Senior Manager - RA (Europe)
Senior Manager - RA (Europe)
Posted on :
08-07-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Role: Sr. Manager SRA (EU CanadaAustraliaBrazil)
Reporting to: Head RA
Location: Andheri Mumbai
Experience: 12 to 15 years
Education: / 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
- Master Dossier compilation Query resolution
- Support Business development team by getting on time registrations
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
Education
Education: / MS.c
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
