Share this Job

Manager-Regulatory Affairs, Schick (Remote Based-US)

Location: 

Remote, NJ, US

Req ID:  1671
Job Type: 

We are a global team of 6000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we reimagine good mornings and endless summers, beauty and bonding, confidence and determination.

 

 

 

Position Summary:

 

 

This position provides regulatory guidance and advised on regulatory requirements with emphasis on over-the-counter drugs, cosmetic products, and consumer products for the region of North America (US/ CAN). You will work on developing strategies to gain governmental approval to introduce new products to the market and manage those submissions for pre-market approval. In addition, you will have 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 projects
  • Prepare submissions and reports for government agencies as required by product regulatory classification.
  • Ensures all governmental reporting systems and documentation comply with applicable regulatory standards and requirements for OTC drug, cosmetic, consumer and other products.
  • Develop impact assessments and drive implementation of compliance plans.
  • Support new and currently marketed products including label review ensuring compliance with country-region specific labeling requirements and managing changes requiring government approval.
  • Manage the pre-market registration or notification process to enable product sale.
  • Maintains product registration/license portfolio for applicable countries/regions, up to date.
  • Participate/contribute to inspection visits by government officials or on internal audits
  • Develop personnel, set performance expectations and coach to help achieve goals.  Assists with the training of regulatory affairs personnel and provides direction on specific projects.  Prioritize and guide the work of colleagues(s) to ensure commitments are met.
  • 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 OR 3 years of direct, related experience
  • 10+ years of related experience within over-the-counter drugs, cosmetic and/or regulated consumer products OR 13+ years of related experience within over-the-counter drugs, cosmetic and/or regulated consumer products in lieu of bachelor's degree
  • 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

  • Experience with electrical/battery operated consumer goods and sustainable plastic/packaging a plus.
  • Knowledge of US/CAN OTC/Cosmetic landscape including State Regulation with a knowledge of EU/International a plus.  Knowledge of increased Consumer Product Safety Regulation/CPSC process a plus.
  • 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.

 

 

 

Edgewell is an equal opportunity employer, and we prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any other legally protected status in accordance with applicable federal, state and local laws.