Senior Regulatory Affairs Associate- Regulatory Affiliate
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
The role is responsible for supporting endtoend regulatory lifecycle management activities for assigned products in the local market. This includes preparation and maintenance of countryspecific regulatory documentation coordination of postapproval changes and ensuring compliance with national regulatory requirements. The position also supports audits/inspections and collaborates with crossfunctional teams (Quality Supply Chain Pharmacovigilance Medical Commercial) to maintain regulatory compliance.
Key Responsibilities
1. 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 new registrations renewals variations PSURs/PBRERs safety updates label updates and CMCrelated changes.
- Maintain and update local regulatory databases (VEEVA RIMS) tracking systems and product registration archives to ensure compliance with local legislation.
- 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.
2. Provide Local Input for PostApproval Changes & Change Control
- Evaluate change control notifications related to manufacturing quality safety or labelling changes and provide countryspecific regulatory impact assessments.
- Work with global/regional RA Quality and Supply Chain teams to ensure timely implementation of postapproval changes as per national regulatory timelines.
- Prepare and submit variation dossiers or notifications based on local regulatory classifications and guidelines.
- Track approval timelines and ensure that all regulatory commitments arising from changes are fulfilled promptly.
3. Support in Audits Inspections & Regulatory Compliance
- Support the local RA representative during internal audits external audits and health authority inspections.
- Coordinate and prepare documentation required for inspections ensuring readiness of RA records and systems.
- Assist in responding to audit observations and regulatory findings.
- Collaborate with crossfunctional teams to ensure timely closure of Corrective and Preventive Actions (CAPAs).
- Ensure continuous compliance with evolving national regulations and proactively identify potential risks.
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 change control processes and 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
- 4 years of experience in Regulatory Affairs (Pharma or Biologics).
- Understanding of Indian 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.
Required Experience:
Senior IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
