Job Title: Assistant Manager - Regulatory Affairs

Location: Navi Mumbai

Experience Required: Regulatory Affairs professional with 5–6 years of experience in the vaccine industry, with strong expertise in regulatory processes, submission requirements, and product lifecycle management. Experienced in developing and executing regulatory strategies and managing submissions in alignment with national (CDSCO) and global regulatory standards (FDA, EMA, WHO, and other health authorities).

Job Summary

We are looking for an experienced Regulatory Affairs Manager to manage and coordinate all regulatory activities related to our vaccine products. This role requires strong knowledge of regulatory requirements, submission processes, and compliance within the vaccines industry. The ideal candidate will ensure our products meet the necessary regulatory standards for local and international markets, supporting our commitment to bringing high-quality vaccines to market efficiently.

Key Responsibilities

· Manage and oversee regulatory submissions, approvals, and communications with national and international health authorities for vaccine products.

· Ensure compliance with local, regional, and international regulatory requirements, guidelines, and standards applicable to vaccines.

· Prepare, compile, and submit regulatory dossiers including New Drug Applications (NDAs), Marketing Authorisation Applications (MAA), renewals, and post-approval submissions for vaccine products.

· Prepare and maintain CTD/eCTD dossiers for in-house R&D; vaccine products, in-license products, ensuring accuracy, completeness, and alignment with regulatory requirements.





· Provide regulatory support for clinical trials of vaccines, including preparation and review of Clinical Trial Applications (CTA), clinical trial protocols, Investigator’s Brochure (IB), informed consent forms (ICF), Clinical Study Reports (CSR), and related regulatory documentation.

· Develop and implement regulatory strategies for vaccine development, clinical trials, and product registration to facilitate timely approvals and market access.

· Stay up-to-date with evolving vaccine regulatory guidelines, policies, and industry standards and ensure ongoing compliance.

· Liaise with regulatory authorities to address queries, facilitate regulatory reviews, and ensure a smooth approval process for vaccine products.

Qualifications

· MSc in Regulatory Affairs, Pharmaceutical Sciences, Life Sciences, or related fields

· Additional certifications in regulatory affairs will be an advantage

Skills Required

· Strong understanding of vaccine regulatory requirements and compliance frameworks

· High level of accuracy, attention to detail, and documentation management

· Ability to interpret regulatory guidelines and apply them effectively in practice

· Proficiency in regulatory submission tools and Microsoft Office applications

· Effective communication and coordination with regulatory authorities and cross-functional teams

· Robust project management skills with the ability to handle multiple priorities and timelines

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? Send your CV to [email protected] and [email protected]

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📌 Assistant Manager - Regulatory Affairs (Navi Mumbai)
🏢 TechInvention Lifecare
📍 Navi Mumbai