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Regulatory Affairs Manager

4 weeks ago

Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

Confidential

Sweden - Stockholm

Apply now
PharmaRelations is the market leading Life Science Group in the Nordics. Operating across the Nordics with offices in Sweden, Denmark, Finland, and Norway, we provide expert services that span clinical to post-marketing phases. Our Regulatory interim team is expanding, and we are seeking a consultant to a first assignment as Regulatory Affairs Manager.

Key responsibilities:

  • Support Global Regulatory Affairs in the EU on new applications to obtain marketing authorizations and timely submission of post approval maintenance activities like renewals and variations. Ensure submission and approval of high-quality regulatory applications within planned timelines.
  • Ensure that Product Information complies with local regulatory requirements and global labelling procedures and that updated Product Information is submitted, approved, and implemented within the designated internal and/or Ministry of Health timelines.
  • Product information translations and quality control of translations.
  • Communicate approval of new or revised Product Information to internal stakeholders.
  • Perform timely development/revision of new/existing packaging material, proof reading and approval of new/revised packaging materials.
  • Ensure national catalogue texts (such as FASS for Sweden and Felleskataloget for Norway) are accurate and updated according to latest available product information and internal and external requirements.
  • Ensure alignment and implementation of launch readiness initiatives.
  • Ensure implementation of and compliance with additional Risk Minimization Measures in the affiliate.
  • Interact directly or facilitate interactions with regulatory bodies as appropriate.
  • Collaborate with Medical, Marketing, Pricing and Reimbursement (PRA), Product Quality and Logistics to facilitate cross-functional activities within the business area. Participate in brand teams and provide regulatory updates and knowledge.
  • Contribute to the Nordic Regulatory teamwork and support Regulatory Affairs in the other Nordic countries when needed.
  • Ensure that internal Regulatory IT tools are up to date and accurate and actively use available tools to monitor regulatory plans.
  • Keep regulatory archive complete and up-to-date and to ensure that all current licenses and labels are readily available.
  • Support and participate in internal and external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.
  • Other ad hoc Regulatory Affairs tasks

Qualifications:

  • MSc in Pharmacy, or equivalent education
  • +5-7 years of experience in Regulatory Affairs
  • Fluent in Swedish and English, both written and oral. Additional skills in Nordic languages is a plus
  • Experience in managing a product portfolio, hence Product Life Cycle Management
  • Nordic experience from similar role

Why PharmaRelations?
We are offering a strategic role with significant impact on PharmaRelations' growth. You will have the opportunity to build and lead a safety team from the ground up and to work in a dynamic and collaborative working environment across the Nordics.

Joining PharmaRelations means being part of a forward-thinking community who is passionate about making a difference in patients' lives. We offer a challenging yet supportive work environment where innovation, creativity, and personal growth are encouraged.

PharmaRelations offer a place where there is room for you to excel, be valued and make a difference.

At PharmaRelations we aim to become the best place to work within Nordic Life Science Industry. We follow Great Place to Work's model, and our definition of "the best" is to get the highest results among all Nordic Life Science companies in the GPTW model. It is a challenging goal, but we strive to always continue to challenge ourselves to continuously improve and become a better employer for each year.

Apply today

For further information please do not hesitate to reach out to Shiva Hobbi Nowzari, shiva.nowzari@pharmarelations.se.

Please send in your application as soon as possible, as interviews are being conducted on a continuous basis. We look forward to hearing from you

Due to GDPR we do not accept applications via email.

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