Bayer Associate Director Regulatory Strategy Suncare in Whippany, NJ, New Jersey
Your tasks and responsibilities
The Associate Director Regulatory Strategy Suncare, within Regulatory Affairs Strategy Personal Care (RAS PC) is responsible for the development, alignment, and implementation of regulatory strategies to ensure the earliest submissions and approvals Suncare products and regulatory outcomes aligned with broader BCH business strategy. Additionally, he/she may be assigned to act as a liaison to trade associations to represent Bayer Consumer Health position on regulatory matters related to Suncare products.
The incumbent will: •Provide regulatory recommendations on global labeling strategy for new products; •Formulate global regulatory strategies and timelines for new product development (NPD) for dermatology and Suncare and provide support to local affiliates with strategy formulation and registration requirements for said products; •Monitor global industry regulations and guidelines and adjusting regulatory strategies accordingly ; identifying and developing plans to mitigate regulatory risks as the environment requires; •Effectively communicate regulatory strategies for new Suncare products to Regulatory colleagues and internal Bayer Consumer Health stakeholders; •Representing Regulatory Affairs on assigned project teams; •Coordinate selection and oversight of regulatory strategy consultants and outside vendors; •Serve as subject matter expert and mentor for other Regulatory Affairs (RA) team members; •Deputize for the Category Lead Personal Care, RAS, in certain committees and/or in- and external meetings; •Participate in due diligence activities for Suncare products.
Who you are
Qualifications: Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, Efficiency) values. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:
•Bachelor’s Degree (or international equivalent) with a minimum of ten years of proven experience, a Master’s Degree (or international equivalent) with a minimum of six years of proven experience, or a Ph.D. (or international equivalent) with a minimum of four years of proven experience; •Proven international regulatory experience in consumer health care; •Expertise in US and European regulations for drugs, medical devices, and cosmetics; •Demonstrated ability to articulate and solve complex regulatory issues; •Strong decision-making skills; •Entrepreneurial mindset; •Strategic orientation; •Proficiency in Microsoft Office: Word, Excel and PowerPoint; •Ability to gain expertise in additional regional regulations for drugs, medical devices and cosmetics as required ( Latin American and Asia Pacific); •Ability to communicate effectively in English both verbally and in writing; •Ability to work well within a team.
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 Minorities / Females / Protected Veterans / Disabled