19 February, 2022
About the job
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.
Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.
The Incumbent is responsible for timely registration of products, renewals,external Coordination with various Government bodies for necessary approvals, testings reports and fulfill internal customer needs to be regulatory compliant.
Tasks & Responsibilities
- Identify the products and Registration in India OPU ( India, Bangladesh, Sri Lanka and Nepal)
- Coordination with Global, Internal and external teams for timely renewal of market authorizations
- Pharmacovigilance compliance and coordination with teams for timely submission to regulators
- Coordination with Global RA and Local colleagues for Dossier compilation, review,and submission
- Ensure development of Artworks as per regulations
- Coordinate with regulators, Institutions,Testing Labs, Port officials for product clearances
- Review of Marketing materials and other publishing information of regulatory compliance
- Education : Bachelor’s degree, Master’s degree on Veterinary Science/Master of Pharmacy or higher with specific regulatory experience in Veterinary product registration
- Minimum of 4 years regulatory experience of INDIA market
- Ensuring all product registrations, renewals, artworks, PV complaints meets local regulations
- The job needs to fulfill regulations as laid down by CDSCO, Government of India
- PV complaints needs to follow SOP and timely closure and submission to local regulators
- All internal trainings to be completed like CPD3 and Con viewer
- Aware of local regulations
- Should know how to file SUGAM application, query response & follow ups at DCGI office.
- Position will be based at Mumbai
WHY BOEHRINGER INGELHEIM?
With us, you can grow, collaborate, innovate and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym, best-in-class cafeterias and coffee bars to keep you energized and healthy and other various benefits and rewards. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.
READY TO CONTACT US?
If you have questions about the application process, please contact HR Direct: HRDirect.PH@Boehringer-ingelheim.com , Tel: + 91-22-7145-6700
Job: Medicine / Regulatory Affairs
Primary Location: Africa, Asia, Australasia-IN-Maharashtra-Mumbai
Organization: IN-Boehringer Ingelheim India Pvt Ltd (India)