Regulatory Lead

• Location: Tokyo

About the job

DEPARTMENT:

Regulatory, Science Hub Japan

REPORTS TO:

Head of Regulatory

BASIC FUNCTION:

Inspiring professional who will leverage his/her regulatory experience and commercial awareness to proactively contribute to CHC business growth.

At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.

SCOPE OF RESPONSIBILITIES:

• Possess strong communication, negotiation and influencing skills.
• At ease working in a matrix environment and displays the necessary multicultural sensitivity in a Global environment
• Able to develop strong networks and influence internal and external stakeholders
• Drives creative & innovative ideas to support the category.
• Accountable for a category yet shares the responsibility of leadership within the entire Regulatory, Science Hub Japan team which may involve working across categories. Functions on behalf of the Regulatory and CHC enterprise.
• Leads, motivates and develops team members

Main responsibilities:

DUTIES:

• Manage regulatory activities for development and marketed products (through third parties if applicable) including business license renewals/changes/registrations and take the lead in PMDA consultation, NDA and PCA/MCN submission and review process management.
• Provides leadership to and along with New Product Development, including Rx-to-OTC switches, and Commercial in identifying new product and claims opportunities, regulatory enabling opportunities, generate product evaluation summaries and novel regulatory development pathways that will ultimately drive business growth.
• Leads HA interactions with cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy, HA submission, labeling and advertising.
• Works within CHC and externally across Japan Trade Associations to identify and solve for issues and strategic CHC aligned opportunities to promote self-care.
• Responsible for working with marketing to develop new advertising, concept review, comment and approval, competitive challenge research/responses.
• Lead the regulatory strategy and execution efforts with senior R&D and commercial leaders and their staff for both new products/claims as a well as the life cycle management of potentially any/all regulatory classes (drugs, quasi-drugs, food (supplements) and food with functional claims (FFC), cosmetics and medical devices).
• Develop and 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 advertising and promotional materials
• Leads the analysis and interpretation of regulations.
• Review and approves labeling and advertising.
• 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 regulators represent the CHC aligned strategy, are complete, accurate, compliant with global and/or local submission standards and are organized in a manner to facilitate agency review.
• Ensure current and proposed regulatory, scientific and pertinent legal issues including analysis of potential impact are made present to the business.
• Provide leadership for 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 HA requirements to support timely approval of submissions.
• Contributes to interdepartmental projects and supports the provision of medical, scientific, and technical information.
• As a leader, works with various regulatory personnel at all levels to solve regulatory issues
• Works hand-in-hand with our Regulatory colleagues, where relevant, on any/all product issues & opportunities.

About you

EDUCATION or EXPERIENCE:

Education:

• Minimum B.S.; M.S., Pharm D, MD, PhD or equivalent preferred
• Minimum 5 years in Regulatory Affairs, including leadership roles.

Experience:

• Demonstrated success in developing regulatory strategies in OTC environments, including Rx-to-OTC switches; possesses a strong knowledge of the switch scheme and the regulatory requirements across any regulatory application classification
• Experience in shaping the regulatory environment through active lead in trade associations
• Recognized expert in managing matrix teams and partnering with cross functional teams at a highly strategic level

Competencies:

• Act for Change
• Cooperate Transversally
• Strive for Results
• Commitment to Customer
• Think Strategically
• Lead Teams
• Develop People

Language

• Japanese: Native level
• English: Proficient in Business English

Why choose us ?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!