Boehringer Ingelheim is a research-driven pharmaceutical company and one of the top 20 pharmaceutical firms worldwide. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally in over 100 countries and has more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine. In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 23.1% of its net sales.
Post : Manager, Regulatory Affairs
Job Description
• To Manage & execute the local RA activities according to ROPU RA strategies and local business priorities within the defined time lines.
• Maintain product registrations and RA databases; ensuring business continuity in compliance with internal and external regulations and requirements.
• Provide regular regulatory intelligence on changes in regulatory environment, competitor activity and opportunities to enable the business to realize risk or opportunities arising in the RA environment.
• Collaborate cross-functionally and make sure that all relevant stakeholders are timely and pro-actively updated on relevant RA topics.
• Have a strong interaction and partnership with the assigned authorities across in the OPU/cluster;
• Maintain efficient relationships with related Regulatory service Providers (local agents and vendors).
• Carry out agreed actions for the assigned local projects.
• Can deputize the OPU RA Head in external & internal stakeholders engagement as required.
• Support the OPU RA head in the continuous development of the team.
Tasks & responsibilities
REGULATORY STRATEGY AND REGISTRATION ACTIVITIES
1) Timely execution of RA activities as per the IMETA strategy and the OPU business priorities.
2) Compilation of the dossier as per local regulations and requirements.
3) Maintain MA and support product shipments.
4) Engagement with local graphic offices (if applicable) and maintenance of RA databases.
5)Tracking and archiving the acknowledgments/dossier in hard and soft copies on common drive
MANAGERIAL ACTIVITIES
1) Involved in Budget preparation.
2) Deputize OPU Head of RA in escalation discussion for product and non-product local topics to ROPU.
3) Encourage innovation in our daily activities
4) Can carry out OPU Head of RA responsibility partially or fully in an interim situation as needed.
MANAGERIAL ACTIVITIES
1) Involved in Budget preparation.
2) Deputize OPU Head of RA in escalation discussion for product and non-product local topics to ROPU.
3) Encourage innovation in our daily activities
4) Can carry out OPU Head of RA responsibility partially or fully in an interim situation as needed.
REGULATORY INTELLIGENCE
1) Communicate and discuss new/updated information within regulatory environment, competitive regulatory intelligence and/or new requirements in the country with the OPU and IMETA stakeholders.
2) Support to compile the required regulatory expertise to support future BI portfolio.
EXTERNAL / Internal RELATIONSHIPS AND ENGAGEMENT
External Stakeholders
1) Health Authority Interactions.
2) Maintain successful Regulatory service Provider (RSP) relationship.
Internal Stakeholders
LEAD/ENGAGE IN CROSS FUNCTIONAL COLLABORATION
3) Implement the OPU cross-functional interaction plan.
4) Be a valued partner to other functions in Human Business Pharma (e.g. ClinOps, Market Access, Marketing, Medicine, PV, Legal, Supply Chain, Communication, QM, etc.), empowering them to understand the regulatory requirements and implications for their business area.
5) Participate actively in the Brand teams & other related brand meetings
QUALITY AND COMPLIANCE
1) Adherence to BI SOPs, ROPU processes and local regulations.
2) Contribute to CAPA process as appropriate.
3) Perform day-to-day tasks with expected Quality.
4) Contribute in risk/crisis management.
SUPPORT FOR LOCAL AND GLOBAL PROJECTS
1) Provide timely input to line manager on topics supporting ROPU and Global projects.
2) Provide regulatory Intelligence to line manager to support local project team (where applicable).
TRAINING AND DEVELOPMENT
1) Active sharing of regulatory expertise/experience with local regulatory team.
2) Prioritize personal development as per competency framework and business need
3) Practice innovation mindset and operational excellence.
Candidate Profile
Bachelor Degree in Pharmacy or similar medical education
Pharma experience with regulatory focus in a multi-national for at least 6-8 years.
Experience of direct interactions with Regulatory Authorities.
Prior people management experience is an asset.
Additional Information
Experience : 6-8 years
Qualification : Bachelor Degree in Pharmacy
Location : Mumbai
Functional Area : Regulatory Affairs
End Date : 15th December, 2022
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