Walk-in || Regulatory Affairs Executive At PSA Chemicals And Pharmaceuticals
Time and Venue
- 14th August – 23 August , 9.30 AM – 6.00 PM
- Vashi, Navi Mumbai
- Contact – Dr Navneet Gadge ( 8591920365 )
REGULATORY AFFAIRS EXECUTIVE FDA LIAISONING
- Position: Regulatory Affairs Executive
- Department: Regulatory Affairs
- Number of Positions: 01
- Location: Head Office
- Reporting To: Head – Regulatory Affairs
- Experience: Minimum 4 Years
- Industry: Pharmaceutical – Finished Formulations
1. JOB PURPOSE
To support and manage regulatory activities related to pharmaceutical finished formulations, including preparation, submission, follow-up and maintenance of regulatory dossiers and effective liaisoning with FDA/Drug Regulatory Authorities, consultants, agents and internal departments for timely regulatory approvals and compliance.
2. KEY RESPONSIBILITIES
A. Regulatory Affairs – General
- Prepare, review, compile and maintain regulatory dossiers for pharmaceutical finished formulations.
- Coordinate preparation of regulatory submissions in accordance with applicable country-specific requirements.
- Review product information, formulations, specifications, manufacturing processes, packaging materials, artworks and supporting documents for regulatory compliance.
- Coordinate with QA, QC, Production, R&D, Supply Chain and other departments for collection of regulatory documents.
- Maintain regulatory submission trackers, approval status, commitments and renewal calendars.
- Prepare responses to regulatory queries, deficiencies and clarification letters under the guidance of the Head – RA.
- Maintain proper regulatory records and submission archives.
B. FDA / Regulatory Authority Liaisoning
- Coordinate and liaise with FDA/State FDA/Drug Regulatory Authorities and other competent regulatory authorities, as applicable.
- Follow up on applications, licenses, registrations, variations, permissions, renewals, NOCs and other regulatory matters.
- Coordinate with regulatory consultants/agents and authorized representatives for regulatory submissions and follow-up.
- Prepare and coordinate responses to observations, queries and deficiencies received from regulatory authorities.
- Track regulatory commitments and ensure timely submission of required responses/documents.
- Assist in scheduling and coordination of regulatory inspections, meetings and official communications.
- Maintain records of regulatory correspondence and interactions with authorities.
C. Product Registration & Dossier Management
- Support preparation and submission of dossiers for new product registrations, renewals, variations, post-approval changes and other regulatory applications.
- Review CTD/eCTD or country-specific dossier requirements, as applicable.
- Coordinate compilation of administrative, technical, quality and manufacturing documents.
- Ensure consistency of information across dossiers, certificates, labels, cartons, package inserts and other regulatory documents.
- Monitor product registration validity and initiate renewal activities within defined timelines.
D. Regulatory Documentation
- Coordinate documents such as:
- Manufacturing Licenses
- GMP/WHO-GMP/Eu-GMP Certificates
- CPP/COPP and FSC
- Certificate of Analysis
- Product Specifications
- Stability Data
- Validation Documents
- Site Master File
- Product dossiers
- Artwork and labeling documents
- Free Sale/Export Certificates
- Regulatory declarations and undertakings
- Ensure documents are current, properly controlled and suitable for regulatory submission.
E. Export & International Regulatory Support
- Provide regulatory support for pharmaceutical product exports to international markets.
- Coordinate country-specific regulatory requirements with overseas customers, agents and consultants.
- Support preparation of documents required for product registration, export approvals, NOCs, legalization/apostille and regulatory submissions, as applicable.
- Maintain country-wise regulatory trackers and product registration status.
- Assist commercial/business development teams with regulatory information required for new market/product opportunities.
F. Internal Coordination
- Coordinate with QA/QC, Production, R&D, Supply Chain, Commercial and Management for regulatory requirements.
- Review regulatory impact of proposed changes in formulation, manufacturing process, specifications, packaging and labeling.
- Communicate regulatory requirements and timelines to concerned departments.
- Escalate critical regulatory issues and delays to the Head – RA.
3. FDA LIAISONING – SPECIFIC ROLE
The incumbent shall be responsible for professional and documented coordination with FDA/competent regulatory authorities, including:
- Application submission and status follow-up.
- Coordination for manufacturing/product permissions and regulatory approvals.
- Regulatory query and deficiency management.
- Coordination for inspections and regulatory meetings.
- Follow-up for licenses, certificates, NOCs and permissions.
- Maintaining regulatory correspondence and submission records.
- Coordination with authorized consultants/agents where required.
Note: All regulatory authority interactions shall be conducted strictly within the authorization and instructions provided by Management/Head – RA and in accordance with applicable laws, regulations and company procedures.
4. QUALIFICATION
Essential:
- B.Pharm / M.Pharm / Pharm.D / equivalent pharmaceutical qualification.
Preferred:
- M.Pharm / MBA / PG Diploma in Regulatory Affairs or equivalent qualification.
5. EXPERIENCE
- Minimum 3 years of relevant experience in Pharmaceutical Regulatory Affairs.
- Experience in finished formulation regulatory submissions and FDA liaisoning is strongly preferred.
- Experience with international markets, product registrations and export regulatory documentation will be an added advantage.
6. REQUIRED KNOWLEDGE & SKILLS
- Good knowledge of pharmaceutical regulatory requirements and dossier documentation.
- Working knowledge of CTD/eCTD and country-specific registration requirements.
- Practical experience in regulatory authority correspondence and follow-up.
- Strong documentation and analytical skills.
- Good command of MS Word, MS Excel, PowerPoint and email communication.
- Excellent written and verbal communication skills.
- Ability to coordinate effectively with multiple departments and external stakeholders.
- Strong follow-up skills with ability to meet regulatory timelines.
- High level of accuracy and attention to detail.
- Ability to maintain confidentiality of regulatory and business information.
7. KEY PERFORMANCE INDICATORS (KPIs)
- Timely preparation and submission of regulatory applications.
- Timely response to regulatory queries/deficiencies.
- Effective follow-up with regulatory authorities and consultants.
- Accuracy and completeness of regulatory dossiers.
- Timely renewal of licenses and product registrations.
- Proper maintenance of regulatory records and trackers.
- Compliance with regulatory submission timelines.
- Effective coordination with internal and external stakeholders.
8. PERSONAL ATTRIBUTES
- Professional and responsible approach.
- Strong ownership and follow-up capability.
- Good interpersonal and liaisoning skills.
- Ability to work independently and under deadlines.
- Organized and detail-oriented.
- Ethical conduct and strict confidentiality.
- Willingness to travel for regulatory meetings/inspections, whenever required.
9. CONFIDENTIALITY & COMPLIANCE
The employee shall maintain strict confidentiality of all regulatory, technical, commercial and company information and shall comply with applicable regulatory requirements, company SOPs, policies, quality systems and instructions issued by Management.
10. GENERAL
The above responsibilities are indicative and not exhaustive. Management may assign additional responsibilities related to Regulatory Affairs, regulatory compliance, product registration, FDA liaisoning and other activities commensurate with the position and organizational requirements.
