Sr. Executive - Regulatory Affairs - Mumbai
- Boehringer
- 2 to 3 Yrs
- Mumbai
- 4 years ago
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Job Description
*OUR COMPANY
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 POSITION
Support regulatory activities for NDA submissions , CTA submissions , Internal compliance and regulatory maintenance in India and international markets.
Tasks & responsibilities
- To collect and compile the documents, dispatch the various applications as per the requirements
- Tracking and archiving the acknowledgments/dossier in hard and soft copies on common drive
- CTA / NDA maintenance Updating the local pack insert, CMC updates, PSUR submissions, Registration certificate and Import license renewals
- Clinical trial maintenance (e.g. Protocol amendments,Annual status report,test license renewals etc.)
- Regulatory Databases - Update internal databases like CPD3 (Regulatory tracking) and CTA database (CTA time lines tracking)
- Update all the information and documents in database for initial application and subsequent variations
- Perform all the steps required for new launch request and subsequent changes
- LOS compliance
Requirements
- Education : Bachelor s degree, Master s degree B pharma and M Pharma
- 2-3 years regulatory experience of INDIA market
- Support in timely manner for NDA, CTA and Variations.
- Internal system compliance is crucial and shall be done in real time manner.
- Marketing ,Sales,Clinical Development,Medical Affairs,Finance,Logistics, Corporate DRA/PV, Regulatory agencies and distributors / agent in international markets.
- System friendly and systemic approach. Awareness of Indian regulations
- support in regulatory activities is essential to achieve registration timelines and internal / external compliance.
- Regulatory knowledge of domestic and international market
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: HR********H@Bo*****************m.com, Tel: + 91-22-7145-6700
,Employement Category:
Employement Type: Full timeIndustry: Medical / HealthcareRole Category: General / Other SoftwareFunctional Area: Not ApplicableRole/Responsibilies: Sr. Executive - Regulatory Affairs - MumbaiContact Details:
Company: BoehringerLocation(s): Mumbai
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Boehringer
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is researching, devel...
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