Regulatory Specialist

2 days ago


Vejle kommune, Denmark Vectura Fertin Pharma Full time
Job Details: Regulatory Affairs Senior Specialist

Job Title: Regulatory Affairs Senior Specialist

Vacancy No: VN1967

Category: Clinical, Medical and Regulatory Affairs

Contract Type: Permanent

Contract Duration: Full Time

Location: Vejle

Job Advert: Fertin Pharma has ambitious plans to grow our business in established markets (North America and Europe) within select consumer health categories focusing on digestive health, dietary supplements, and NRT pharma categories. To support this aspiration, we are looking for a Senior Specialist to expand our team of Regulatory Specialists focusing on commercial projects.

Our Team: The Regulatory Affairs department holds 16 skilled employees based in Vejle, split into teams operating within commercial projects and market expansions and Life-cycle Management of our product portfolio. We encourage a high degree of knowledge sharing to ensure effective delivery and development of capabilities.

Main Responsibilities:

  1. Scoping of projects supporting Request for Quote and early planning.
  2. Project execution supporting teams for prototype and analytical development, generation of data for the regulatory dossier.
  3. Regulatory submission processes.
  4. Handover to the Life-Cycle Management team.
  5. Regulatory strategy for specific regulatory regimes/countries.
  6. Serve as a regulatory sparring partner for colleagues from product and analytical development, quality, etc.
  7. Collaboration with RA colleagues on CMC/Quality parts of the dossier.
  8. Collaboration with consultants for RA strategies in countries outside of EU/US, eCTD publishing.
  9. Responsible for submission to Authorities or alignment with customers.
  10. Support project management for risk management of activities with regulatory impact.
  11. Ensure progress of regulatory deliverables according to our Project Model.

Personal Capabilities: As a Senior Regulatory Affairs Specialist, you will be central to project activities, aware of stakeholders and the full value chain. You will communicate respectfully across the organization, translating regulatory requirements into understandable language for colleagues. You will be motivated by teamwork, have a supportive attitude, and contribute to a good team spirit while managing a fast-paced environment.

Core Competencies, Knowledge and Skills Requirements:

  1. M.Sc. in pharmacy, biology, chemistry or similar.
  2. Minimum of 5 years’ experience in regulatory affairs or a related field.
  3. Ability to integrate theoretical knowledge into operational and tactical practice.
  4. Proactive, systematic approach to establishing and discussing regulatory strategies.
  5. Fluency in English, both written and spoken, with strong communication skills for an international working environment.

We Offer:

  1. Opportunity to be part of our ambitious growth strategy.
  2. Influence on work processes and development of competencies.
  3. A place in our dedicated team with the option to work from our office in Vejle or remotely.

Send your cover letter and CV as soon as possible via the link below. Interviews will be conducted on an ongoing basis. For further information, please contact Senior Manager Regulatory & Clinical Affairs, Karina Jakobsen at 7215 1617.

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