ClinChoice is a leading pharmaceutical organization dedicated to regulatory excellence and global healthcare innovation. With a strong focus on efficient product registration, timely approvals, and strict adherence to international standards, ClinChoice empowers its regulatory affairs team to make a significant impact on healthcare delivery worldwide. The Hyderabad office is a hub for managing complex regulatory submissions and ensuring product compliance across multiple regions including the EU and CIS.
Job Description: Regulatory Affairs Specialist
Key Responsibilities:
- Prepare and submit CMC modules (Modules 2 & 3) and post-approval regulatory filings.
- Support product launches and tender applications in compliance with regulatory requirements.
- Coordinate with health authorities to ensure full compliance with EU and CIS regulations.
- Review product formulations, claims, and labeling according to company SOPs.
- Manage project timelines and deliverables for regulatory submissions.
- Maintain documentation and ensure accuracy in e-CTD submissions.
Eligibility Criteria:
- Education: Degree in Chemistry, Pharmacy, or related fields (BPharm, MPharm, MSc Chemistry, MSc Pharmaceutical Sciences, Regulatory Affairs Certification preferred).
- Experience: Proven hands-on experience in CMC regulatory affairs and e-CTD documentation.
- Skills: Strong project management, communication, and coordination skills.
Location & Work Mode
- Location: Hyderabad, India
- Work Mode: Full-time, Work from Office
How to Apply
Interested candidates can apply by sending their updated CV to:
Email: saba.naaz@clinchoice.com
Make sure your CV highlights your experience in CMC regulatory affairs and e-CTD documentation to increase your chances of selection.
