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.
Senior Regulatory Affairs Manager
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Senior Regulatory Affairs Manager, are to:
- Work with the Marketing Strategic Business for given area (Horticulture/Broadacre/ES/Biologicals/HT traits/Seed Growth) to support the unit in its short and long term planning and to help the registration team prepare to implement business goals;
- Convey critical knowledge of assigned products to alleviate or reduce regulatory impacts or costs;
- Work with relevant Bayer Crop Science (BCS) functions to ensure necessary studies to secure the registration of new registration projects and defense of our existing products / projects or third-parties' products in timely fashion;
- Support the budget process in close contact with Development experts;
- Manage plans, budgets and execute delivery of all regulatory studies in close contact with Development experts;
- Follow up the registration/evaluation process with Authorities, in case of critical issues or delays, guide the development of a solution;
- Discuss long term perspectives of market development and market access issues with Marketing function;
- Provide early warning to business on regulatory trends, decisions, their possible impact and how to respond;
- Engage with internal teams on digital and sustainability initiatives that impact current and future registrations;
- Steer the compilation of high-quality registration dossiers on time for major markets in close collaboration with other BCS functions.
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 eight years of relevant minimum experience or Master's degree with at least six years of relevant minimum experience or Ph.D. with at least four years of relevant minimum experience;
- In-depth knowledge of relevant regulations and requirements for submission of registration applications and other regulatory dossiers;
- A good understanding of all regulatory relevant scientific subjects;
- In-depth knowledge and understanding in agronomic industry business and competitive landscape;
- Ability to apply principles of precedents to new situations and anticipate how government personnel would analyze relevant factors;
- Displaying skills transferable to Regulatory Affairs (RA);
- Ability to represent RA at meetings with senior management and counterparts in Bayer CropScience and outside Bayer;
- Ability to participate and/or lead industry task forces initiatives;
- Ability to lead initiatives that are impactful to BCS;
- Ability to communicate to senior management the status of registration projects taking the necessary actions towards the business ‘needs;
- Ability to influence, set regulatory strategies for assigned assets and decide on the allocation of resources;
- Good understanding of the processes and scientific domains of Research and Development, as well as the general public, national and international regulatory bodies;
- Diplomacy paired with the ability to negotiate, patience and perseverance to deal with bureaucracies and cultural differences;
- Sound Problem Solving/ Conflict Management skills;
- Highly developed communication skills, negotiation skills and leadership skills.
Residence based may be considered for this role however the location preference is Chesterfield, MO.
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.
State: Residence Based
Location: Residence Based
Reference Code: 445235
Functional Area: Regulatory Affairs
Entry Level : Professional