Specialist Regulatory & Clinical Affairs

Birn + Partners

  • Vejle, South Denmark


  • Permanent

  • Full-time

Specialist Regulatory & Clinical Affairs

As part of an ambitious growth plan Fertin Pharma continuously strive to improve the footprint across the world. Fertin Pharma aims to obtain market authorizations mainly in collaboration with pharmaceutical companies or as own portfolio ready for licensing. So now they seek an experienced and committed Specialist, Regulatory and Clinical Affairs, who is passionate about working in the regulatory and clinical area in a global perspective.

The Regulatory and Clinical Affairs function is involved in strategy and documentation of all development projects. Fertin plan, coordinate and collaborate on establishing the CMC/Quality part of the regulatory dossier and are the important link to their regulatory counterparts at the customers. Fertin take lead in the process of responding to questions from the authorities and are an integrated part of life-cycle management activities post-approval.

THE JOB

  • You will work in development projects, where you will be expected to propose the best regulatory approach.
  • You will plan, coordinate, and collaborate on establishing the CMC/Quality part of the regulatory dossier and you are the important link to our regulatory counterparts at our customers.
  • You will work with regulatory intelligence.
  • You will bring your experience into discussing regulatory approaches, documentation requirements and optimizing work processes.
  • Your main responsibilities will depend on your experience and interests, but you can expect it to encompass activities across all types of activities handled by the department.

This position reports to the Senior Manager Regulatory & Clinical Affairs.

WHO ARE YOU

Professional background

  • You hold a M.Sc. in pharmacy, biology or similar.
  • Your will preferably have experience from a position in regulatory affairs working with the CMC/quality aspects, alternatively from another department where you have significant experience with preparing CMC/Quality documentation for regulatory dossiers.
  • You deliver on your tasks in a structured and dedicated manner and thrive in a fast-paced environment with many different stakeholders.
  • You have good communication skills, and you are fluent in English.

Personal background

  • You are pro-active, enthusiastic and have a great energy.
  • You have a strong and genuine interest in the entire business and a commercial mindset.
  • You are structured, detail oriented and solutions oriented.
  • You have the courage to go with “good is good enough”.
  • You are robust, innovative, service minded and pro-active.
  • You are strong in building and maintaining relationships.
  • Ability to communicate cross functional and international.

FERTIN PHARMA OFFER

  • You will be a part of a culture and development organization where you can develop and use your competences with great impact on the entire business.
  • An opportunity to be a part of our ambitious growth strategy focusing on both maintaining and growing the core business and to diversify our product portfolio into new categories.
  • A socially and academically based work environment, where we meet each other with confidence and provide you with responsibility.

If you have any questions, please contact:

Jeanette Stids-Jønsby

Partner

Tlf.: +45 20 30 10 13

Application deadline:

As soon as possible

Birn + Partners

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