Macleods, India’s Fastest growing pharmaceutical company, with a strong R&D and own Bio-equivalence centre, manufacturing sites approved by USFDA & WHO Geneva, ranked among the top pharmaceutical companies with a strength of more than 10,000 employees, presently operating in more than 50 countries worldwide.
Macleods Pharmaceuticals Recruiting For Following:
- Qualification: M.Pharma
- Experience : 15-20+years
- Department: Regulatory Affairs
- Designation: Sr Manager
- Job Location: Mumbai Suburban,Maharashtra
- No.of Openings: 01
Interested candidates can share their updated resume to [email protected]
Job description:
We are looking for Sr Manager – Regulatory Affair – Global Team & MENA Region at Macleods Pharma
Designation : Sr Manager – Global Team of Cardiovascular Products & MENA region
Qualification : M.Pharma
Experience : 15 – 20 Years
Location : Andheri East
Job Description
Ensure preparation and submission of registration dossier, query responses, renewal application, variation application as per pre-define timeframe for MENA Market.
Arranging and finalizing responses on deficiencies raised by regulatory agencies on submitted application.
Ensure preparation of global dossiers and updating global dossier sections for query responses, renewals, and variations.
Review of the technical documents for products which are under development, filing and commercialized.
Review and approval of technical documents from R&D and manufacturing unit.
Review of initial and updated Approval packages based on approvals.
Coordination and follow-up with respective Regulatory Agencies/Customers/Business partners for Dossier, query responses, variation and renewal submissions.
Coordination with manufacturing unit for getting supporting data required for submission of new application, query responses, renewal procedure and variation applications.
Co-ordination with different department such as F&D, ARD, BE department, Business department for getting supporting data required for submission.
Training of the team members for submissions, product life cycle management, maintain and archival of internal database.
