Senior Manager

Serum Institute; Hadapsar; On-site; INR 4,000,000 - 8,500,000; Full time

Job summary

Serum Institute seeks a senior Regulatory Affairs professional to lead global submission strategies for IND vaccines and recombinant products. The role interfaces with Production-Managers and Corporate Regulatory Affairs to ensure alignment with USFDA, EMA, CDSCO requirements.

Ideal candidates have deep knowledge of ICH guidelines, QBD approaches, and sterile/biotech process validations, with 13–17 years of regulatory experience and strong English communication.

Qualifications

• Deep knowledge of regulatory requirements and quality systems in global markets (EU, UK, US, LATAM, Canada) for vaccines/biologicals.
• 13–17 years of regulatory affairs experience in IND vaccines/mAbs/recombinant products.
• Strong English writing and communication skills.

Responsibilities

• Coordinate regulatory submissions and variations with production teams.
• Ensure process parameters, batch records, deviations align with global regulatory commitments.
• Develop high-quality regulatory documents (DS/CTD, risk assessments, comparability) in scientific language.
• Respond to deficiencies/IRs from global health authorities within deadlines.
• Prepare and review regulatory dossiers and variations with production personnel.

Job description

Role & responsibilities

• Interaction within the Biopharmaceutical Manufacturing team, this high-impact technical role acts as the primary frontline interface and between Production-Managers and the Corporate Regulatory Affairs department.
• Ensure that all process parameters, technical batch records, engineering modifications, and manufacturing deviations strictly align with global regulatory commitments (USFDA, EMA, CDSCO) before documentation exits the facility, significantly eliminating compliance gaps and accelerating submission lifecycles
• Strategic inputs for regulatory approaches for licensure of INDs
• Develop high quality documents based on manufacturing process namely process, development report, risk assessments, product comparability, suitability etc.
• Understanding of scientist data and convert to good technical regulatory document in scientific language
• Technical Query Resolution: Coordinate directly with production supervisors & scientists to compile, draft, and technically justify responses to deficiencies or information requests (IRs) from global health authorities
• Preparation and review of regulatory dossiers and variations along with production personnel.
• General regulatory and maintenance tasks; provide feedback to R&D Director
• Query Management: CDSCO, USFDA, EMA. Coordinate responses to deficiencies clarifications and technical queries raised by regulators with in strict deadlines.
• Technical Knowledge: Deep understanding of biotech lifecycle guidelines, including ICH Q5 (A, B, C, D,E) for biological products, ICH Q7 (Active Pharmaceutical Ingredients), and standard cleanroom/sterile process validations.

Preferred candidate profile

In depth knowledge of regulatory requirement, regulatory process and quality systems in EU, UK, US, LATAM and Canada for Vaccines and Biologicals.

Sound technical knowledge of each stage of Biopharmaceutical processes, aseptic techniques, cGMP and hands on experience and expertise for 13-17 years in regulatory affairs specifically for IND vaccines/ mAbs /recombinant products

Command over English language and high proficiency in spoken on writing skill in English

Thorough understanding of ICH quality guidelines, QBD approach and EU Annex 1 etc, excellent knowledge of pharmaceutical quality systems change control, deviation, CAPA etc.