Head of Regulatory Affairs

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About the job

Looking for a new exciting career opportunity? 

Invenia Group is partnered with an international pharma company specialised in the development, approval and marketing of generic drugs for human and veterinary medicines. To strengthen their generic finished dosage form department, they are seeking an experienced regulatory professional to take on the newly created global role as Head of Regulatory Affairs.

Key Responsibilities:

  • Leading and coordinating the regulatory affairs activities of the projects and the RA group
  • Development of regulatory strategies for global markets, with a focus on Europe and the US
  • Development and continuous improvement of internal RA processes and interfaces with other disciplines to improve efficacy.
  • Continuous monitoring of the regulatory landscape, adopt and implement related guidelines and legislation.
  • Keep and grow the regulatory affairs network with company partners.
  • Provide regulatory guidance to project teams in early project phases, i.e. evaluation and development.
  • Regulatory evaluation and review of technical documents and dossiers for appropriateness for development co-operations and submission.
  • Lead projects through the regulatory phase from dossier compilation until obtaining the MA.
  • Compilation of documents to obtain dossiers ready for submission, and create related applications.
  • Coordination and lead regulatory MA procedures in global territories.
  • Maintenance of MAs, in particular coordinates RA activities between customers and manufacturers
  • Review, coordination and compilation of documents to update and extend MAs.
  • Coordinate and lead variation procedures
  • Lead continuous and intense related communication between customer, manufacturer and internal functions.

Skills & Experience Required:

  • You have a scientific academic degree.
  • You have several years of professional experience in the pharmaceutical industry in the field of Regulatory Affairs, preferably with some additional insight in Quality Assurance and Production.
  • You are used to having oversight across multiple active projects and managing with priorities.
  • You have in-depth knowledge of the relevant regulations and procedures to obtain and maintain marketing authorizations in Europe, and preferably additional regions of the world.
  • You are experienced in developing regulatory submission strategies for several regions of the world, in particular Europe.
  • You have an established personal network across companies and relevant associations that help to identify trends in the industry and authorities and thus prevent issues and solve challenges.
  • You have natural and cooperative leadership skills and preferably some experience in leading a group of scientists and associated technical staff in regulatory affairs or related areas.
  • You show a very high level of commitment, flexibility and reliability and enjoy working in a team.
  • Independent, careful and goal-oriented work.
  • You enjoy business contact with people of different regions and cultures.
  • You have very good communication skills, in German and English.

Sound interesting? Apply to find out more.