Senior Manager - RA (Europe)

Job Description

Role :   Sr. Manager – SRA (EU+ Canada+Australia+Brazil)

Reporting to :   Head RA

Location : Andheri, Mumbai

Experience :  12 to 15 years

Education :   M.Pharma / MS.c

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

Requirements

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