Job Location: Chennai
Role Description
This is a full-time on-site role for a Regulatory Specialist. The Regulatory Specialist will be responsible
for ensuring regulatory compliance, staying up-to-date with regulatory requirements, and utilizing
analytical skills to identify potential issues. The Regulatory Specialist will also be responsible for
communicating with regulatory agencies and providing regulatory affairs support to other teams.
Designation: RA Specialist (US-FDA)
Job Department: Regulatory Affairs
Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science
Regulatory Experience: Minimum 3 years in US FDA/ MDSAP/ 510 K submission
Industry/ Background – Medical Device /Pharma/Lifesciences Industry
Qualification: M Sc Life Science/ BTech Medical / B Pharm/ M Pharm
Employment Status: Permanent
Job Location: Chennai
Workplace Type: On-site
Minimum Requirements:
- Minimum of 2-3 years of experience in regulatory affairs Healthcare industry, with specific experience in USFDA / 510K submission and MDSAP Audit preparation.
- Understanding of cGMP and US FDA guidelines.
- Ability to effectively present information to management and other groups
- Experience in preparing and managing regulatory dossiers, including DMFs, INDs, MAAs, and
other regulatory submissions.
- Excellent understanding of pharmaceutical product development processes, manufacturing,
and quality control.
- Strong attention to detail and accuracy in documentation and data management.
- Effective communication and interpersonal skills, with the ability to collaborate with crossfunctional teams and interact with regulatory authorities.
- Proficiency in using regulatory affairs software, document management systems, and
- Microsoft Office Suite.
- Ability to multitask, prioritize workload, and meet tight deadlines in a fast-paced and
dynamic environment.
- Knowledge of international regulatory requirements and experience with Health Canada/
- Brazil/ Japan/ USFDA/ Australia regulatory submissions is a plus.
- Certification or training in USFDA/ Other Regulatory affairs is preferred
Roles and Responsibilities
- The candidate will be responsible for handling and following of Regulatory process of USFDA
/ 510 K Submission.
- Prepares eCTD filings for submission to the US Food and Drug Administration (US FDA) and
other global regulatory agencies.
- Review and interpret regulatory guidelines and communicate updates and changes to
internal stakeholders.
- Coordinate with cross-functional teams, including R&D quality assurance, and
manufacturing, to gather necessary information and documentation for dossier preparation.
- Collaborate with regulatory authorities and agencies to address queries, provide additional
information, and facilitate dossier review processes.
- Stay updated with evolving regulatory requirements and industry trends related to USFDA.
- Assist in the preparation and submission of post-approval regulatory filings, variations, and
renewal applications.
- Prepares all product listing, facility registration, product label updates, and facility
identification for submission to the US FDA.
- Support and coordinate for MDSAP / ISO 13485 / QMS Audits, Internal Audits, and
- Complaints and CAPA process.
- Responsible for verifying specification of excipients, active, finished product and packaging
material, and all required documents.
Send your resume to: [email protected]
