AM/DM Regulatory Affairs API

Job description

We are seeking the AM/DM - Regulatory Affairs (API), who will be responsible for overseeing and coordinating all regulatory activities related to Active Pharmaceutical Ingredients (APIs) to ensure compliance with global regulatory standards. The role involves preparing, reviewing, and submitting regulatory documentation to health authorities and ensuring the companys APIs meet regulatory requirements across various regions.

Profile: Assistant Manager/Deputy Manager

Experience 9 + years

Location- Derabassi (Punjab) near to Chandigarh

CTC- As per industry norms

Job Responsibilities:

Regulatory Submissions:

Prepare, review, and submit regulatory documents for APIs, including:

• Drug Master Files (DMFs) – US DMF (Type II), EU CEPs, Canadian DMFs, and others.
• Registration dossiers as per region-specific requirements (e.g., CTD, eCTD formats)
• Coordinate with internal teams to compile technical data for submissions.
• Provide timely responses to health authority queries and deficiency letters.

Compliance & Documentation:

1. Ensure all APIs comply with global regulatory standards such as FDA, EMA, TGA, Health Canada, and ICH guidelines.
2. Maintain accurate and up-to-date regulatory documentation, including technical and quality-related information.
3. Oversee regulatory change management for APIs, ensuring compliance with variation guidelines.

Cross-Functional Collaboration:

1. Work closely with R&D, Quality Assurance, Quality Control, and Production teams to gather data and ensure regulatory compliance throughout the product lifecycle.
2. Provide regulatory guidance during the development of new APIs and during technology transfer activities.

Audits & Inspections:

1. Support regulatory agency inspections and customer audits by providing required documentation and ensuring compliance.
2. Address regulatory findings and implement corrective actions to mitigate compliance risks.

Strategy & Updates:

1. Stay updated on global regulatory requirements and communicate changes to internal stakeholders.
2. Develop regulatory strategies to support API product development and commercialization in key markets.

Qualifications and Experience:

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field.
• 8–12 years of experience in Regulatory Affairs, specifically in API.
• In-depth knowledge of API manufacturing processes and regulatory requirements.
• Experience with eCTD submission tools and software is preferred.