General Manager - Regulatory - Pharma Formulation

General Manager - Regulatory - Pharma

- Review the DMF / Registration Dossiers / TDPs of in-house developed Formulations in US, EU & Emerging Markets for accuracy of data, regulatory adequacy and completeness &prepare responses to regulatory deficiencies for expeditious approval.

- Reviewing of DMF, GMP & Site accreditation documents for different countries and seek approval.

- Reviewing of process packages from CRD and audited for adequacy from regulatory point of view.

- Provide support to plant during time of audits of various Regulatory Agencies/customer.

- Keeping updates on regulatory requirements for submission of DMFs to regulatory authorities of various regions like US, EU, Japan, and Canada.

- Review of pertaining documents of initial submission, supplement and amendment submission and deficiencies response.

- Coordinate with R&D and Plant for drug product development/manufacturing, document generation and document correction.

- Vendor selection and approval system

- Coordinate with consultant for GMP inspection and drug product submission

- Conduct and facilitate internal audits and coordinate and manage external audit schedules

- Queries response to the regulatory agencies related with plant audits, correspondence and closing of findings

- Post graduate in Chemistry / B. Pharma in Analytical Chemistry with 15+ years in Regulatory functions from reputed -pharmaceutical industry (USFDA / WHO/ TGA / MHRAUK)

- Must have faced national/international audits in a leading role

- Self-driven, results-oriented with a positive outlook, and a clear focus on high quality and business profit.

- A natural forward planner who critically assesses own performance.

- Empathic communicator, able to see things from the other person's point of view.

- Keen for new experience, responsibility and accountability.

- Able to get on with others and be a team-player.

Interested candidates forward their updated resume to or call me on 8712767236