Regulatory Affairs Senior Specialist - 2307014669W

Description

Kenvue is currently recruiting for:

Senior Regulatory Affairs Specialist

This position reports into Regulatory Affairs Manager, SG, MY, BRU and is based at Singapore .

Who We Are

At Kenvue (https://kenvue.sharepoint.com/teams/PXEB-EB-assets/Shared Documents/2. Final Assets from Corporate Brand Design/kenvue.com/careers) , 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® that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact 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 (https://www.youtube.com/watch?v=XhsbOsBiX_M) .

What You Will Do

The position is responsible for:

• Manage new product registrations and product lifecycle management for cosmetic products, drugs (Over-the-counter medicines) and other consumer health products, upholding both internal and external quality and compliance standards.

Key Responsibilities

• Essential duties and responsibilities:

• Independently manage the documentation, compilation, preparation and submission of dossiers for new product registration, product amendment, product renewal and variation submissions as per Singapore requirement.

• Prioritize assignments and implement regulatory plan and co-ordinate multiple projects and activities in accordance with company objectives.

• Ensure timely submission and tight follow up till successful approval, delivering launch plan before or on time. Obtain timely renewal of product licenses.

• Receive CLCN and CMC variations from the AP RMC and identify if submission to the local Health Authority is required.

• Review and provide regulatory advice for product labels/artworks and promotional marketing materials to ensure they are in line with business requirements, compliant to internal process and local requirements/regulations.

• Strategize and work collaboratively with Global/Regional Regulatory, Commercial, Quality, Supply Chain, R&D teams to deliver timely and commercially advantageous license approvals and ensure regulatory compliance and marketing continuity.

• Updating product registry in all relevant internal systems and trackers.

• Monitor relevant regulatory developments in Singapore & provide update to Consumer RA Manager in timely manner and update the relevant regulatory intel system.

• Assist to research on regulatory related information or updates, compile and presented to RA Manager whenever required

• Advise the local team on dealer’s license and GDP requirement.

• Support Consumer RA Manager with any other task as and when required.

• Engage with external stakeholders, e.g. HSA, SAPI, CTFAS for queries, requests, or initiative

Special Requirement:

• To function as the company pharmacist, with the authority to hold the specific licenses required for the legal function of the business with the health authority.

Qualifications

What We Are Looking For

Required Qualifications

• Degree in pharmacy or equivalent, must be a registered pharmacist with the Singapore Pharmacy Council

• Must be a Singaporean or Singapore Permanent Resident

• Good command in spoken and written English.

Desired Qualifications

• Good interpersonal, presentation and effective communication skills.

• Analytical, meticulous and problem-solving skills including decision-making for operational issues.

• Time management.

• Able to work independently, multi-task and perform in a fast-paced environment.

• Able to work well with others in teamwork and with other functions.

What’s In It For You

• Competitive Benefit Package

• Paid Company Holidays, Paid Vacation, Volunteer Time.

• Learning & Development Opportunities

• Employee Resource Groups

• This list could vary based on location/region

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.

Primary Location Asia Pacific-Singapore-Singapore-Singapore

Job Function Regulatory Affairs

Req ID: 2307014669W