Senior Manager

Talent Linked Consultancy

12 - 15 years

11 - 15 Lacs

Mumbai

Posted:6 days ago| Platform:

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Skills Required

Head Business Development Query resolution Pharma Project management qaqc Strategic planning GMP Management Strategy development Regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

To Support developing strategies to enter the market for the products in EU , Canada, Australia, Brazil etc.
Independent supervision of all regulatory activities regarding dossier review, compilation, submission, approval and lifecycle management of the assigned products.
Compilation and maintenance of regulatory documents in the supported business areas;
Representation of Regulatory Affairs for SRA countries especially with regard to the regulatory requirements;
Co-ordination with the CFT (QA/QC/RND/BD) team members to align the requirements and get it work done smoothly.
Problem solving and strategic planning mindset are essential skills for this role with project management skills for collaborating with the BDMs in an entrepreneurial, fast-paced company environment
Total Experience : 12 to 15 Yrs preferably in injectable, SOD with a knowledge of GMP.
Extensive knowledge of regulatory requirements, but also GMP guidelines, enable to find constructive solutions for sometimes complex issues
Characterized by high quality awareness paired with practicality and solution-oriented thinking, as well as flexibility and perseverance
Exposure in Regulatory approved companies from EU, Health Canada, TGA ANVISA, WHO, FDA etc.
Expected Output (Quantitative/Qualitative) from the role in current or next 1 year

Master Dossier compilation, Query resolution

Support Business
development team by getting on time registrations

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