Head Regulatory Affairs Job In Boehringer Ingelheim In Africa, India

Job DescriptionOUR COMPANYAt Boehringer Ingelheim we develop o 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 achieveTHE POSITIONTimely registration of products, renewals,external Coordination with various Government bodies for necessary approvals, testings reports and fulfill internal customer needs to be regulatory compliantTasks & responsibilities

• 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 and Regulatory bodies of Bangladesh, Srilanka and Nepal (BNS)
• Meet Launch Excellence timelines of products with active collaboration with Local/ Regional and Global teams
• PV complaints needs to follow SOP and timely closure and submission to local regulators
• Lead team and support business with on time product launch
• All internal trainings to be completed like CPD3 and Con viewer

Accountabilities:

• Identify the products and Registration in India/BNS OPU
• 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
• Aligning brand promotional campaigns and advocacy to Critical success factors
• Actively shape regulotory landscape working with Industry bodies/Govt/KOLs and Academia

Job Impact:The organic growth of the AH division depends on product registration, periodic launch of new products and early registration of products shall have impact on meeting business targets LTF of the division is linked to registrations.

Requirements:

• Master's in Veterinary Science/Master of Pharmacy or higher with specific regulatory experience in Veterinary product registration
• 15+ years experience in Regulatory in Animal Health/Human Pharma/medical Devices
• Experience and Leadership engagements with DCGI/CDSCO/ICAR/IVRI Hands-on experience in dealing the queries with regulators, technical knowledge in Veterinary vaccines and therapeutics
• Collaborator and team player and should have good managerial skills with demonstrated people management skills
• Veterinarian with sound technical knowledge in vaccines, therapeutics and Nutritional products
• Should know the local Regulations for product registration, Clinical Trials protocols, importation requirements, local testing requirements, Port clearance
• Leadership experience in previous Regulatory, Quality, Quality assurance, clinical development roles are desirable
• Should have experience in Launch Excellence, Dossier preparation and review with understanding of RC/ IL mandates for seamless business continuity
• Experience in product registrations pathway in Bangladesh, Sri Lanka and Nepal is added advantage

WHY BOEHRINGER INGELHEIMWith us, you can grow, collaborate, innovate and improve livesWe 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 growthWe 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 communitiesREADY TO APPLYClick the&ldquoApply On Company website"button Create an account or sign in and continue to register your profile, upload your resume, and applyin the company site.

For any technical issues or additional questions,contact HR Direct (Note:resumes should not be submitted to HR Directsince job applications are not processedvia email or phone call)HR Direct contact information:Phone: +91-22-7145-6700Email:

Boehringer Ingelheim is looking for .

Boehringer Ingelheim is looking for Any Graduate / Post Graduate profile candidates.