Bayer Vice President, Regulatory Affairs Consumer Health North America in Whippany, New Jersey

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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.

Apply online

Vice President, Regulatory Affairs Consumer Health North America

Your tasks and responsibilities

The primary responsibilities of this role, Vice President Regulatory Affairs Consumer Health North America, are to:

  • Play a leading role on the North America (NA) Leadership Team – representing the Regulatory Affairs perspective on the regional operating strategy;

  • Lead the U.S. and Canada Regulatory Affairs Consumer Health (RA CH) teams and facilitate their development through individual development plans and performance assessment;

  • Drive development and implementation of new product regulatory strategies in the U.S. and Canada, considering the different legal status of the products, resulting in timely product approvals and/or launches;

  • Develop and ensure implementation of objectives for the regulatory teams;

  • Proactively identify regulatory and other business issues/risks and lead design/execution of mitigation plans within Regulatory and cross-functionally;

  • Oversee key team interactions with Food and Drug Administration (FDA), Health Canada and other government bodies;

  • Represent Bayer on key Trade Associations;

  • Monitor and shape evolving Regulatory legislation affecting the portfolio;

  • Ensure compliance through oversight of 1) development, review and training on applicable Stand Operating Procedures (SOPs), 2) internal and FDA audits, 3) all Health Authority product maintenance activities;

  • Oversee mergers and acquisition, as well as, product divestitures/discontinuations activities, resulting in high quality recommendations;

  • Provide North America Regulatory recommendations to all cross-functional leadership teams (on which the Vice President sits).

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:

  • Ph.D., M.D., or Pharm.D. degree with at least 10 years of Regulatory experience, OR M.S. Degree with at least 12 years of Regulatory experience, OR a Bachelor's degree with at least 16 years of Regulatory experience;

  • At least 6 years’ experience in a leadership position;

  • Regulatory track record in the Consumer Health industry of successful product registrations/launches preferably in Bayer CH Regulatory categories;

  • Strong expertise in the US/CAN regulatory submission/notification processes for medicinal products, devices and pesticides and in regulatory requirements for dietary supplements, cosmetics, and monographs. Demonstrated operational delivery is essential;

  • Demonstrated strength in articulating and solving complex regulatory issues;

  • Proven ability to communicate and negotiate effectively in English both verbally and in writing;

  • Proven history of team leadership through the ability to inspire, motivate and drive results;

  • Ability to identify and alleviate inefficiencies and hurdles through insightful, realizable solutions;

  • The successful candidate will display a strong sense of curiosity, proven business acumen and commercial orientation, drive for results and the ability to experiment.

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