Regulatory Affairs Lead
Bridgewater, New Jersey
Regulatory Lead, U.S. Regulatory Affairs CHC
Category Head, U.S. Regulatory Affairs CHC
Inspiring professional who will leverage his/her regulatory experience and commercial awareness to proactively contribute to CHC business growth.
SCOPE OF RESPONSIBILITIES:
- The successful candidate will possess strong communication, negotiation and influencing skills.
- He/She will be at ease working in a matrix environment and display the necessary multicultural sensitivity in such a Global context
- He/She will bring creative & innovative ideas to the table to support the global regulatory therapeutic leads.
- He/She will work with maximal autonomy under the supervision of the associated Category Head
- Provide assistance to Product Development in identifying new product opportunities, generate product evaluation summaries and novel regulatory development pathways
- Responsible for working with marketing to develop new advertising, concept review, comment and approval, competitive challenge research/responses. Assists in drafting “Competitive Challenges” when requested.
- Life cycle management of NDA & OTC monograph drugs, dietary supplements, cosmetics, foods, pesticides and medical devices. Will interact with FDA and with external Trade Associations.
- Maintain claim substantiation database for each marketed product; responsible for ensuring all support documents are adequate prior to claim approval.
- Responsible for review and approval of all advertising and promotional materials for assigned products.
- Supports and conducts research into the regulatory requirements for the registration of Class I and II medical device, combination medical device/OTC, and OTC monograph drug products domestically (U.S.) leading to preparation and submission of FDA notification as needed, and supports international device registrations as needed.
- Assists in the analysis and interpretation of government medical device regulations.
- Review and approves labeling and advertising for OTC monograph drugs, medical devices, cosmetics and dietary supplements.
- Provides accurate and timely risk assessments for new product concepts and advertising materials.
- Represent company alone or with Sr. Management at Health Agency meetings for assigned products. Oversee the planning and conduct of meetings with regulatory agencies as appropriate. Initiate/oversee and respond to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products.
- Ensure that all documents to be submitted to regulatory agencies have been evaluated to assure completeness, scientific accuracy, regulatory compliance with global and/or local submission standards and are organized in a manner to facilitate agency review.
- Supervise and coordinate all regulatory activities required for submissions to regulatory agencies for assigned products.
- Provide company with current and proposed regulatory, scientific and pertinent legal issues including analysis of potential impact on the business.
- Provide regulatory strategy and intelligence for due diligence and business development initiatives.
- Serves as an educational resource to both internal and external customers.
- Research competitive product approval status and emerging FDA requirements to support timely approval of submissions.
- Contributes to interdepartmental projects and supports the provision of medical, scientific, and technical information.
- Provides assistance and represents Regulatory Affairs by participating as a team member on approved projects and programs.
- Works with various regulatory personnel at all levels to solve regulatory issues and support other business unit objectives.
- Supports the product launch and maintenance of NDA & OTC drugs, cosmetic, medical device and dietary supplements
- Acts as International Regulatory liaison lead with Sanofi affiliates to coordinate and provide registration support documents. Also works closely with Canada CHC RA specifically as part of the North America region.
EDUCATION or EXPERIENCE:
- Minimum B.S.; M.S., Pharm D, MD, PhD or equivalent preferred
- Regulatory Certification (RAC) preferred
- Minimum 5-8 years in Regulatory Affairs
- Demonstrated success in developing regulatory strategies in OTC environments; possesses a strong knowledge of the regulatory requirements to support the region
- Fluent English required; additional languages desirable
- Recognized expert in managing matrix teams and partnering with cross functional teams at a highly strategic level
- Act for Change
- Cooperate Transversally
- Strive for Results
- Commitment to Customer
- Think Strategically
- Lead Teams
- Develop People
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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