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.

Director Regulatory Policy & Intelligence, Pediatric Medicine

Your tasks and responsibilities

The primary responsibilities of this role, Director Regulatory Policy & Intelligence, Pediatric Medicine, are to: 

 

  • Establish his/herself as the Pediatric Regulatory Lead for Bayer Research & Development (R&D) and drive the generation and implementation of a global Pediatric Regulatory Strategy at Bayer, and, where needed, the generation and implementation of business processes, Standard Operating Procedures (SOPs), and cross-functional trainings on pediatric-centric regulatory matters; 
  • Define and lead a pediatric regulatory science innovation function, and co-lead the cross functional Bayer’s internal Pediatric Advisory Group (PedAG);
  • Actively contribute to pediatric regulatory policy making outside of Bayer and serve as key contact for respective external initiatives. Coordinate Bayer representation in external working groups and initiatives dealing with pediatric regulatory policy and innovation topics (EFPIA, PhRMA, BIO, IMI);
  • Monitor external global trends (new policies, legislations, and guidelines) concerning pediatric development, analyze impact, opportunities and risks for Bayer, present those to management and support respective adaptation of our internal approach;
  • Act as a consultant for Global Program Teams (GPTs) regarding questions and issues around pediatric development, in particular to foster pediatric regulatory strategies that are globally compatible and innovative;
  • Actively promote knowledge and information-sharing about pediatric-centric regulatory matters internally via communications, presentations, and trainings;
  • Provide assessment of in- and out-licensing projects with regard to pediatric-centric regulatory matters, including various regional, related incentives for due diligence projects.

     

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:

 

  • B.S. or B.A. degree in one of the basic sciences or a business discipline, plus at least six years’ of relevant experience, OR advanced healthcare professional degree(e.g., M.D., Pharm.D.) or technical degree Ph.D., DVM  with at least 3 years’ of relevant experience;
  • Professional and academic experience with at least 5 years of pharmaceutical industry or health authority experience, with 3 years of experience in drug development;
  • Expert knowledge of the regional and global regulations concerning pediatric development;
  • Experience in some of the key project or development related functions (Product Development, Project Management, Regulatory Affairs, Quality Assurance);
  • Excellent communication skills, verbal and written, and strong analytical skills;
  • Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills;
  • A clear understanding of cultural and business needs in leading a diverse, multi-national team.

Your application

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. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. 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.

 

Country: United States
Location: DC-Washington, NJ-Whippany