October 2018

  • Excellent international opportunity
  • Working in a fantastic city
  • Huge scope for career progression

Senior Regulatory Affairs Manager – Permanent

An interesting opportunity to work within an innovative, leading biotechnology company who are continually carrying out ongoing research programmes and truly value their patient’s needs.

The role is focused on the development and implementation of regulatory strategy for emerging international markets. You will be responsible for providing the team with your regulatory support and expertise on assigned programmes with a significant focus on new drug applications and regulatory submissions.

KEY RESPONSIBILITIES:

  • Taking part in the development and implementation of regulatory strategy for new, emerging markets (Middle East, Russia, CIS territory etc.)
  • Leadership and support throughout the process of preparation, submission and approval of marketing applications and labelling
  • Making sure all documents are fully compliant on regulatory side
  • Looking after the relationships with local CRO’s
  • Check and review documentation from regulatory requirements perspective and supporting the specific country with the required documents for submission
  • Understanding of the impact of new regulations and guidance documents and preparing the options of possible process improvement for the team
  • Responsible for solving the problems and providing the team with the solutions

THE CANDIDATE:

  • Strong, relevant experience within regulatory affairs
  • Preferably a Life science/Pharmacy degree
  • Experience in creating submissions of documents for international markets
  • Project management and leadership skills
  • Ability to prepare strategy plans and present them to the team
  • Strong communication skills – both written and spoken with the ability to present key data to global management
  • Possessing knowledge and experience to be able to interpret the regulations related to drug development

Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.

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