Executive /Sr. Executive - Canada / Australia

Umedica Labs; Navi Mumbai; On-site; INR 600,000 - 900,000; Full time

Job summary

Umedica Labs in Navi Mumbai seeks a candidate with a background in pharmacy for a role focused on regulatory filings in Canada, EU, and other markets. The position requires 5-6 years of relevant experience and proficiency in handling submissions and documentation.

Responsibilities include preparing checklists, coordinating with various departments, and maintaining documentation. Interested candidates can apply via email.

Qualifications

• Minimum 5 to 6 years experience handling Canada / EU / Australia / UK markets.

Responsibilities

• Responsible for filings of MA applications for various markets.
• Coordinate with various departments for filing documentation.
• Handle comments from Regulatory Authorities.

Education

M.Pharm

B.Pharm

Job description

Role & Responsibilities

• Responsible for filings of MA applications for Canada / EU / Australia / UK market
• Responsible for preparation of checklist for documents required for initial submission for Canada / EU / Australia / UK market
• Responsible for review of new projects documents for Canada / EU / Australia / UK
• 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 new/ 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 - M.Pharm or B.Pharm
• Minimum 5 to 6 years experienced candidate handling Canada / EU / Australia / UK Countries.

Application Instructions

Interested candidates can apply or share their resume on [e-mail]