Group Leader Regulatory Affairs - 6575
Location: Navi Mumbai, IN, 400706
Job Description :
- Lead a team that will prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards.
- Responsibility for MA compliance with both legislation and business needs.
- Ensure approvals are secured within the stipulated timelines for designated projects.
- Maintain registration documentation and associated electronic databases, in line with in-house procedures.
- Provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams.
- Prioritise, plan and monitor submissions for allocated procedures while documenting and informing involved parties of progress.
- Communicate with other Teva departments across Europe and European Agencies regarding proposed and pending submissions.
- Maintain and develop awareness of current/pending regulatory legislation and guidelines.
- Fulfilling other allocated department duties and ad-hoc needs at the direction of Senior Regulatory Affairs personnel.
- Perform all other job related duties as required by management
Qualifications : M Pharm / MSc or B Pharm