Dir, Regulatory, Sun/Skin/Fem

Edgewell is not just a company, but a vibrant global community of  6,800 visionaries, doers, and makers . Our family of over  25 personal care brands serves people in more than  50 countries . We are dedicated to infusing joyfulness into every aspect of our work. Our pledge goes beyond our products, with our fundamental value of  People First  guiding us to foster a diverse, inclusive, and respectful environment where every team member can flourish and celebrate our shared achievements.

Position Summary :

A senior leader within the Global R&D organization who oversees all activities related to regulatory compliance across all Edgewell’s brand portfolio.  Responsible for assessing, interpreting, and following global regulations for OTC drugs, medical devices, cosmetics, biocides and consumer goods. Ensures standards are implemented and maintained across the organization, as well as ongoing and future regulatory compliance planning and proof of cGMP. Lead the design of regulatory strategy pathways aligned with company objectives as well as the provision of regulatory guidance at all levels of the organization.  Establish and maintain impactful working relationships with internal and external business partners as well as other stakeholders such as industry associations, lobbying groups, public health groups, public relations and communications.  Promote an environment of continuous improvement within areas of responsibility while exemplifying Edgewell’s values and behaviors.

Accountabilities

• Responsible for leading Edgewell’s Global Regulatory organization.
• Demonstrate strong business acumen, organizational awareness and influencing skills.
• Defines regulatory strategy with high level of accuracy and proven success by effectively assessing new markets, or new regulatory classifications.
• Leads provision of Regulatory guidance, as well as the planning of on-going compliance activities across product categories.
• Manages communications and relationship building efforts with Company’s affiliates, business partners, industry associations and government authorities.
• Comprehensive risk-based regulatory assessments, strategy design, guidance that allow the business to achieve goals on time and within budget. Identifies and recommends alternative, more efficient regulatory pathways at early stages.
• Represents EPC and holds official positions in trade association leadership globally.
• Develops relationships with government authorities (Canada, Latam, AUS, EU) at appropriate touch points to help explain company positions, product related decisions and provide feedback on impact to industry.
• Leads cross functional initiatives to advance business goals by identifying areas for alignment, collaboration,and partnership with other departments (e.g., Quality Assurance, R&D, Marketing, Legal and others).
• Key contributor on core teams developing responses to government agencies, retailers, consumer associations.
• Effective and direct involvement in advocacy and government relations with significant influencing of regional regulations and regulatory agendas of Health & Trade authorities in key country-markets with positive impact to business.
• Recognized as a subject matter expert by trade associations and external peers globally, that identifies industry issues, impact assessments and influences industry wide positions before regulatory bodies, health authorities.
• Identifies the need for and vetting of consultants to advise EPC and supplement internal expertise.
• Successfully leads inspection readiness activities.
• Contributes to cross-functional assessments on product compliance using a risk-based approach.
• Identifies product related issues, or ingredients with emerging regulatory, retailer and consumer sentiment concerns for EPC business partners, influences / drives related decision making.
• Oversees effective regulatory programs that meet compliance / licensing requirements for OTC drugs, cosmetics and consumer goods.
• Drive continuous process improvements to mitigate risk, streamline processes and improve efficiencies.
• Represent EPC before government authorities such as FDA, Health Canada, TGA  and others.
• Maintains understanding of applicable regulations (FDA, Health Canada, TGA, and ICH guidance, EU Directives, Consumer Product Safety Laws, etc.) to assure adherence to all requirements.
• Maintains thorough familiarity with internal SOPs to ensure adherence to internal policy and process requirements.
• Ensure product registrations / licenses are delivered and maintained to meet product launches, market expansion and product stewardship.
• Subject matter expert support during inspections by health authorities, or regulatory bodies.
• Translate project calendars into Regulatory key performance indicators (KPI’s) to assess and project resource needs.

Required Education, Skills and Experience

Environmental, Health and Safety Responsibilities (if applicable)

Quality Assurance Responsibilities (If applicable)

Work Environment

The salary range for this position is $168,000 - $222,000.   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.

LI-JB1

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.

Salary : $168,000 - $222,000