REGULATORY AFFAIRS SENIOR SPECIALIST, CMC EXPERT

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Vejle

REGULATORY AFFAIRS SENIOR SPECIALIST, CMC EXPERT


The Role

Fertin Pharma has a solid background in the Nicotine Replacement Therapy (NRT) category developing and manufacturing nicotine gum. However, as part of our diversification strategy we are expanding our activities with other active ingredients, other therapeutical areas and new pharmaceutical forms. Evaluation of new regulatory frameworks as PMTA and NDAs for US markets are part of our ongoing work. Building on our long history as a B2B company we are engaging with new customers for both European, North American and international markets in addition to progressing development opportunities by ourselves.

The Regulatory Affairs department holds 14 skilled employees in Vejle and 2 colleagues at Fertin India R&D site in Mumbai. The department is organized to support high flexibility and it will be a possibility to work long-distance.

The Regulatory Affairs function play a key role in all development projects and our specialists collaborate across the organization on strategy, documentation etc. We take lead in the process of responding to questions from the authorities and are an integrated part of life-cycle management activities post-approval. We are responsible for regulatory surveillance process and keep ourselves updated on the regulatory requirements and industrial guidelines.

Main Responsibilities

  • You will be responsible for evaluation and compilation of Chemistry, Manufacturing, and Controls (CMC) part of the regulatory dossier and you are the important link to our regulatory counterparts at our customers. You will be the expert on the field and the go-to-person both internally and towards our customers.
  • With your extensive experience within Regulatory Affairs you will bring your experience into discussing regulatory approaches, documentation requirements and optimizing work processes for regulatory dossier compilation and submission.
  • Considering current and future regulatory requirements you ensure that the content of CMC work packages and documentation are phased appropriate, meet state of the art regulatory expectations and enable smooth approval of regulatory submissions.

Your responsibilities and tasks will depend on your experience and interests, but you can expect it to encompass activities across all types of activities handled by the department.

  • Participation in regulatory processes to gain and maintain of European and non-European MAs for human medicinal products (application, renewal, variations) with emphasis on pharmaceutical quality aspects.
  • Provision of general guidance to other departments regarding quality aspects from drug development up to life-cycle management.
  • Participation and preparation of the informative texts for HCP and patients (SmPC, PL, labelling) with view to quality related details.
  • Contribution to Scientific Advice Meetings with regulatory authorities, concerning quality issues.

Personal capabilities

As a Regulatory Senior Specialist, you are in the center of the activities. You are aware of your stakeholders and understand the full value chain. You like to communicate across the organization and invite the regulatory function into discussions where needed.

You are focusing on the regulatory details – however you have the capability to translate the regulatory requirements into a language that can be understood by colleagues with another background.

You are motivated by teamwork, have a supportive attitude, and contribute to a good team spirit.

You are flexible and adaptive and can adjust rapidly to new, unknown, challenging situations.

As a team we work closely together and have high focus on knowledge sharing and a supportive environment. You are expected to contribute to further development of the CMC competences in the team.

Core competencies, knowledge and skills requirements

  • You hold a M.Sc. in Life Science as pharmacy, biology, chemistry or similar.
  • You have a minimum of 5 years’ 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 have advances theoretical knowledge within CMC/Quality documentation and can integrate it into practice on an operational and tactical level.
  • You are proactive, systematic and can establish and discuss a regulatory approach presenting risks and opportunities.
  • Your fluency in English both in writing and speaking, as well as your excellent communication and negotiation skills will enable you to act in an international working environment.
  • You have preferably experience working with regulatory processes in RIMS systems

We offer

  • 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 position where you will be able to influence the way we work and develop your competences
  • An opportunity to join a leading B2B pharma company undergoing change rooted in a successful journey within nicotine chewing gum and strong aspirations to grow beyond this
  • Possibility to work long-distance


Information og data

Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Vejle.

Jobbet er oprettet på vores service den 5.12.2022, men kan have været deaktiveret og genaktiveret igen.

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  • Apoteker
  • Vejle
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