GLOBAL REGULATORY DIRECTOR JOB DETAILS | EDGEWELL PERSONAL CARE BRANDS, LLC

Edgewell is not just a company, but a vibrant global community of  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.
., 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 Bachelor’s degree in Regulatory, Law, Science or related field.
Master’s, or advanced degree/ certification preferred.
Minimum of 15 years of related experience within a regulated consumer products environment.
Sound knowledge of the consumer products industry.
Experience with OTC drug regulations for FDA, Health Canada, and TGA.
Medical devices’s regulations in the USA, Canada, and Mexico.
Experience with global cosmetic regulatory requirements.
Sound knowledge of Canadian Registration Processes and NAFTA is desired.
Knowledge of global regulatory framework for consumer safety and pharmacovigilance.
Proven ability to communicate, influence and establish effective networks across diverse teams at all levels of the organization.
Strong analytical skills.
Strong sense of urgency and ability to continuously reprioritize.
Ability to manage multiple activities simultaneously.
High degree of attention to detail, organization and timely follow-up.
Excellent interpersonal skills, with ability to interact / communicate effectively across various levels within the organization.
Demonstrated ability to effective lead people and perform administrative and budgetary duties related to department management.
Environmental, Health and Safety Responsibilities (if applicable) Be aware of and follow the Environmental Policy and EH&S work instructions/procedures that apply to the job.
Perform every job safely, for the benefit of self, co-workers, contractors, and for the protection of facilities.
This includes the use of required personal protective equipment and use of safety equipment as well as safe work practices.
Immediately report every job-related injury or illness, regardless of severity, to a supervisor.
Assist in investigating incidents as directed by your supervisor.
Take necessary actions to correct or stop any unsafe conditions or practices.
Actively participate in safety meetings and training.
Review Material Data Sheet instructions before working with any chemical product.
Excellent negotiating and influencing skills, and ability to work across multiple functional areas, with a true sense of urgency in responding to delivering on challenges.
A high sense of ethics and integrity with an approachable and pragmatic style to communication and application   Quality Assurance Responsibilities (If applicable) Colleagues are responsible for their own quality and that of colleagues within their span of control.
Colleagues are responsible to follow all established Quality procedures and instructions.
Notify supervision for corrective action if and when defects are found and/or parts/processes do not conform to specifications.
Work Environment Some travel is required.
The salary range for this position is $.
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.