Regulatory Affairs Specialist (Mumbai)

Regulatory Affairs Specialist (Mumbai)

06 Aug
|
Rossari Biotech
|
Mumbai

06 Aug

Rossari Biotech

Mumbai

Role & responsibilities

Regulatory Compliance & Documentation

- SDS Management: Prepare, review, and maintain Safety Data Sheets (SDS) in strict compliance with global and regional hazardous communication regulations (e.g., GHS, OSHA, CLP).
- REACH Management: Act as the primary point of contact for REACH-related correspondence, managing inquiries and data exchange with customers, suppliers, and regulatory bodies.
- Declarations: Draft and issue accurate regulatory statements and customer compliance declarations (e.g., allergen statements, GMO status, country of origin) within established deadlines.
- Pharma Tech Packs: Author, compile, and organize comprehensive Pharma Tech Packs to support pharmaceutical product qualifications and regulatory filings.
- Backup Certification Support: Provide secondary support for specialized industry certifications, including RSPO (Roundtable on Sustainable Palm Oil) and OMRI (Organic Materials Review Institute).

Cross-Functional Support & Records Management

- Information Gathering: Coordinate closely with Quality, Technical, Sales, and Regulatory teams to retrieve product specifications, testing data, and raw material details.
- Document Control: Maintain immaculate document records,



ensuring strict version control and alignment with company standard operating procedures (SOPs).
- Supply Chain & Customer Support: Promptly resolve regulatory shipping queries and urgent customer documentation requests in coordination with the reporting manager to prevent customs or delivery delays.

Preferred candidate profile

Education & Experience

- Education: Bachelors degree in Chemistry, Biochemistry, Pharmacy, Environmental Science, or a related technical discipline.
- Experience: 4 to 6 years of experience in regulatory affairs, chemical compliance, or quality assurance within the chemical, pharmaceutical, or ingredient manufacturing sectors.

Technical & Soft Skills

- Robust working knowledge of global chemical regulations (GHS, REACH) and industry standards (OMRI, RSPO).
- Experience using SDS authoring software and chemical management databases.
- Exceptional attention to detail with proven experience managing version-controlled documentation.
- Strong communication skills to manage external correspondence with regulatory authorities and high-value customers.
- Ability to work under pressure to resolve supply chain blocks or meet strict customer SLAs.

📌 Regulatory Affairs Specialist (Mumbai)
🏢 Rossari Biotech
📍 Mumbai

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