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Teva Assoc Dir Regulatory Affairs India, Karnataka, Bengaluru 786818705
Today
How you’ll spend your day
- Accountable to support all activities related to Regulatory Life Cycle Management activities in Worldwide Markets (EU, US, Other Markets: CMC Variations, Renewals, PSUR, RMP, safety variations etc)
- Hiring, Training and Retention of Staff in the team
- Work closely with Worldwide markets, assesses dossier suitability and creates a submission tracker for all assigned products to ensure appropriate planning and prioritization.
- Work closely with global regulatory teams in the EU/US/Other International Markets to support Life Cycle Management activities within Regulatory Affairs
- Coordinate responses to Health Authorities, with appropriate personnel and departments to resolve outstanding regulatory issues.
- Ensure that cross-functional activities to support submissions and works collaboratively with Market RA to ensure all requirements are met and dossiers are submitted as per the submission plan.
- Establish vision for the team, team building activities, planning and prioritization of daily work and regular business updates to management.
Your experience and qualifications
- B. Pharmacy/M. Pharmacy/MSc/Ph.Din Biology/Chemistry
- Experience: 12 to 15 years in RA
- Expertise in global regulatory strategies and life cycle management activities for Worldwide Markets
- Ability to work proactively and independently in a global environment
- Ability to plan, organize and execute projects as required within Global Regulatory Affairs
- Strong Leadership Experience with ability to build a collaborative environment within the team with positive work culture and develop junior staff members.
Personal Characteristics
- Good leadership, project management and communication skills
- Excellent analytical, problem-solving, and self-learning skills.
- Ability to work independently and effectively in a cross-functional team environment;manage multiple projects simultaneously.
- Detail-oriented with a high level of accuracy in work deliverables.
- Strong organizational and time management skills.
- Excellent spoken and written English is essential.
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