About the Role:
As a Site Regulatory Associate, you will be responsible for authoring and maintaining Chemistry, Manufacturing, and Controls (CMC) documentation to support global and local regulatory submissions. You will collaborate closely with global and country Regulatory Affairs (RA) teams, ensuring timely filings, managing regulatory queries, and assessing the impact of manufacturing and quality changes. This role is critical in bridging site operations with global regulatory strategies, ensuring compliance while enabling innovation.
Key Responsibilities :
- Author and review CMC sections of regulatory dossiers
- Support new product filings, variations, renewals, and lifecycle management submissions.
- Partner with global RA teams to align submission strategies and timelines.
- Coordinate with country RA affiliates to meet local regulatory requirements.
- Manage responses to Health Authority queries, liaising with site experts and QA.
- Conduct regulatory impact assessments for site changes and support change control processes.
- Maintain compliance with evolving global regulatory guidelines (ICH, EMA, FDA, PMDA, WHO).
- Support audits and inspections with regulatory documentation and expertise.
- Drive continuous improvement in submission processes and site regulatory compliance.
Skills & Competencies :
- Strong knowledge of global CMC regulatory requirements and guidelines.
- Excellent technical writing and documentation skills.
- Ability to interpret complex technical data and translate into regulatory language.
- Strong collaboration and communication skills across global and local teams.
- Proficiency in regulatory submission systems (eCTD tools, Veeva Vault, or similar).
- Analytical mindset for change impact assessments and risk evaluation.
- Ability to manage multiple projects under tight timelines.
Qualifications :
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or Life Sciences.
- 10 + years of experience with recent 3-5 years in Regulatory Affairs (CMC focus) within the pharmaceutical industry.
- Experience with global regulatory submissions and country-specific filings
- Familiarity with manufacturing processes, quality systems, and GMP requirements.
