Associate Manager Regulatory Affairs

2 weeks ago

Markham, Canada Kenvue Full time

**Associate Manager Regulatory Affairs**-2307002136W

**Description**

Kenvue is currently recruiting for Associate Manager Regulatory Affairs. This position reports into the Associate Director Regulatory Affairs and is based out of Markham, Ontario.

At Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), 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.

Join us in shaping our future-and yours.

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This position will work closely with cross-functional partners to develop regulatory strategies and various submission packages throughout the development process and through filing and post approval, execute CMC regulatory strategies with internal research and development, and other technical/scientific colleagues. Collaborate and influence decisions in a highly matrixed organization, as well as in cross-functional team settings. This position provides direction regarding the regulatory requirements of new and marketed natural health and drug products, as well as helping support the implementation of long term companywide regulatory strategies and operating principles/practices.

**Responsibilities**
- Work in close collaboration with the key stakeholders in the filing of quality submissions, effective problem solving and negotiations with health authority officials.
- Manage regulatory submissions for new products, manage changes to existing products and maintenance of products, in compliance with applicable government regulations and company standards.
- Attend GMP training on the schedule designated for my role and as appropriate for my role
- Adhere to strict compliance with procedures applicable to my role.
- Exercise the highest level of integrity in the tasks that I perform
- Participate as an SME in internal and health authority audits.
- Provide support for Regulatory Operations through management of databases and submission publishing.
- In a timely and prompt manner, identify, report, and seek correction for deviations noted in my workplace.
- Embrace a behavior of employee involvement and commitment to doing the job right the first time.
- Ensures adherence to standard operational procedures for the timely approval of new drug products and regulatory support of marketed drugs and other products
- Influence the external environment by anticipating and proactively affecting changes to key law, regulations and international standards keeps current with the local regulatory environment, guidance documents, industry best practices and historical submission experience in order to provide assessments of the impact of new and changing regulations on the company's research and development programs to management and cross-functional partners.
- Develop and maintain scientific expertise concerning assigned therapeutic and/or functional area in order to advise the business on new opportunities, help develop new claims and be aware of (and be able to respond to) emerging competitive, regulatory and NGO threats.
- Works with management to define and provide definitive overall regulatory strategies.
- This position will author and review many sections of a variety of regulatory submissions.
- This position is responsible for providing regulatory guidance to new product development (NPD) teams and facilitating implementation of NPD regulatory strategies including required NA submissions
- Works with management to coordinate activities related to the submission, approval, and product life cycle requirements
- Establishes accountability for the preparation of necessary reports, documents, and other written materials.

**Qualifications**
- A minimum of a bachelor’s degree in relevant health-related scientific discipline or an advanced degree in a related field is preferred.
- A required a minimum of 6 years of OTC CMC/RA or related experience in the Rx/OTC environment including experience with eCTD submissions, natural health, Canadian Old/New drug, NDA products and required knowledge of Module 3 Quality dossier content, including experience authoring CMC sections. General regulatory affairs franchise experience is an asset.
- Knowledge/familiarity with Health Canada/FDA and Global regulatory registration of drugs is required.
- Excellent verbal and written skills and the ability to work effectively in a team-oriented, matrix environment is required.
- Experience interacting with health authorities is preferred.
- The position must have the ability to work independently, manage several complex projects

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