Director Regulatory Affairs Strategy- Womens Health Care

.pre {white-space: pre-wrap;} Your tasks and responsibilities

The primary responsibilities of this role, Director Regulatory Affairs, Strategy – Women’s Health Care 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;
  • Develops the local and global regulatory project goals from development through life cycle;
  • Supervise the development of multiple project goals on a local and global level;
  • 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;
  • 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 for directly assigned projects;
  • 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;
  • Be accountable for effectively leading a team that is responsible to set up the regulatory strategy for Women’s Health Care (WHC) in the U.S.;
  • Ensure external expert input by building and maintaining close relationships to ensure pressure testing of our regulatory strategies;
  • Work closely cross-functionally and provide expert input, to enable optimal timing for important steps of the regulatory plan;
  • Recruit, develop and retain key talent and ensure strategic succession planning for the department;

 

This position offers domestic relocation assistance

 

.pre {white-space: pre-wrap;} 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., DVM or Pharm.D. with eight (8) years  in medical research activities of which three to five (3-5) years include local/ global regulatory experience in related TA area, or M.S. degree with ten (10) years of medical research activities of which five to seven (5-7) years include local/global regulatory experience in related TA area, or B.S. degree with twelve plus (12)+ years of medical research activities of which ten to twelve (10-12) years include local/global regulatory experience in related TA area;
  • Expert knowledge of the regional and global regulations;
  • Demonstrated interactions with local and global health authorities;
  • Excellent communication skills, verbal and written;
  • A clear understanding of cultural and business needs in leading a diverse team;
  • Strong attitude to set a vision for an organization, develop according strategies and mobilize employees to achieve their objectives;
  • Strong analytical and strategic skills with good business acumen;
  • High ability to solve problems and to structure as well as to simplify complex tasks;
  • Ability to attract, develop and retain talent;
  • Good in dealing with ambiguity;
  • High customer focus;
  • Must embrace change and should possess the ability to effectively work in an international and multicultural environment;
  • Good emotional skills and personal insights;
  • Self-assured and is comfortable defending positions with high level management;
  • Excellent networking abilities.
  • Demonstrated Leadership skills

 

Preferred Qualifications:

 

  • Advanced technical degree Ph.D., D.V.M. or Pharm.D. in life sciences.

 

 

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.pre {white-space: pre-wrap;} 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.