Regulatory Affair Manager

Bayer•Chesterfield, MO

17h

About The Position

You will achieve and defend registrations by managing and steering regional and/or country registration activities for new or existing projects. Additionally, you will develop and implement local / regional regulatory strategies from Research until phase out / divestment to optimize the value of specific projects. Finally, you will cooperate with Regulatory Authorities, through country, regional and Global networks, thereby shaping the reputation of BCS as a leader in the regulatory arena and ultimately achieving registrations for new projects and safeguarding those for existing ones according to business objectives. The primary responsibilities of this role, Regulatory Affair Manager, are to: In association with regions, develops an understanding of the regulatory strategies to obtain registrations and defend products; With some oversight and guidance, and in coordination with RRMs, summarizes data across study types and prepares core dossiers and technical positions for regulatory submissions as required; Maintain registrations through timely compliance with all regulatory requirements; Develop thorough understanding of regulatory history and associated issues with assigned projects; With some oversight, work with relevant 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 a timely fashion.

Requirements

Bachelor's degree
Good level of knowledge of relevant regulations and requirements for submission of registration applications and other regulatory dossiers
A basic understanding of all regulatory relevant scientific subjects
Good level of knowledge and understanding in agronomic industry business and competitive landscape. Displaying skills transferable to Regulatory Affairs
Ability to represents Regulatory Affairs in meetings (internally and externally) with senior management and peers. Leads or participates in multifunctional teams
Ability to represent Bayer on certain industry task forces. Reports results, information to authorities independently
Ability to contributes to organizational regulatory compliance as required
Developed written and oral communication skills
Excellent listening skills and the ability to get the message across clearly
Ability to convey thoughts clearly and concisely
Ability to put complex regulatory science into simple / clear market business relevant term
Strong leadership skills, negotiation skills, problem solving, and conflict management skills
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 are essential

Nice To Haves

Bachelor's degree with 6 years of minimum relevant experience; OR
Master's degree with 4 years of relevant minimum experience; OR
Ph.D. with 2 years of relevant minimum experience.

Responsibilities

Develops an understanding of the regulatory strategies to obtain registrations and defend products
Summarizes data across study types and prepares core dossiers and technical positions for regulatory submissions as required
Maintain registrations through timely compliance with all regulatory requirements
Develop thorough understanding of regulatory history and associated issues with assigned projects
Work with relevant 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 a timely fashion.