Bayer Global Regulatory Manager I in Chesterfield, Missouri
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Global Regulatory Manager I
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Global Regulatory Manager I, are to:
Lead in a world-wide, cross-functional capacity in the development and implementation of global regulatory data and submission strategies to obtain or defend global authorizations, and enable product commercialization and global trade of associated agriculture commodities;
Lead and provide input on regulatory technical strategies for data development, technical reports and the development of high-quality submission dossiers in collaboration with other functions and global teams to support product authorizations in both crop production and commodity import countries;
Lead regulatory product teams in the development of project plans amidst complex and, at times, evolving data requirements and ensure the appropriate safety studies are budgeted, planned, implemented and completed on time to enable on-time global submissions;
Lead the development of global submission plans and authorization processes in coordination with regional and country teams;
Apply scientific/technical background to provide input on regulatory data development, technical reports and prepare or guide the development of high-quality submission dossiers in collaboration with other BSC functions and regional/countries teams to support product authorizations in both cultivation and import countries;
Drive effective, timely submission support strategies in collaboration with regional and country teams, developing appropriate responses to regulatory authorities’ technical questions and requests, challenging requests for additional data, ensuring outreach with authorities to promote timely completion of authorization processes and negotiating with authorities on optimal conditions of registration;
Represent Regulatory Science and provide leadership on multi-functional Research and Development (R&D) product development teams and product-specific commercial launch 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;
Develop and maintain expert understanding of the business and regulatory environment, including changes in relevant regulations and guidelines and adapt product strategy/plans to maximize probability of regulatory success to support business objectives and timelines;
Lead or collaborate with other BCS functions proactively addressing public and regulator concerns and manage a variety of issues related to BCS’ products;
Support stewardship and regulatory compliance throughout product life cycle;
Provide timely perspective to business/strategy team on regulatory trends, policies, decisions, options/response strategies, potential implications on business, market opportunities;
Lead BCS advocacy on industry implementation of new regulatory requirements, policy changes and regulatory environment improvements;
Lead regulatory 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 its intellectual property.
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:
Bachelor’s degree with at least 12 years of related experience or Master’s degree with at least 10 years of related experience or Ph.D. with at least eight years of related experience;
Experience in regulatory, biology, chemistry, plant biotechnology, agronomy or related field of study;
Strong analytical and strategic thinking skills with proven ability to effectively identify and manage critical issues and challenging projects and identify and drive strategic solutions to complex problems with significant impact to the business while working in ambiguous regulatory environments or situations;
Ability to utilize education and experience along with existing policies and procedures to lead within an organization and drive timely results;
Demonstrated ability to influence and collaborate broadly across diverse internal and external groups;
Be recognized for regulatory and/or related technical expertise and credibility.
Knowledge of regulatory requirements and several years of experience in regulatory area making submission and obtaining approvals for biotechnology trait products;
Experience managing regulatory policies/regulations that affect critical company assets;
Extensive knowledge and understanding of agronomic industry business and competitive landscape.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. 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.
Location: United States : Missouri : Chesterfield
Division: Crop Science
Reference Code: 419246