Director, Global Regulatory Affairs
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We’re a company that genuinely cares about our people, our products, our consumers and the environment.
Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.
United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.
The Director, Global Regulatory Affairs serves as the Regulatory leadership position for the company. They act as primary liaison between the Company and Local, State, Federal and International regulatory agencies with jurisdiction over company products including Field Action and Notices for Marketed Products. The Director also provides advice and notice to the Company for new or developing global regulatory requirements, compliance with existing global regulations, and on regulatory constraints in pursuing development of new products and maintaining marketability of existing products world-wide. The Director oversees critical regulatory responses to global Regulatory Authorities and develops regulatory strategies specific to product related regulatory matters where distributed world-wide – compliance, auditing, labeling, and claims.
The position will oversee a global staff of 6 that manages the efforts of all Church & Dwight Regulatory Associates (15+) world-wide and guides all pertinent filings (e.g., 510(k)s, CE Marks, clinical studies, and Marketing Authorizations) with International Regulatory Agencies for Church & Dwight’s Global Portfolio. The Director will determine the regulatory status of new claims and whether such claims require further or additional filings. In addition, the Director has principal oversight of the Regulatory review for all diligence activity related to M & A activity.
Role Accountabilities and Responsibilities
- Defines and executes regulatory strategies against diverse company portfolio development in collaboration with R&D executive leadership, and the Quality, Clinical, Finance and Legal teams
- Member of R&D Leadership Team and on International Business Leadership Team.
- Primary interface/liaison with Global regulatory agencies (e.g., FDA, EPA, HC, EC, Competent Authorities, Ministries of Health, etc.) on company critical matters.
- Ensures worldwide regulatory strategies are clearly defined, supported, and implemented in the development and commercialization of all product lines.
- Serves the Company as the regulatory representative on Regulatory Affairs committees of key trade associations to promote the company position and aid in influencing potential legislation.
- Interprets and internally communicates, in a timely manner, critical global government agency policies, procedures and regulations, both existing and newly published, to maintain/ensure compliance with regulatory standards and to facilitate regulatory approvals.
- Oversees Corporate Chemicals Policy, identifying and eliminating Chemicals of Concern across the product portfolio. This position also coordinates strategic direction for Chemicals policy, and corporate goals.
- Organizes and directs project regulatory assignments as related to product acquisitions/licensures and investigational and marketed products.
- Directs product submission strategy and prepares or directs, reviews and edits documents intended for regulatory submissions globally (e.g., Submissions, clinical studies, Regulatory Inspection observations and responses) and internal documentation of regulatory positions/findings.
- Determines what information, data and/or other information are required to respond to or fulfill global regulatory agency requests (e.g., Additional Information letters, etc.).
- Reviews and/or directs the regulatory review and approval of promotional materials and product labeling.
- Improves processes to inform cross functional leadership of financial and regulatory risks and opportunities related to all of the foregoing, by working closely with Marketing, R&D, Global Supply Chain, and other Quality System representatives. Requires an understanding of the marketplace and where the Company’s product and marketing approach fits in.
- Critical member of R&D leadership team effectively collaborating with colleagues to ensure corporate and R&D goals are aligned, and that the department is delivering on its strategic objectives.
- Provides leadership and vision by interpreting and clarifying regulatory initiatives and mandates, discovering emerging trends and providing the processes necessary to meet ever-increasing prospects and expectations
Education and Experience
- Diversity of experience across categories, having worked in some higher end areas and across spectrum (e.g., device, OTC, EPA regulated, cosmetics).
- Extensive knowledge and experience in designing regulatory strategies and submissions of product registrations across an array of categories
- International experience (International company role and/or regional responsibilities outside US).
- Knowledge of Global Regulations
- Prior experience working with Regulatory Affairs Committees at Industry Associations (CHPA, AdvaMed etc.), desirable.
- Experience in related field (such as product stewardship, quality assurance, quality control) preferred.
- Bachelor’s degree in scientific discipline from an accredited institution. MS or PhD degree desirable.
- 15+ years’ experience in regulatory affairs, with at least 5 years leading a Global Regulatory team.
Skills and Competencies
- Demonstrated strong leadership, client development, communication, analytic, organization and implementation skills
- Highly experienced in recruiting, hiring, retaining, managing, and developing strong teams.
- Broad business orientation and ability to work effectively understanding a cross functional perspective.
- Strong influence and negotiating skills.
- Effective and concise communication skills with all corporate levels.
- Strong strategic thinking and execution skills
- Ability to influence direction of complex regulatory issues helping others make important and correct decisions
- Proven agile, practical, and flexible leader with results orientation. Demonstrates sense of urgency
- Adept at interacting cross-functionally and with executive leaders
- Business focused with a strong work ethic and a passion for understanding the business and contributing in a meaningful way to the corporate strategy
- Highly resilient with the capability to succeed in a fast-paced environment
- Capability to make fast yet well-founded decisions on a variety of multidisciplinary issues.
Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.
For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/
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DIVERSITY At Church & Dwight
Church & Dwight strives to create an environment where everyone feels free to bring their authentic self to work every day.
We win when we respect every employee for who they are – regardless of gender, age, race, ethnicity, religion, disability, veteran status, sexual orientation or any other differences. We believe that our employees’ contributions are richer because of their diversity. We aim to be a diverse, inclusive and equitable company and are determined to build a culture where people have the power to win together.
CULTURE At Church & Dwight
We care - about our people, our products, our consumers and our environment. To honor these priorities, we’ve built our culture around the tenants of courage, determination and team spirit. We’re united by our small company feel and inspired by opportunities to make our mark.Learn More
Equal Employment Opportunity for the Disabled At Church & Dwight
As an equal opportunity employer, Church & Dwight is committed to providing access and opportunities to individuals with disabilities. Applicants who require accommodation in the job application process may contact 877-809-8449 or email their resume and cover letter to email@example.com. Please note that these options are available only to those needing an accommodation because of a medical condition or disability. All email submissions should include “Accommodation needed” in the subject line as well as information related to the specific position you are interested in (requisition number, job title, location, etc.). Church & Dwight will not respond to inquiries made to firstname.lastname@example.org or 877-809-8449 that are not related to accessibility of the online application system by persons with medical conditions or disabilities. To review Church & Dwight’s Equal Opportunities Employer Policy, click link below.Learn More