Manager

Job Opening: Regulatory Affairs Manager (10–15 Years Experience)

Location: Dholka, Near Ahmedabad, Gujarat

Industry: Pharmaceuticals

Qualification: B. Pharma / M. Pharma

Experience: 8–12 Years in Regulatory Affairs UK/EU/AU/NZ/CA regions

Responsibilities

- Compilation, review and submission of eCTD dossiers, renewal applications, variations, site transfer projects, post marketing applications and any other relevant submissions for UK/EU/AU/NZ/CA regions.

- Preparation of deficiencies responses for applications in the ICH region.

- Timely initiation and discussion with cross functional teams for necessary document required for preparation and submission of new/query response etc.

- Collaborative discussions with clients for ongoing regulatory submissions.

- Review and approve technical documents from cross functions related to registrations/submissions/variations

- documents like spec/STPs, protocols/reports, MMD-I, labelling/art work etc., as required.

- Initiation of change controls and review of change controls/deviations for ongoing projects as required.

- Review and approval of SAP orders, MMD-II and MDM.

- Tracking and maintenance of the regulatory database and project trackers including defined action points and target timelines.

- Attend required technical meetings with cross-functional teams for any submission/variation related needs, as and when required.

- Arrangement of samples/impurities/working standard/reference standard and dispatch to client as required.

- Track regulatory guidelines, regulatory forums and agency website on regular intervals.

Qualifications

• B. Pharm /M. Pharm or experience (10 to 15)