Boehringer Ingelheim
Website:
boehringer-ingelheim.com
Job details:
The Position
As our Regulatory Affairs Manager, you will play a critical role in ensuring patients continue to have access to innovative healthcare solutions. You will lead and execute local regulatory activities aligned with regional strategies and business priorities, maintaining product registrations, ensuring regulatory compliance, and helping the business navigate an evolving regulatory landscape.
In this role, you will work closely with cross-functional teams, health authorities, regulatory service providers, and key stakeholders across the organization. You will have the opportunity to influence product launches, support business growth, and help shape regulatory strategies that drive better patient outcomes.
Duties & Responsibilities
- Execute regulatory activities on time and in line with META strategies and local business priorities.
- Prepare, compile, and submit regulatory dossiers in accordance with local regulations and requirements.
- Maintain product registrations and marketing authorizations to ensure uninterrupted product availability.
- Support product shipments and ensure regulatory documentation remains current and compliant.
- Manage and maintain regulatory databases, records, acknowledgments, and filing systems.
- Monitor changes in the regulatory environment and provide insights on emerging requirements, industry trends, competitor activities, risks, and opportunities.
- Build strong relationships with health authorities, local agents, vendors, and regulatory service providers.
- Partner closely with colleagues across functions including Clinical Operations, Market Access, Medical, Pharmacovigilance, Marketing, Legal, Quality, Supply Chain, and Communications.
- Participate actively in brand team discussions and contribute regulatory expertise to support business objectives.
- Support budget planning and manage regulatory activity costs within approved limits.
- Contribute to risk management, crisis management, CAPA activities, and continuous process improvement initiatives.
- Drive operational excellence and bring innovative thinking to everyday regulatory activities.
- Share regulatory knowledge and mentor team members to strengthen overall team capability.
- Bringing new medicines and healthcare solutions to patients through successful regulatory submissions and approvals.
- Maintaining product licenses and registrations to safeguard business continuity.
- Identifying opportunities to accelerate patient access to innovative therapies.
- Supporting product launches and brand growth across your assigned therapeutic areas.
- Helping the organization anticipate and respond to regulatory challenges and market changes.
- Balance multiple regulatory priorities while consistently delivering high-quality results.
- Build trusted partnerships with internal and external stakeholders.
- Make informed decisions and confidently manage complex regulatory matters.
- Navigate changing regulations while identifying opportunities for business growth.
- Demonstrate accountability, ownership, and a solutions-focused mindset.
About our Future Employee
- Education: Bachelor’s degree in pharmacy or similar medical education
- Pharma experience with regulatory focus in a multi-national for at least 4-6 years.
- Experience of direct interactions with Regulatory Authorities.
- Prior people management experience is an asset.
- Skills and competencies should match at least the entry level of the Competency framework for the OPU Manager RA.
- Demonstrating RA knowledge, critical thinking and problem solving.
- Leading by example and demonstrating sound business acumen.
- Demonstrating cross functional collaboration & accountability
- Effective negotiation and communication and agility to changes.
- Solid understanding of D&C Act and Rules.
- Understanding of working practices at HA.
- Position is based at Mumbai
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Our Company
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.
Why Boehringer Ingelheim?
With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.
Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.
Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.
Want to learn more? Visit https://www.boehringer-ingelheim.com
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