Manager LCM, Regulatory Affairs

Job Details: Manager LCM, Regulatory Affairs
Full details of the job.

Job Title of Vacancy
Manager LCM, Regulatory Affairs

Vacancy No
VN1615

Category
Clinical, Medical and Regulatory Affairs

Contract Type
Permanent

Contract Duration
Full Time / Part Time
Full Time

Location
Vejle, Denmark

Job Advert
Our Business:
At Fertin Pharma, our sole mission is to support healthier living. We are on a growth journey and our strategy incorporates new pharmaceutical categories and forms, new regulatory regimes, and progression into new markets for existing products. To ensure that the Regulatory Department in Fertin can support the strategy we are looking for a Manager to join our team and shape the future together with us. In the role, you will be an active part of the Quality & RCA management team with 5 manager colleagues, where you will provide your input for compliance, optimizations and relevant regulatory issues and activities.

Our Team:
The Regulatory and Clinical Affairs department holds 15 skilled employees, 14 in Vejle and 1 colleague at Fertin India R&D site in Mumbai all referring to the RCA Senior Manager. Due to an ambitious growth strategy for Fertin Pharma the RCA team will be hiring 4 new RA specialists and the team will be split into Clinical Affairs, Regulatory Affairs Life-cycle Management (RA LCM) and Regulatory Affairs Projects. The RA LCM team is looking for a dedicated manager who will contribute to develop the structure and ways of working for the activities in the team. Further, knowledge-sharing is a key word in the RCA department and as our new manager you will focus on non-silo thinking and collaboration between the two teams.

Main Responsibilities:
As the Manager for the RA LCM team, you will lead a team of 11 talented and dedicated regulatory affairs and pharmacovigilance specialists, providing guidance and mentorship while fostering a collaborative and knowledge-sharing environment. You will also ensure collaboration cross-functionally with other departments providing regulatory support.

Outside of this, your will be responsible for:
• Actively participating in planning, budgeting and resource allocation for activities related to the LCM team.
• Deployment of QA and RCA strategy and goals to team level and ensure results.
• Overseeing RA LCM activities on current project portfolio incl. maintenance and expansion of Marketing Authorizations.
• Managing of Fertin´s system and procedures for vigilance and pharmacovigilance incl. contact with external QPPV.
• Oversight of Regulatory Surveillance and pharmacovigilance covering own MA’s globally.
• Support to BPA of regulatory approval, pharmacoviglance, vigilance.

Core competencies, knowledge, and skills requirements:
• Relevant education with regulatory/pharma/quality or related experience.
• Experience with authorization of drugs and active ingredients following US FDA and EU requirements is an advantage but not required.
• Solid leadership experience incl. experience with change management
• As a leader, you contribute to a competence-developing environment in the Regulatory Affairs function with a focus on knowledge sharing.
• Motivated by teamwork with a supportive attitude, contributing to a good team spirit.

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 positive culture valuing teamwork, collaboration, and open communication.
• A position where you will be able to influence the way we work and bring your knowledge into play as we develop your competencies.
• Flexible working hours and the possibility to have days working from home.
• Free choice scheme with the option of extra holidays.

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 Affairs, Karina Jakobsen on [email protected].

Applications Close Date