Regulatory Affairs Associate II
Navi Mumbai, India, 400706
We Are Teva
We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
How you’ll spend your day
- 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.
- Prioritise, plan and monitor submission for allocated procedures while documenting and informing involved parties of progress.
- To give regulatory support to project teams, stake holders and European Units for defined product responsibilities.
- Support the development and implementation of regulatory strategies for defined projects.
- 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.
- Support the defined processes within the department and provide input where improvements can be made.
- Awareness of current/pending regulatory legislation and guidelines
Your experience and qualifications
Required Degree: Master in Pharmacy or Master in science/life sciences
Experience:
- Relevant years of experience required for the role: 4 to 6 years in Regulatory affairs with EU post approval
- Overall Pharma industry experience: 4 to 6 years
- Desirable to have EU member state experience and knowledge of European regulatory procedures.
Knowledge:
- EU member state experience and knowledge of European regulatory procedures (Mutual Recognition, Decentralised and Centralised Procedures).
- CMC
- Change control process
- Understanding of processes and departments within a pharmaceutical company
How We’ll Take Care of You
At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.
Skills
- Excellent oral and written communication (English)
- Ability to work under pressure and to tight time deadlines
- Effective time and organisation management
- Negotiation
- Initiative
- Analytical (Data and Documentation)
- Computer literacy
- Presentation skills
Teva’s Equal Employment Opportunity Commitment
