Regulatory Specialist

7 days ago


Espoo, Uusimaa, Finland GlaxoSmithKline Full time

Regulatory Specialist - 1-year temporary contract.

Join our team as the Regulatory Specialist for a specified product portfolio This exciting role encompasses the responsibility for both national and central licenses, as well as projects that are still in development.

Be the regulatory responsible for your assigned product portfolio, offering your expertise in cross-functional settings to support and drive our business forward.

If you are passionate about regulatory affairs and ready to make a significant impact, we want to hear from you

Key Responsibilities include, but are not limited to:

  1. Prepare and submit high-quality regulatory submissions in compliance with local and European requirements, ensuring timely delivery.
  2. Interact effectively with authorities and collaborate with Headquarters to respond to inquiries.
  3. Update local labelling (SmPC, PIL, pack-label, and compendium) in Finnish and Swedish language to ensure compliance with local regulations.
  4. Ensure pack artwork complies with legislation and GSK processes.
  5. Deliver high-quality local translations in Finnish and Swedish agreed with internal partners, according to SOP and timelines.
  6. Regularly update regulatory databases to maintain compliance.
  7. Keep fully aware of local and EU regulatory requirements and GSK Regulatory Processes and Policies.

Why you?

Basic Qualifications & Skills:

  1. BSc or MSc degree in Life Sciences, Pharmacy, or a related field.
  2. Relevant (1-3 years) experience in regulatory affairs and the pharmaceutical industry.
  3. Basic understanding of regulatory affairs and the pharmaceutical industry.
  4. Understanding of regulatory databases and the importance of maintaining compliance.
  5. Good understanding of IT systems and ability to learn and adapt to new processes in a timely manner.
  6. Ability to manage tasks independently.

Preferred Qualifications & Skills:

  1. Ability to assist in regularly updating regulatory databases to ensure accuracy and compliance.
  2. Strong organizational skills to ensure timely delivery of translations and regulatory documents.
  3. Able to influence and to liaise with internal and external stakeholders.

Closing Date for Applications – 21st February 2025 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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