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Manager, Regulatory Affairs

Location: 

Allendale, NJ, US

Req ID:  1659
Job Type: 

Edgewell is a global team of over 6,000 visionaries, doers and makers. Our secret is people, and we are lucky to have an inspiring and collaborative global force of them. Our portfolio of over 25 brands touches lives in more than 50 countries by making useful things joyful. Together, we reimagine good mornings and endless summers, strive for more sustainable ways to beautify and bond, and do it all with not only confidence but determination.

 

 

Position Summary

With emphasis on over-the-counter drugs and cosmetic products for the region of North America (US/CAN), provides regulatory guidance and advises on regulatory requirements. Experience with EPA surface disinfectants a plus. Develops strategies for governmental approval to introduce new products to market. Manages submissions for pre-market approval. Authors internal regulatory guidelines, protocols, work instructions and standard operating procedures. Assists with the training of regulatory affairs personnel and provides direction on specific projects.  Assures all governmental reporting systems and documentation comply with applicable regulatory standards and requirements for OTC drug, cosmetic, consumer and other products. Hands-on responsibilities for the support of product registrations and company licensing needs, including supervisory responsibility for one or more colleagues.

 

Accountabilities

  • Manage and implement Regulatory Affairs strategies, policies and objectives in accordance with Company strategic plans.
  • Monitor and interpret changes in laws, standards and regulations; determine impact to business.
  • Provide regulatory guidance, risk assessment and management throughout the product lifecycle: New Product Development and Commercial project
  • Prepare submissions and reports for government agencies as required by product regulatory classification.
  • Develop impact assessments and drive implementation of compliance plans.
  • Review of product labels to ensure compliance with country-region specific labeling requirements.
  • Manager the pre-market registration or notification process to enable product sale.   
  • Maintains product registration/license portfolio for applicable countries/regions, up to date.
  • Participates/contributes to inspection visits by government officials or on internal audits
  • Develop personnel, set performance expectations and coach to help achieve goals. 
  • Represent EPC to trade association Committees or Task Forces as assigned.
  • Author or approve Regulatory and cross-functional guidelines, protocols, work instructions, SOPs.
  • Support and drive process improvements.
  • Participate as an effective member of cross-functional product teams.
  • Build library and network of regional regulatory resources.
  • Maintain specialized product category knowledge.

 

Required Education, Skills and Experience

  • B.A. / B.S. in regulatory affairs, chemistry, engineering, or life sciences
  • 10+ years of related experience with a B.A. / B.S. degree, within over-the-counter drugs, cosmetic and/or regulated consumer products;
  • Knowledge and experience on FDA and Health Canada regulatory and applicable laws and regulations, as well as of cGMP standards.
  • Some light lifting required, up to 25 pounds.
  • The position may also require occasional travel to other company locations and to external meetings.

 

Desired Skills and Experience

  • Strong knowledge and experience with OTC, cosmetic and/or consumer product regulatory frameworks, with emphasis in the region of North America (US/CAN).
  • Experience with EPA surface disinfectants a plus.
  • Prior supervisory experience, coaching/mentoring skills.
  • Strong technical and management skills.
  • Solid critical thinking and influencing skills.
  • Good negotiation skills, diplomacy and professional judgement are required.
  • Effective verbal / written communication, interpersonal, and relationship building skills. 
  • Ability to interface with internal and external contacts at all levels.  Ability to clearly communicate technical and non-technical information via verbal presentations and in writing. 
  • Ability to handle multiple tasks / projects simultaneously.
  • An independent thinker with ability to make sound decisions.
  • Solid computer skills.  Proficiency with Word, Excel, PowerPoint, e-mail and internet applications.

 

#LI-LC1

Edgewell is an equal opportunity employer. We do all we can to create a collaborative and diverse global team, where good ideas can thrive, and our colleagues can learn and lead. We prohibit discrimination based on age, color, disability material or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any legally protected status in accordance with applicable federal, state and local laws. We listen deeply and speak directly to create an environment that’s open to difference. We aim to bring joy to not only the products we create and the people we serve, but our colleagues across the globe too.

 


Nearest Major Market: New Jersey