Regulatory Affairs Specialist - CMC-Chemical/Biological

Education – Masters Degree is a must

with Minimum hand-on experience of 2 to 6 years in: R&D (Manufacturing or Import) Companies

1. MNC

2. Generics

M. Pharm - Pharmaceutics/Industrial Pharmacy/Pharmaceutical Chemistry/Analytical Chemistry or any Chemistry combination

M. Sc., (Life Sciences) - Chemistry, Biochemistry, Microbiology

Skill Priority: CDSCO, Central Licensing Agency - New Delhi (SUGAM) including Agency Liaison

applications without the above skill will not be considered

Location - Bangalore (Cunningham Road)

Market - India (Import and Market – API and Finished Formulation)

Job Responsibilities -

1. Understanding new client requirements, scope, deliverables as well as timelines.

2. Reviewing of documents/documents and finalizing Gap Analysis Reports & Responding to queries

3. Effective collaboration and communication both written and verbal among internal/external stakeholders

4. Technical Writing of Regulatory documents

5. Liaison with various licensing authorities and agencies like CDSCO etc.

6. Effectively training internal technical team members on the latest updates and revisions to guidelines.

7. Communication and coordination with internal and external stakeholders

Key Responsibilities -

· Regulatory Strategy

· KOL/SME/Agency and Network-Access

· Review of Documents/Dossiers and Gap Analysis

· Technical Writing of Regulatory Documents

Job Type: Full-time

Pay: ₹600,000.00 - ₹1,200,000.00 per year

Schedule:

• Day shift
• Monday to Friday

Ability to commute/relocate:

• Bengaluru, Karnataka: Reliably commute or planning to relocate before starting work (Required)

Experience:

• total: 2 years (Required)

Location:

• Bengaluru, Karnataka (Preferred)

Willingness to travel:

• 25% (Required)

Work Location: In person

Application Deadline: 07/07/2025
Expected Start Date: 04/08/2025