Regulatory Affairs Assistant Manager

Job Description:

1. New submissions:

a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy.

2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency.

3. Lifecycle management for drug formulations:

a. Prepare and review variation , Annual notification and labelling approval for US and OAM

b. Review of change control and file variation as per country requirement

4. Regulatory compliance:

a. eCTD compilation

b. Ensure reposition of comprehensive product information into central repository

C. Review regulatory filing impact of variations, change controls, etc.

Review of CTD dossiers , variations, change controls, renewals and ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.

Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.

Master’s degree in Pharma

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7 to 10 years’) or equivalent combination of education, training, & experience.

• Strong technical skills in data analysis and interpretation of regulatory documentation.
• Excellent interpersonal and problem-solving skills with a proactive and solution-oriented approach.
• Effective negotiation and communication skills for liaising with internal teams and external agencies.
• Proficient in drafting and reviewing documents in line with global, regional, and national regulatory standards.
• Expertise in document management systems and tools like Excel, Outlook, PowerPoint, and Word.
• Strong presentation and reporting skills with the ability to explain complex regulatory concepts clearly.
• Demonstrated ability to analyze data systematically, apply regulatory logic, and compile well-organized submissions.
• Collaborative, results-driven, and self-motivated with the flexibility to adapt to shifting priorities.
• Capable of delivering high-quality outputs under pressure and within aggressive timelines.

share your resume at hrsupport@prgpharma.com

Job Type: Permanent

Pay: ₹450,000.00 - ₹500,000.00 per year

Work Location: In person