Regulatory Affairs Senior Specialist

Job Details: Regulatory Affairs Senior Specialist
Full details of the job.

Job Title of Vacancy
Regulatory Affairs Senior Specialist

Vacancy No
VN1967

Category
Clinical, Medical and Regulatory Affairs

Contract Type
Permanent

Contract Duration
Full Time / Part Time
Full Time

Location
Vejle, Denmark

Job Advert
Fertin Pharma has ambitious plans to grow our business in established markets (North America and Europe). The focus is within select consumer health categories with a focus on digestive health and dietary supplements and in the 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. The Regulatory specialists are split in a team operating within commercial projects and a team operating within market expansions and Life-cycle Management of our product portfolio. We have an open-minded way of working and focus on collaboration across our areas of responsibility and competencies. We encourage a high degree of knowledge sharing to ensure that our deliveries are solved in the best way and that we can develop our capabilities and competencies at the same time.

Main Responsibilities
To succeed in the role, you’ll possess a strong business acumen and be regulatory savvy within the following:
• Scoping of projects supporting Request for Quote and early planning.
• Project execution supporting the teams for prototype and analytical development, generation of data for the regulatory dossier etc.
• Regulatory submission processes.
• Handover to the Life-Cycle Management team.

Your category focus and main responsibilities will depend on your experience and interests, but we expect that you will focus on commercial projects with the following responsibilities:
• Regulatory strategy for the specific regulatory regime/country.
• Regulatory sparring partner for your colleagues from product development, analytical development, quality etc.
• Collaboration with RA colleagues establishing the CMC/Quality parts of the dossier if applicable.
• Collaboration with consultants, for instance RA strategies in countries outside of EU/US, eCTD publishing etc.
• Responsible for submission to the Authorities or alignment with our customers for the same.
• Support project management for risk management of activities with regulatory impact.
• Ensure progress of regulatory deliverables according to our Project Model.

Personal capabilities
As a Senior Regulatory Affairs Specialist, you are in the center of the project activities. You are aware of your stakeholders and understand the full value chain. You like to communicate respectfully 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 from other departments. You are motivated by teamwork, have a supportive attitude, and contribute to a good team spirit. You can manage a fast-paced everyday life.

Core competencies, knowledge and skills requirements
• You hold a M.Sc. in pharmacy, biology, chemistry or similar.
• You have a minimum of 5 years’ experience from a position in regulatory affairs working with regulatory activities like CMC, labelling/claims or other relevant aspects, alternatively from another department where you have significant experience with preparing CMC/Quality documentation for regulatory dossiers.
• You can integrate your theoretical knowledge 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, in both writing and speaking, as well as your communication skills will enable you to act in an international working environment.

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 and regulatory regimes.
• A position where you will be able to influence the way we work and bring your knowledge into play as we develop your competencies.
• A place in our highly dedicated team of junior and experienced colleagues and the possibility to work from our office in Vejle as well as long-distance.

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 on 7215 1617.

Applications Close Date
09 Feb 2025