Regulatory Affairs Manager

Preferably Injectables

Role & responsibilities

Working Days: 6

Team Management yes

Experience Min 12 + years

Designation Manager or Sr. Manager (Injectables)

This role reports to the Head Regulatory in a team lead position.

Exposure: Global Markets, US, Europe, ROW, Latam, APAC Etc.

Responsibility:

1. The role holder is responsible for planning and leading the assigned team for the execution of all activities related to review of executed important documents, compiled dossier, deficiency responses, post approval supplements & variations for global markets. Coordination with cross-functional teams for on-time completion of projects.

2. Execute regulatory team activities as directed to achieve quality submission and approval.

3. Maintain general knowledge of regulations and guidance for one or more product types (Injectables, API, etc.) within designated region (s).

4. Coordinate with stakeholders (R&D, Plant and suppliers) for sourcing of documents and review of executed documents received.

5. Plan, execute, and review assigned activities and ensure timely completion.

6. Support all regulatory activities associated with product development, new registration and life cycle management as per requests from clients.

7. Collaborate with the regulatory team to author submission documents for new submissions, deficiency responses and supplements/variations.

8. Collaborate with the regulatory team to ensure all documentation is in compliance with eCTD standards (meant for eCTD associates).

9. Review of the dossier in eCTD format and ensure its validation and submission for global markets.

10. Evaluate the change controls and adequate reporting through variation filing with adequate documentation. Report and escalate incidents in a timely manner as the situation demands.

11. Training and mentoring of the team members to keep abreast of the new guidance for the assigned markets.

12. Carry out activities as assigned by the immediate supervisor from time to time, for which he is authorized to perform as per the SOP

Preferred candidate profile

Bachelors or masters degree - M. Pharm / B. Pharma