Mgr Regulatory Affairs

Teva Pharmaceuticals; Karnataka; Sur place; INR 3 000 000 - 6 000 000; Plein temps

Avantages offerts par ce poste

Medical insurance

OPD coverage

Annual health checks

Life & accident insurance

Employee assistance program

Healthy meals at work

Wellbeing programs

Volunteer opportunities

Résumé du poste

Teva India is seeking a Regulatory Affairs professional with 10+ years of experience to manage submissions and lifecycle activities for Branded, Specialty and Generic products in International Markets (IM). You will ensure compliance, coordinate variations, renewals, labeling, and provide regulatory guidance to support supply continuity.

The role emphasizes regulatory intelligence, collaboration with market teams, and maintaining regulatory records in systems such as GRIDS, GI Insights, Teva Art

Qualifications

• B. Pharm / M. Pharm with 10+ years regulatory experience.
• Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (International Markets Preferred).
• Good knowledge of pharmaceutical & scientific processes and lifecycle management.

Responsabilités

• Manage submissions and maintenance activities for IM region in collaboration with market regulatory teams.
• Ensure full compliance of marketed products and manage post-approval changes (variations, site transfers).
• Provide regulatory intelligence and guidance to ensure supply of medicines in IM region.
• Capture RA activities in regulatory tracking system.

Connaissances

Regulatory submissions

Lifecycle management

CMC variations

Labeling

Formation

B. Pharm / M. Pharm

Outils

GRIDS

GI Insights

Veeva

Teva Art

Description du poste

We Are TevaWe’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.Our Team, Your ImpactManagement of the submission and approval process for Teva products International Markets (IM) to support business opportunities for the company.Management of regulatory compliance including product life cycle maintenance (Variations, renewal, etc), data sheets, labelling, regulatory compliance files and regulatory databases.Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction.How You’ll Spend Your DayRegulatory SubmissionsManage all submissions and maintenance activities related to Branded/Specialty and Generic products in IM region in close collaboration with assigned market regulatory team. This includes variations, renewals, response to HA queries, labeling activities etc.Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity.Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc)Drive data and digital initiatives as per organizational goals and look for opportunities to increase efficiency of regulatory workload/process via automation opportunitiesRegulatory Intelligence/Expertise/Guidance/EducationProvide regulatory guidance to ensure that Teva can meet the responsibilities of an importer, distributor and sponsor, to ensure supply of safe and effective medicines, including supply of unapproved medicines, as required by Health AuthoritiesProvide regulatory intelligence and maintain thorough and up-to-date understanding of the regulatory environment in IM region byproviding impact analysis feedback to commercial teams.Capture monthly activities via reports and capture RA activities on an ongoing basis in the regulatory tracking system.Ensure regulatory records and files are maintained electronically for ready record retrieval and life cycle management, in accordance with global and local requirements.Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and planned products, share this information with appropriate personnel and assist in the development of strategies and plans of action to address them.Work closely with market RA in International Market RA Regions to complete all assigned activitiesYour Skills and ExperienceB. Pharm / M. Pharm (preferred) with 10+ years of experience, regulatory experience in CMC variations, labeling and life cycle management.Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products and medical devices.Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (International Markets Preferred).How We’ll Take Care of YouAt 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.Already Working @Teva?Make sure to apply through our internal career site on Twist—your one-stop shop for career developmentTeva’s Equal Employment Opportunity CommitmentTeva 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.