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 Affairs Strategy

Your tasks and responsibilities

 

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

 

  • Provide guidance and oversight to Global Regulatory Strategists (GRS) with regard to the development and implementation of global regulatory strategies to ensure alignment to Therapeutic Area (TA) portfolio and that key regions are captured in the global regulatory strategy;
  • Develop Regulatory Strategy for directly assigned projects by designing and assessing regulatory strategy options on a regional and global basis (as outlined in the Global Regulatory Plan);
  • Be actively involved in decision making on all key development questions in consideration of the therapeutic area portfolio via an assessment on the probability of regulatory success;
  • Supervise regulatory members of the global project team;
  • Represent Global Regulatory Affairs (GRA) on directly assigned global Project Teams;
  • Be responsible for training of the GRS and the oversight and review of submissions;
  • Ensure submissions are consistent with the TA portfolio strategy;
  • For directly assigned projects, develop submission materials for local and global submission, guide the review process, check for accuracy, scientific consistency, compliance to local and global HA regulations and completeness of submission;
  • Advise GRA management and/or other functional areas of regulatory trends and their relevance to the TA portfolio;
  • Keep abreast of changes in the global regulatory environment for the project and ensure that these are strategically translated to the TA portfolio;
  • Supervise and drive preparations for meetings and teleconferences with local and global HA officials;
  • Conduct regulatory due diligence on potential in-licensing opportunities.

     

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:

 

  • Advanced technical degree (Ph.D., M.D., D.V.M. or Pharm.D.) in life sciences with preferred at least 8 years industry experience with 3 - 5 years include global regulatory experience in related therapeutic area or 3 - 5 years of local regulatory experience in a highly drug-related country OR M.S. degree with at least 10 years industry experience OR B.S. degree with at least 10 years industry experience of which 5 years include global regulatory experience in related therapeutic area;
  • The incumbent must have expert knowledge of the region he/she will be responsible for (EMEA/ FDA regulations on Clinical trials applications and drug approval regulations);
  • Demonstrated interactions with global and local health authorities;
  • Expert knowledge of foreign regulations as well as of adverse drug event reporting requirements;
  • 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 team;
  • A thorough knowledge of company policies and procedures in drug development and maintenance as well as sensitivity to the diverse cultures comprising the global Regulatory community;
  • Incumbent must have demonstrated originality in problem solving as applied to drug Regulatory issues and have skills and experience dealing with drug Health Authorities.

 

Preferred Qualifications:

 

  • In-depth knowledge, domestic and foreign, of clinical trial methodology, clinical auditing procedures, and drug safety data collection.

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: NJ-Whippany
Functional Area:
Entry Level: