AM/DM

Regulatory Submissions:

1. 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).
2. Coordinate with internal teams to compile technical data for submissions.
3. 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.