Regulatory Manager

Job Title: Regulatory Affairs Head / Manager API Division

Department: Regulatory Affairs

Industry: Pharmaceuticals Active Pharmaceutical Ingredients (API)

Location: Andheri East

Experience Required: 815 Years (API Regulatory Affairs)

Qualification: M.Pharm / B.Pharm / M.Sc (Chemistry / Pharmaceutical Sciences)

Salary Up to 1Lakhs per Month

Job Purpose:

To lead and manage the Regulatory Affairs department for API products, ensuring compliance with global regulatory requirements and facilitating product registrations, dossier submissions, and approvals across domestic and international markets.

Key Responsibilities:

Regulatory Strategy & Compliance:

Develop and implement regulatory strategies for global markets (US, EU, WHO, ROW, AFRICA , ASIA , MIDDLE EAST, LATAM , CIS And emerging markets).

Ensure compliance with local and international regulatory guidelines (ICH, FDA, EMA, CDSCO, etc.).

Maintain up-to-date knowledge of regulatory changes and assess their impact on company operations.

Dossier Preparation & Submission:

Oversee preparation, review, and submission of DMFs (USDMF, EDMF, CEP, etc.), technical dossiers, and product registration files.

Manage deficiency responses, updates, and renewals of submitted dossiers.

Ensure timely filing of amendments, variations, and annual reports.

Regulatory Communication & Liaison:

Act as a key contact with regulatory authorities, clients, and certification bodies.

Handle customer queries, audits, and technical documentation requirements related to APIs.

Documentation & Quality Support:

Coordinate with QA, QC, R&D, and Production teams to ensure regulatory readiness and compliance.

Review specifications, stability data, validation reports, and other technical documents for regulatory submissions.

Maintain a robust document control and archival system.

Team Leadership:

Lead, mentor, and train the regulatory team for continuous improvement and professional development.

Drive cross-functional collaboration to ensure smooth and compliant regulatory operations.

Key Skills & Competencies:

In-depth understanding of global API regulatory frameworks (USFDA, EMA, TGA, WHO, etc.)

Strong experience in DMF preparation, dossier compilation, and life cycle management

Excellent communication and liaison skills with regulatory bodies and customers

Attention to detail, strong analytical and problem-solving skills

Proven leadership and team management capabilities

Preferred Experience:

Experience in filing and maintaining USDMFs / EDMFs / CEPs for APIs

Exposure to audits by international regulatory agencies

Experience in managing customer regulatory queries and updates

Understanding of QbD, ICH, and cGMP guidelines