The role is responsible for supporting endtoend regulatory life-cycle management activities for assigned products. This includes preparation and maintenance of global regulatory documentation, coordination of postapproval changes, and ensuring compliance with national regulatory requirements. Coordination of transverse projects such as address changes impacting all local contacts.
Key Responsibilities
- Preparation, Organization & Coordination of Local Regulatory Documentation
- Prepare, compile, and review countryspecific regulatory documentation (e.g., Module 1, administrative forms, declarations, national templates) in accordance with local health authority requirements.
- Support regulatory submissions including renewals, variations, PSURs/PBRERs, safety updates, label updates, and CMCrelated changes.
- Support to answer Health Authority questions
- Support for transverse projects such as safety compliance, gap analysis on new guidelines (i.e. new variation guidelines), survey on ad-hoc request (such as harmonization of SmPC for national registered products) or support for projects initiated by manufacturing sites
- Support to ensure compliance to IDMP or any other new regulation with focus in Europe
- Ensure that all documents meet formatting, quality, and content standards required for national submissions.
- Liaise with global/regional RA teams to obtain submission components and ensure alignment with global dossiers.
- Support in dossier preparation
- Upload of required documentation in our EDMS (Electronic Data Management System)
- Dossier submission for some EU procedure to submit the dossier via CESP (Common European Submission Portal) submissions (mainly for products registered under Decentralized or Mutual Recognition procedures) and European Medicines Agency (EMA) gateway PSUSA (Periodic Safety Update Single Assessment) and submissions for Centralized Products
Key Skills & Competencies Required
- Strong knowledge of global regulatory guidelines and understanding of the CTD/eCTD structure, especially Module 1.
- Experience in lifecycle management: renewals, variations, PSUR/PBRER submissions, label updates, CMC changes.
- Familiarity with regulatory impact assessments.
- Good documentation skills and attention to detail.
- Ability to work effectively with crossfunctional and global teams.
- Strong organizational, planning, and communication skills.
- Prior experience with regulatory databases or submissiontracking tools is an advantage.
Ideal Candidate Profile
- 5+ years of experience in Regulatory Affairs (Pharma).
- Understanding of EU regulatory requirements for pharmaceuticals.
- Experience in module preparation and lifecycle submissions.
- Ability to handle multiple projects and meet submission deadlines.
- Comfortable working in a fastpaced, compliancedriven environment.
