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Regulatory Affairs Specialist

Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

Bachelor's degree in Life Sciences or Pharmacy, 5-10 years relevant experience in Regulatory Affairs, Experience with Marketing Authorization Applications, Strong familiarity with European Regulatory Authorities, Fluent in English and German.

Key responsabilities:

  • Prepare and submit Manufacturing License Applications
  • Manage post-approval regulatory processes
  • Monitor national and international regulatory guidelines
  • Serve as a liaison with regulatory authorities
  • Utilize software for documentation and data management
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ProductLife Group
501 - 1000 Employees
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Job description

PLG is seeking a motivated and detail-oriented Regulatory Affairs Specialist to join our growing life sciences company. In this role, you will ensure global compliance with regulatory requirements throughout the product lifecycle, from development and approval to post-market maintenance.


Responsibilities

Submission and Approval Process:

  • Prepare and submit Manufacturing License Applications (MLA) for new products and site transfers.
  • Lead the preparation and submission of Marketing Authorization Applications (MAA) across German and Global markets.
  • Support Technical/Site Transfer Applications for product launches and changes.


Lifecycle Maintenance:

  • Manage post-approval regulatory processes, including Variations, Renewals, and Marketing Authorization Holder (MAH) Transfers/Certificates of Analysis (COA).
  • Handle updates to product labeling and ensure compliance with approved documentation.


Regulatory Compliance:

  • Continuously monitor and maintain up-to-date knowledge of national (German), European, and international regulatory guidelines and legislation.
  • Ensure strict compliance with regulatory requirements and readiness for both internal and external audits.


Communication:

  • Serve as a key liaison between our company and regulatory authorities, facilitating clear communication and timely submissions.
  • Respond to internal inquiries and provide regulatory support to cross-functional teams.


Software Utilization & Data Management:

  • Use a variety of software packages to create correspondence, prepare documents, maintain spreadsheets, and manage databases (e.g., Microsoft Office Suite, Veeva Vault or comparable EDMS, LorenZ, Trackwise, PromoMat).
  • Efficiently locate and extract information and data needed for regulatory submissions and lifecycle maintenance.


Experience

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Master’s degree or higher is a plus).
  • 5-10 years of relevant experience in Regulatory Affairs, focusing on the German market.
  • Proven experience in the lifecycle maintenance of medical products.
  • Hands-on experience with Marketing Authorization Applications (MAA), Common Technical Documents (CTD), and product labeling.
  • Strong familiarity with European Regulatory Authorities and international regulatory frameworks.
  • Proficiency in regulatory software packages and databases, such as Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat, etc.
  • Fluent in English and German with excellent communication skills—both written and verbal, proficiency in additional languages is a plus.
  • Excellent organizational skills with the ability to prioritize tasks and deliver high-quality work in a fast-paced environment.
  • Experience in people management or coordination is a plus.
  • Previous experience in promotional/non-promotional activities is an advantage.

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
EnglishEnglishGerman
Check out the description to know which languages are mandatory.

Other Skills

  • Organizational Skills
  • Microsoft Office
  • People Management
  • Time Management
  • Detail Oriented
  • Communication

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