25 Aug
|
Teva Pharmaceuticals
|
Navi Mumbai
25 Aug
Teva Pharmaceuticals
Navi Mumbai
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.
The Opportunity The Senior Compliance Manager, Global Regulatory Operations is responsible for ensuring a robust and compliant regulatory quality framework across the Regulatory Affairs (RA) organisation. This role has primary accountability for audit management, regulatory deviations, and the end‑to‑end CAPA process, leveraging the Veeva Quality suite to drive transparency, inspection readiness, and continuous improvement.
The role acts as a key interface between Regulatory Affairs, Quality, and Global Regulatory Operations, ensuring regulatory processes meet global health authority expectations and internal quality standards.
The Manager / Senior Compliance Manager needs to have a good understanding of Global Regulatory Affairs processes with a solid Compliance background, will have a good understanding of Veeva GxP or other audit / CAPA system.
How You’ll Spend Your Day
Audit & Inspection Readiness
- Lead preparation, coordination, and execution of internal audits
- Coordinate any responses for any inspections relating to Regulatory Affairs activities.
- Serve as the one of the Global RA audit point of contact, ensuring consistent messaging, timely responses, and high‑quality documentation.
- Author, review, and manage audit responses and commitments within Veeva, ensuring accuracy, traceability, and adherence to timelines.
- Track all audit observations, trends, and metrics for Global regulatory Affairs.
Deviations & CAPA Management
- Assist with the ownership and maintain the Regulatory Affairs deviation and CAPA framework, including governance, SOPs, and templates.
- Ensure timely identification, investigation, documentation,
and closure of regulatory deviations.
- Lead root cause analyses and ensure effective, sustainable CAPAs are developed and implemented.
- Drive consistency and quality of deviation and CAPA records within the Veeva Quality system.
- Monitor deviation and CAPA trends to proactively identify systemic risks and improvement opportunities.
Veeva Quality System Ownership
- Serve as one of two Global Regulatory Affairs business process owner for relevant Veeva Quality modules (e.g. Deviations, CAPA, Audit Management).
- Work with the senior director, Compliance, Procedures and Learning to suggest and IT to support system enhancements, new process rollouts, and continuous improvements.
- Ensure accurate reporting, dashboards, and KPIs to support management oversight and inspection readiness.
Compliance & Continuous Improvement
- Ensure Global Regulatory Affairs processes align with global regulatory expectations (e.g. ICH, FDA, EMA, MHRA) and internal quality standards.
- Support the development and maintenance of Regulatory Affairs SOPs, WIs, and training materials related to compliance and quality systems.
- Lead or contribute to cross‑functional initiatives to strengthen regulatory compliance culture and inspection readiness.
Provide guidance and coaching to RA staff on audit conduct, deviation management, and CAPA best practices
Your Qualifications And Experience
- Bachelor’s Degree in Life Sciences.
- Required 8+ years relevant experience in Regulatory Affairs, including Compliance.
Also Good to Have
- Experience in Pharmaceutical Quality.
- Confident stakeholder engagement at senior levels
- Ability to manage multiple priorities and meet critical timelines
- Must have good self awareness to be able to speak up and ask for help when needed
- Must have positive organisational and follow-up skills
- Must have good interpersonal and communication skills
- Demonstrated skill in personal initiative
- Able to work collaboratively in a fast‑paced, time‑critical environment, meeting tight deadline
How We’ll Take Care Of You At Teva India, care is at the heart of how we work. From your first day, you’ll be welcomed into a people-first culture built on inclusion, respect, and belonging. That support extends to you and your loved ones through benefits designed for real life. These include comprehensive medical insurance, OPD coverage, annual health checkups, term life and accident insurance, and confidential emotional wellbeing support through our Optum Employee Assistance Program. You’ll also enjoy healthy meals at work, holistic wellbeing initiatives, and volunteering programs that help you give back to the community.
Your growth matters too. You’ll have opportunities to build future-ready skills, collaborate on projects with global teams, explore internal career opportunities, and learn through programs such as our AI-enabled Teva Twist program, R&D; Academy, continuing education, and mentorship.
Join our vibrant workplace, where we celebrate milestones, festivals, achievements, and community impact together.
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.
📌 Sr Mgr Regulatory Affairs (Navi Mumbai)
🏢 Teva Pharmaceuticals
📍 Navi Mumbai