Role & responsibilities

- Responsible for regulatory handling and providing guidance for submission, query response and variation activity to the team members
- Responsible for filings of MA applications for Canada / EU / Australia market. Preparation of checklist for documents required for initial submission for Canada / EU / Australia market
- Responsible for review of new projects documents for Canada / EU / Australia.
- Responsible for review of documents like specifications, MFC, MPR, Vendor documents and submission related documents
- Responsible for handling comments received from Regulatory Authority.
- Co-ordinate with various departments like Formulation and manufacturing plant for filing documentation/ customer query
- Provide dossier for online audit to concerned customers. Submitting response to due diligence and the proceeding activities.
- Coordination with API supplier for regulatory activities.
- Co-ordinate with Packaging development department for Product information and artwork preparation/ updation for recent/ approved products




- Co-ordinate with various consultants for activity related initial submission and query response.
- Responsible for change control review, approval and maintenance in particular folder.
- Updation of product approval status, monthly status, variation tracker, change control tracker etc.

Other responsibilities

- Maintenance of Documents, in particular Folder
- Maintain and follow-up of Invoice and entry of Invoice in Excel Sheet
- Preparation of list for pending payment and future invoices.
- Co-ordinate with account department to make sure that payment completed on time and avoid Penalties.
- eCTD uploading and submission
- EU lifecycle management

Preferred candidate profile

- Educational Qualification - B pharm / M pharm
- Minimum 8-10 years experienced candidate handling Canada / EU / Australia Countries.

Interested candidates can apply or mail their resume on [email protected]

📌 Regulatory Affairs Manager - Canada / Australia Market (Navi Mumbai)
🏢 Umedica Labs
📍 Navi Mumbai