Job Description

Description
Kenvue is currently recruiting for:
Senior Manager Regulatory Affairs
This position reports into Head Regulatory India and is based at Mumbai, India
Who we are
At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson's and BAND-AIDxc2xae Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information, click here .
What you will do
The Senior Manager Regulatory Affairs (Self Care-Drug / Essential Health) leads a team responsible for the development of regulatory strategies across India providing regulatory input and technical guidance on local regulatory requirements to product development teams.

• Manages the regulatory deliverables for drug, cosmetic, medical devices, commodities &/or any similar product within their geographical and/or brand area of responsibility

• Ensures consistency of regulatory positions within the different segment brands in collaboration within the team

• Develops strong partnerships with R&D, Franchise (Marketing) and local business

• Manages the maintenance of the current products throughout their whole lifecycle

• Represents the Regulatory Affairs function as appropriate within the Franchise.

Key Responsibilities:
Regulatory Strategy

• Provides regulatory input and technical guidance on local regulatory requirements to product development teams

• Supports the business initiatives, by strengthening propositions, influence and approve the product portfolio thorough "governance" forums.

• Provides regulatory risk-based assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non-clinical data are consistent with the required regulatory requirements and support the proposed product claims.

• Participates in cross-functional project teams to define RA resources, development program requirements and risks

• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.

• Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at regional level.

Regulatory Compliance

• Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.

• Communicate changes to appropriate management and cross functional experts as appropriate and implement locally

• Ensure that all products comply with local regulatory and quality system requirements.

• Ensures quality and compliance in all actions.

• Leads inspections and/or challenges by Authorities and competitors, proposing defence angles in collaboration with relevant experts and framing them with a smart approach.

• Participate in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs and working instructions

• Ensures that the enterprise Regulatory systems are accurate and fully maintained

• Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally

• Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives

• Manage and support internal and external audits and inspections in collaboration with quality function

• Supports crisis management / PR matters as related to regulatory affairs

Regulatory Advocacy

• Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company's areas of interest.

• Actively participate in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at local level or regional level (if relevant).

Team Management:

• Provides technical and leadership development as appropriate.

• Monitors progress of applications of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties.

• Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility

• Works with strategic direction to perform with independent judgment and execution which directly impacts the operational results of the business unit.

• Represents Regulatory Affairs on cross-functional product/project teams and provides regulatory advice.

• Manages work groups and provides direction.

• Provides day-to-day instructions and suggested training activities to direct reports.

• Applies organizational understanding and awareness in decision making.

• Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts.

What we are looking for

• Relevant Bachelor's Degree or higher

• Expertise across a broad spectrum of Regulatory classifications including Cosmetics, Commodities and/or Medical Devices

• Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory

• solutions throughout the product lifecycle.

• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance

• Leadership and coaching skills with experience of people development

• In-depth knowledge of the business, organizational goals, Regulatory Affairs function, and cross functional business partners to make informed business decisions and create and execute business strategies. Ability to represent RA function on cross-functional teams and governance forums.

• Able to work effectively in a multi-cultural, highly matrixed organization

• Experience in cultivating and leveraging strategic networks and partnerships

What's in it for you

• Competitive Benefit Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
• Learning & Development Opportunities
• Employee Resource Groups
• This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. '