Manager (Regulatory Affairs)
JOB DESCRIPTION
Position title
Manager (Regulatory Affairs)
Location
Mumbai (Andheri) but will involve travel to manufacturing locations
Compensation + Perks
Competitive and at par with industry standardsDepartment
Regulatory Affairs
Reports to
Director or as designated by him
BRIEF OVERVIEW OF THE POSITION
As Regulatory Affairs Manager, you are responsible for ensuring that all products and processes comply with national and international regulations, laws, and standards. This role is crucial for maintaining legal compliance, facilitating product approvals, and protecting public health and safety.
JOB DESCRIPTION
1. Prepare, review, and submit regulatory documents and applications for product approvals, registrations, and licenses.
2. Ensure all submissions are accurate, complete, and meet regulatory requirements.
3. Maintain compliance throughout the product lifecycle by monitoring changes in regulations and updating processes as needed.
4. Generate SDS as per company requirements.
5. Maintain familiarity with the company’s current and future products.
6. Keep up to date with changes in regulatory legislation and guidelines.
7. Analyze complex information, including trial data.
8. Have knowledge of requirements for labeling, storage, and packaging of chemicals.
9. Serve as the primary point of contact with regulatory agencies, representing the company in meetings, negotiations, and during audits or inspections.
10. Write comprehensible, user-friendly, and clear product information leaflets and labels.
11. Oversee the organization and management of regulatory files, records, and documentation to ensure traceability and compliance with both domestic and international regulations.
12. Fill chemical compliance questionnaires and product safety and regulatory affairs forms provided by customers/third parties.
13. Communicate regulatory information and updates to multiple departments, ensuring correct interpretation and implementation.
14. Familiarity with CAS (Chemical Abstract Service Registry Number) and Harmonized System of Nomenclature (HSN Code expertise).
EDUCATIONAL QUALIFICATION & EXPERIENCE
1. Strong knowledge of QHSE practices.
2. Strong knowledge about ISO 9001, ISO 14000, ISO 45001, GMP.
3. In-depth knowledge in GHS/CLP/OSHA harmonized classification, SDS label preparation as per GHS; REACH (Global) regulations, EPA/TSCA/PSR requirements, DG Regulations, etc.
4. In-depth knowledge of core regulatory functions.
5. Proficiency in operating MS Office (Word, Excel, PowerPoint, etc.) and fluency in English to coordinate with international customers.
Please note that the above Job Description is only a guideline, the expectations from the position may be revised as per directives from the Management.
