Job Information
Parexel Senior Regulatory Affairs Associate- Regulatory Affiliate in India
The role is responsible for supporting end‑to‑end regulatory life-cycle management activities for assigned products. This includes preparation and maintenance of global regulatory documentation, coordination of post‑approval changes, and ensuring compliance with national regulatory requirements. Coordination of transverse projects such as address changes impacting all local contacts.
Key Responsibilities
1. Preparation, Organization & Coordination of Local Regulatory Documentation
Prepare, compile, and review country‑specific 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 CMC‑related 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.
3. 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 cross‑functional and global teams.
Strong organizational, planning, and communication skills.
Prior experience with regulatory databases or submission‑tracking 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 fast‑paced, compliance‑driven environment.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.