Director US Regulatory Affairs Liaison

The Director US Regulatory Affairs Liaison develops US regulatory strategies for key projects, achieving fast, resource efficient submissions of high-quality dossiers, driving Food and Drug Administration (FDA) communications and negotiations to achieve timely product approvals with optimized labeling.

Ensures Bayer PH US Regulatory Affairs (RA) product registration activities are in line with the short- and long-term US commercial and global R&D objectives and in compliance with all regulatory and legal obligations. This position will have to consider the business objectives and priorities of the Country Divisional Heads as well as those of the Global Regulatory Head and R&D organization.

Inspires and trains US regulatory staff, through visionary, architect, catalyst, and coach (VACC) principles, developing functional capabilities, creating an environment of inclusion and diversity, building a talent bench and driving a transparent, and vibrant learning culture built on company values.

This role requires a Regulatory Expert who can lead complex projects for high priority programs in order to achieve US registrations.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Director US Regulatory Affairs Liaison, are to:

• Demonstrates, credibly embodies and role models VACC leadership being a (n):

• Visionary that guides teams in defining the outcomes to deliver on the mission.
• Catalyst that removes roadblocks to facilitate connections and collaboration.
• Architect that shapes a value creating system to unleash the passion and energy of our people.
• Coach that helps teams learn and build the capabilities needed to create value for the customer and stakeholders.

• Develops and enacts US regulatory strategy (clinical/labeling) and outcomes on key and/or multiple products, indications or projects, working closely with cross-functional colleagues and the FDA;
• Acts as a critical collaborative partner with the Global Regulatory Affairs organization to ensure FDA/US input into product development;
• Represents US Regulatory Affairs on key Global Regulatory Teams and closely collaborates with GRS to ensure US input in the Global Project Teams (GPT).
• Oversees and develops submission materials for US submissions, guides the review process, critically reviews submission documents and ensures quality, scientific consistency, submission completeness and compliance to FDA regulations and internal SOPs/processes;
• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans;
• Responsible for developing US labeling (e.g. USPI) and packaging in close collaboration with the GRS, Global Regulatory Affairs Labeling, US Ad Promo, and the US business in parallel to CCDS development;
• Responsible for FDA meeting preparation and leads FDA communication safeguarding the Bayer one voice policy and building a reputation of trust and credibility;
• Leads negotiations with FDA ensuring the timely approval of US submissions with optimal labels;
• Leads alignment with US Market Access, Medical Affairs and Commercial to enable regulatory outcomes (e.g. labeling) that support key market strategies;
• Leads strategic input into US due diligence of in- and outlicensing pipeline products;
• Plays a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs activities;
• Ensures key pipeline products are compliant to FDA regulations and relevant Bayer SOPs/processes.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• US FDA regulatory experience in related drug or device area;
• Demonstrated team leadership with the ability to lead without authority, foster a positive work culture, coach and drive vision and purpose;
• In-depth knowledge of the US regulatory affairs environment with a proven track record in product approvals and FDA relationship management;
• In-depth knowledge of FDA regulations, operating procedures and policies;
• Very strong knowledge of the drug/device development process;
• Exceptional project management skills, including attention to detail, with the ability to focus on multiple issues at one time under time pressure;
• Proficiency in managing significant ambiguity and effectively and proactively steering and solving diverse and complex business and regulatory issues;
• Strong ability to communicate in both oral and written English, with proven persuasive and assertive negotiating skills.

Preferred Qualifications:

• M.D., J.D., Ph.D. or Pharm.D. or equivalent is preferred with education in a relevant health science area;
• 6 or more years of industry experience;
• Oncology experience is preferred.

Employees can expect to be paid a salary of between $169,865 to $254,798.  Additional compensation may include a bonus or commission (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors. 

This posting will be available for application until at least: 6/20/2025.

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