Assistant Manager/Sr. Executive - Regulatory Affairs

Job Description:

We are looking for a Senior Executive / Assistant Manager in Regulatory Affairs to manage regulatory submissions for Sterile Formulations (i.e., Liquids / Emulsions / Lyophilised / Pre-Filled Syringes / Ophthalmics). This role works closely with cross-functional teams to support product development and commercialization in global markets.

Key Responsibilities:

• Oversee the preparation, submission, and management of regulatory dossiers, including eCTD submissions, for sterile formulations inclusive of drug-device combination products across international markets.
• Ensure continuous compliance with global regulatory requirements (US, EU, and other international markets) throughout the product lifecycle.
• Conduct regulatory impact assessments and risk evaluations to anticipate and mitigate potential compliance issues.
• Work closely with R&D, Quality Assurance, Manufacturing, and Marketing teams to support product development and commercialization strategies.
• Review and approve labelling, promotional materials, and other regulatory documents to ensure accuracy and compliance with regulatory standards.
• Stay updated on evolving global regulatory requirements and provide strategic guidance on regulatory changes that may impact products.
• Prepare for and support regulatory inspections and audits, ensuring readiness and compliance during regulatory authority reviews.

Required Experience, Qualification and Skills

• M.Sc. / M Pharma with 5 to 10 years of proven experience in regulatory affairs, with a focus on sterile formulations..
• Strong understanding of global regulatory requirements, particularly for US (FDA), EU (EMA), and other major markets
• Proficiency in eCTD submission platforms and electronic regulatory filing systems.
• Experience with regulatory submissions for medical devices, biologics, or pharmaceuticals.
• Excellent written and verbal communication abilities, with attention to detail.