Manager - Regulatory Affairs

Description

Kenvue is currently recruiting for:

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-AID® 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 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 ...