Senior Regulatory Affairs Manager

 

Sr RA Mgr 

         

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of this role, Regulatory Affairs Manager, are to: 

 

• Achieve and defend crop protection pesticide registrations by managing and steering registration activities for new or existing projects;
• Develop and implement regulatory strategies from research/development through phase out / divestment, and continued compliance maintenance post phase/out divestment;
• Optimizes the value of specific projects;
• Key interface between Portfolio Management and Development Functions to provide overarching strategic direction and leadership necessary to align the long-term needs of the  business and the Development functions to succeed in a process-oriented organization;
• Co-operate with Regulatory Authorities, through country, regional and national networks, thereby shaping the reputation of BCS as a leader in the regulatory arena and achieving registrations for new projects and safeguarding those for existing ones according to business objectives;
• Compile and submit regulatory packages and dossiers necessary for registration across all States without guidance and oversight;
• Leverage knowledge of regulations by making special registration recommendations to expand business opportunities, and submit packages to regulatory agencies as directed;
• Regularly coordinate with asset team on business needs and provides transparency on upcoming and pending actions;
• Act without guidance, drive more complex regulatory submissions such as new active ingredient submissions to state agencies, and directs extended asset teams on regulatory needs;
• Manages state-initiated regulatory processes and reviews such as Re-Registrations, Human Health Risk Assessment, and etc.;
• Maintain regulatory database tracking systems for products;
• Process payment of state registration fees ( i.e., new product registration fees and annual state renewal fees and submit state renewals / licenses for BCS products;
• Maintain knowledge of current pesticide regulations and contact with key regulatory authorities;
• Train new hires and junior team members on internal processes, regulatory strategies, and compliance-related items; 
• Ensure compliance with all applicable requirements, including but not limited to ensuring that product-labeling claims are correct and current;
• Assist with certain federal registration strategies and submissions and lead cross-functional internal drive teams and project groups;
• Present complex state regulatory information, processes, critical knowledge, and strategies to senior management;
• Represent Bayer by participating in industry meetings and leading industry task forces, including providing input on proposed regulations, and drafting proposed position papers and proposals representing Bayer Crop Science’s' interests.

 

WHO YOU ARE

 

Bayer seeks an incumbent who possesses the following:

 

 Required Qualifications:

 

• H.S. Diploma or GED;
• Expert knowledge of regulatory requirements; 
• In-depth knowledge and understanding in agronomic industry business and competitive landscape;
• Extensive experience independently making pesticide regulatory submissions to government agencies and managing escalated regulatory issues;
• Displaying skills transferable to RA;
• Ability to represent RA in meetings with senior management and counterparts in Bayer CropScience and outside Bayer. 
• Ability to participate and/or lead Industry Task Force Initiatives that are impactful to BCS;
• Ability to ensure senior management is aware of the status of registration projects taking the necessary actions towards the business ‘needs;
• Ability to influence authorities, set regulatory strategies for assigned assets, and decide on the allocation of resources;
• Expert level 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.

 

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