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

As a Regulatory Affairs Associate, you will be required to hold a Master's Degree in M. Pharm or M. Sc. with a specialization in Pharmaceutics, Industrial Pharmacy, Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, Biochemistry, or Microbiology. A minimum of 2 to 6 years of hands-on experience in R&D within Manufacturing or Import companies, specifically in MNCs and Generics, is essential for this role. Proficiency in CDSCO and Central Licensing Agency - New Delhi (SUGAM) skills, including Agency Liaison, is a priority as applications lacking these skills will not be considered. Your responsibilities will include understanding new client requirements, scope, deliverables, and timelines, reviewing and finalizing Gap Analysis Reports, effective collaboration and communication with internal and external stakeholders, technical writing of regulatory documents, liaison with licensing authorities such as CDSCO, training internal technical team members on the latest updates and guidelines, and coordinating with stakeholders. Key responsibilities will involve Regulatory Strategy, KOL/SME/Agency and Network-Access, Review of Documents/Dossiers and Gap Analysis, and Technical Writing of Regulatory Documents. This is a full-time position with a day shift from Monday to Friday, based in Bangalore (Cunningham Road), serving the Indian market for API and Finished Formulation. A willingness to travel up to 25% of the time is required, with a start date of 04/08/2025, and the application deadline is 07/07/2025.,