Manager

We are hiring !

Job Title: Regulatory Affairs - UK/EU/AU/NZ/CA regions

Location: Dholka, Near Ahmedabad, Gujarat

Qualification: M. Pharma/B. Pharma

Job Type: Full-Time

Company: Cadila Pharmaceutical Ltd.

About Us: Cadila Pharmaceuticals Ltd, is one of the Largest Privately- held Pharmaceuticals companies in India. Over the past seven decades, We have been developing and manufacturing affordable medicines for the patients around the world.

Our innovation- led drug discovery processes ensure the health and well-being of people around the world. Our enhanced investment in innovation and strong track record in research and development have produced medical miracles that have changed lives and made a profound impact on real life.

Being a care-focused, research-driven company, we are committed to complying with the highest ethical standards in the clinical research and medical practice. We lead our industry in demonstrating the application of cutting edge research to ethical business practices in producing the alchemy of optimum health outcomes for all.

Job 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.