Job description
Job Title: Assistant Manager - Regulatory Affairs

Location: Navi Mumbai

Experience Required: Regulatory Affairs skilled 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 regula

📌 Assistant Manager (Navi Mumbai)
🏢 TechInvention Lifecare
📍 Navi Mumbai