Assistant Director US Regulatory Affairs Liaison

 

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Assistant Director US Regulatory Affairs Liaison 

 

Contributes to US regulatory strategy development and enactment, Food and Drug Administration (FDA) communications and negotiations to achieve timely product approvals with optimized labeling.

Prepares and manages submission documents and sets/develops processes to ensure 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. 

 

YOUR TASKS AND RESPONSIBILITIES

 

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

 

• Works closely with Lead US RA Liaisons (and other cross-functional stakeholders) for assigned products/projects;
• Can represent US Regulatory Affairs on Global Regulatory Teams and closely collaborates with Global Regulatory Strategist (GRS) to ensure US input in the Global Project Teams (GPT);
• Develops submission materials for US submissions, critically reviews submission documents and ensures quality, scientific consistency, submission completeness and compliance to FDA regulations and internal SOPs/processes;
• Identifies regulatory or related risks/issues and collaboratively develops mitigation and/or contingency plans;
• Develops US labeling (e.g. USPI) and packaging in close collaboration with other US RA Liaisons, GRS, Global Regulatory Affairs Labeling, US Ad Promo, and the US business in parallel to CCDS development;
• Organizes and drives preparations for FDA meetings ensuring the Bayer one voice policy and building a reputation of trust and credibility;
• Aids in negotiations with FDA ensuring the timely approval of US submissions with optimal labels;
• Aids in the alignment with US Market Access, Medical Affairs and Commercial to enable regulatory outcomes (e.g. labeling) that support market strategies;
• Aids in the management of external RA service partners;
• Participates in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs activities;
• Ensures pipeline products are compliant to FDA regulations and relevant Bayer SOPs/processes.

 

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:

 

Required Qualifications:

• M.D., J.D., Ph.D. or Pharm.D. or any degree in a relevant health science area;
• US FDA regulatory experience in related drug or device area;
• Ability to work collaboratively;
• Continually seeks feedback from peers to improve business outcomes and able to set and deliver against 90-day and long-term goals to achieve desired impact/outcome;
• Competencies:
  • Knowledge of FDA regulations, operating procedures and policies;
  • Knowledge of the drug/device development process;
  • Project management skills, including attention to detail, with the ability to focus on multiple issues at one time under time pressure;
  • Strong ability to communicate in both oral and written English, with persuasive and assertive negotiating skills.

Preferred Qualifications:

• 2 or more years of US FDA regulatory experience in related drug or device area.

 

 

 

 

 

 

    YOUR APPLICATION      

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. 
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. 

 

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