Director Regulatory Affairs Strategy

  • Bayer
  • Full-Time
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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.



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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:


* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.