At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.
Global Regulatory Manager II (Crop Science)
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Global Regulatory Manager II (Crop Science), are to:
- Leads in a worldwide, cross functional capacity in the development and implementation of global regulatory data and submission strategies to obtain or defend global authorizations, ensure optimal regulatory terms for new or existing products, and enable product commercialization/License To Operate (LTO) and global trade;
- Leads cross functional product core teams in Regulatory Science and works closely with colleagues in Research & Development as new products are handed off to Regulatory Science to develop and implement a robust assessment strategy that fully characterizes and evaluates product safety, meets global regulatory requirements in cultivation and import countries and seeks to alleviate or reduce unnecessary regulatory requirements, impacts or costs;
- Leads product core teams and collaborates with safety centers on development of project plans and ensures the appropriate studies are budgeted, planned, implemented and completed on time to enable on time global submissions;
- Leads the development of global submission plans and steers the global submission and authorization processes in coordination with regional and country teams for assigned products;
- Applies significant scientific/technical background to provide input on regulatory data development, technical reports, and prepares or guides the development of high-quality submission dossiers in collaboration with other Bayer Crop Science (BCS) functions and regional/countries teams to support product authorizations in both production and import countries;
- Drives effective, timely submission support strategies, using state of the art knowledge and assessment, in collaboration with regional and country teams, leading development of appropriate responses to regulatory authorities technical questions, challenging requests for additional, unnecessary data where justified, ensuring outreach with authorities to drive for timely completion of authorization processes, and negotiating with authorities on optimal conditions of registration;
- Represents Regulatory Science and provides leadership on multi-functional R&D product development teams and product specific commercial launchs teams to communicate regulatory plans and timelines, advise on regulatory options and business implications, and enable effective strategic and cross functional development planning for new product launches and growth opportunities;
- Develops and maintains an in depth understanding of the business and regulatory environment, including changes in relevant legislation and guidelines, and adapts product strategy/plans to maximize probability of regulatory success to support business objectives and timelines;
- Leads or collaborates with other BCS functions proactively addressing public and regulator concerns and managing a variety of issues related to company reputation;
- Supports regulatory compliance throughout product life cycle (from launch until discontinuation). Partners with regional stewardship teams on compliance activities to ensure that products are in conformance with local government guidelines and regulations;
- Partners with the regional commercial groups and management to ensure that products are managed to have optimal market penetration. Supports product discontinuation activities;
- Manages relationships with other seed companies to fulfill all regulatory provisions within trait license agreements and other collaborative agreements to enable Bayer's business plans and protect intellectual property;
- Participates in BCS advocacy on industry implementation of new regulatory requirements, policy changes and regulatory environment improvements;
- Provides scientific collaboration to align on regulatory strategies and leads efforts for development of regulatory data package and agency submissions to support product approvals;
- Helps develop and share timely perspective to business strategy team on regulatory trends, policies, decisions, options/response strategies, potential implications on business, market opportunities that impact product development and launch plans;
- Ensures that coherent, consistent, and effective regulatory strategies are applied across Bayer's Biotechnology trait portfolio to resolve issues and obtain and maintain product authorizations globally.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Ph.D. with 6 or more years of relevant experience OR Master's degree with 8 or more years of relevant experience OR Bachelor's degree with 10 or more years of relevant experience;
- Knowledge of relevant regulations and requirements for submission of biotechnology trait applications and other regulatory dossiers;
- Shows ability to apply principles of precedents to new situations and anticipate how government personnel would analyze relevant factors;
- Ability to independently set regulatory strategies and influence internal and external regulatory stakeholders;
- Highly results oriented with proven leadership and project management skills to successfully drive projects and initiatives to completion, delivering on critical timelines, and effectively driving change across the function.
Domestic relocation may be available for this role.
Sponsorship may be available for this role.
Position will be based in Chesterfield, MO (St. Louis area).
Position may include opportunity to work in hybrid model including remote work up to 40%.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
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|IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer expects its employees to be fully vaccinated against COVID-19. Bayer active employees are also expected to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status to Occupational Medicine. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, Bayer employees are also required to comply with state, local and customer requirements. || |
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|Location: ||St. Louis|Chesterfield || |
|Division: ||Crop Science || |
|Reference Code: ||704481 || || |
|Contact Us |
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|Email: ||firstname.lastname@example.org |