Assoc Dir Regulatory Affairs
Date:
Jun 20, 2025
Location:
Bangalore, India, 560064
Company:
Teva Pharmaceuticals
Job Id:
62543
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
This is a senior position within the regulatory team supporting the International Markets business unit. The individual will be responsible to lead and proactively manage a team of Regulatory Managers who work on regulatory life cycle management activities for a mature innovator portfolio covering EU, US and other International Markets. This is a leadership position that is accountable for hiring, training and retention of regulatory staff in the team in alignment with the objectives of the Global Regulatory Organization. The Lead is also involved in continuous improvement and looking at new tools/technologies to improve efficiencies in ways of working.
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.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
