Manager, Regulatory Affairs

Edgewell is a global team of over 6,000 visionaries, doers and makers. Our secret is people, and we 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 cosmetic products and over-the-counter drugs for the region of North America (US/CAN), provides regulatory guidance and advice on regulatory requirements. Monitors regulations and State and Federal Levels. Assesses and communicates impact to different lines of business. Develops compliance strategies to introduce new products to market. Manages notifications and submissions to governmental bodies in the US and Canada. 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 internal reporting systems and documentation comply with applicable regulatory standards and requirements for OTC drug, cosmetic products. Hands-on responsibilities for the support of product listings, manufacturing facility registrations for the US and Canada markets. Supervisory responsibility for one or more colleagues.

 

Accountabilities

• Design 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 Innovation projects.
• 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.
• Manage pre-market product listings and manufacturing facility registrations where needed to enable product sale.
• Maintain product registration/license portfolio for US and Canada, up to date.
• Co-leads 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 regulatory resources.
• Maintain specialized product category knowledge.

 

Required Education, Skills and Experience

• B. A. / B.S . in chemistry, engineering, or life sciences
• 10+ years of related experience with a B.A. / B.S. degree, within over-the-counter drugs and cosmetic;
• 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 products regulatory frameworks, with emphasis in the region of North America (US/CAN).
• Prior supervisory experience, coaching/mentoring skills.
• Strong technical and management skills.
• Solid critical thinking and influencing skills.
• Good negotiation skills, diplomacy, tact 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.

 

The salary range for this position is $104,000- 156,000. Actual base salary offered to a candidate may vary based upon factors including, but not limited to, relevant experience, time in role, base salary of internal peers, prior performance, business sector, and geographic location. In addition to base salary, the competitive compensation package may include, depending on the role, participation in an incentive program linked to performance. 

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, marital 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.