Description
Kenvue is currently recruiting for:
Regulatory Affairs Specialist
This position reports into GRA CMC Regulatory Affairs Manager and is based at Mexico City.
Who we are
At Kenvue, part of the Johnson & Johnson Family of Companies, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® —are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.

What you will do
The Regulatory Affairs Specialist is responsible for ensuring compliance with regulatory agency regulations and interpretations, preparing responses to regulatory agencies' questions and other correspondence, and organizing and maintaining reporting schedules for new drug application and investigational new drug applications, this is a fixed term 12 months position.
Key Responsibilities:

• Develop and maintain regulatory strategies and submissions for new products and changes to existing products in alignment with industry standards and regulations.

• Collaborate with cross-functional teams to ensure compliance with regulatory requirements throughout the product development lifecycle.

• Provide guidance and support to internal stakeholders on regulatory matters, including labeling, advertising, and promotional materials.

• Stay up-to-date with changes in regulations and industry standards, and communicate potential impacts to the organization.

• Contribute to the development and implementation of quality systems and processes to ensure compliance with regulatory requirements.

• Participate in regulatory agency inspections and audits, and assist with the resolution of any findings or observations.

• Develop and execute regulatory strategies to ensure compliance with global, regional, and local regulations and guidelines

• Collaborate with cross-functional teams to plan, conduct, and manage regulatory activities to meet department and company objectives

• Prepare and compile high-quality regulatory submissions, responses to regulatory agencies questions, and other correspondence in accordance with regulatory agency regulations and guidelines

• Review and approve artwork and promotional copy material to ensure regulatory compliance

• Develop and maintain reporting schedules for new drug application and investigational new drug applications

• Provide solutions to complex problems and ensure quality and compliance in all actions

• Maintain and archive regulatory documentation in accordance with regulatory agency regulations and guidelines

• Present status updates on product/project activities to key internal/external stakeholders

• Assist in the development of best practices for Regulatory Affairs processes

Qualifications
What we are looking for
Required Qualifications.

• Bachelor's degree in a scientific or healthcare-related field

• 2-4 years of experience in regulatory affairs

• Strong knowledge of COFEPRIS and FDA regulations and guidelines, as well as experience with international regulatory requirements

• Excellent communication and interpersonal skills

• Detail-oriented with strong organizational and project management skills

• Ability to work independently and prioritize tasks in a fast-paced environment

• Experience with medical devices or pharmaceuticals is preferred

• Excellent computer skills in Word, Excel, Power Point, Email, and Internet

• Attention to detail with excellent documentation skills and ability to continuously anticipate and solve problems

Desired Qualifications

• Experience handling regulatory data on regulated products such as OTC Drugs, Cosmetics, and Medical Devices

• University/Bachelor's Degree or Equivalent in a related field

• Experience with Regulatory processes such as Drug Listing, IDMP, and Periodic Safety Reporting

• Strong and effective interpersonal skills, with a team-oriented and collaborative approach geared towards providing solutions and consistent delivery

• Ability to multi-task and deliver high-quality work under pressure to deliver results

• Ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans and strong track record seeking and incorporating stakeholder feedback

What’s in it for you

• Annual base salary for new hires in this position ranges from $XXX to $YYY. This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

• 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.

Primary Location Latin America-Mexico-Distrito Federal-Mexico City

Job Function Regulatory Affairs