Regulatory Affairs Project Lead

3 weeks ago

Markham, Canada Kenvue Full time

**Regulatory Affairs Project Lead : 1-year contract**-2307008890W

Description

Kenvue, is currently recruiting for:
Regulatory Affairs Project Lead

For a 1- year contract with the possibility for extension. This position reports into Sr. Manager Regulatory Affairs and is based at Markham, ON.

**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.

Join us in shaping our future-and yours. Watch us here:
**What will you do**

The Regulatory Affairs (RA) Project Lead is responsible for providing management and leadership to plan, prepare, and execute high quality projects for Canada for over the counter (OTC) drug, natural health product, cosmetic and medical device products. You will interface with internal departments and company leadership, and externally with Health Canada, sponsors, and vendors. Your scope includes the development of regulatory strategies and submissions for filing to Health Canada and other regulatory responsibilities as required. You will help drive the success of the integration and creation of a stand-alone Consumer Health business in Canada
- Key Responsibilities
***
- Act as RA Lead to develop the regulatory plan and activities for the creation of a stand-alone Consumer Health company by representing RA at cross functional meetings and collaborating with key business partners and Health Canada and being the voice for RA.
- Lead the implementation of regulatory activities associated with the development of a stand-alone Consumer Health company by ensuring regulatory compliance with Health Canada regulations and alignment with company objectives.
- Lead all aspects of and obtain timely Health Canada approvals for products, product license / filings and GMP site license updates, through development of effective regulatory strategies, filing of quality submissions, effective problem solving and discussions with Health Canada officials.
- Lead projects and develop, review, and approve artwork and promotional copy to ensure regulatory compliance to internal and external requirements.
- Leverage resources, expertise, and knowledge across multiple projects to ensure attainment of project objectives within specified timelines.
- Collaborate and influence decisions in a highly matrixed organization, as well as in cross-functional team settings.
- Lead regulatory initiatives and change through participation in key industry associations, and/or direct interaction with regulatory authorities and professional associations.
- Develop and improve systems, processes, tools to enhance effectiveness and efficiencies of the RA department.
- May lead a small number of contractors or consultants.

**Qualifications**:
**What we are looking for**

Required Qualifications
- University degree in a scientific field (Life Sciences, Chemistry, Pharmacology/Toxicology or Pharmacy).
- Minimum 6+ years of experience in non-prescription pharmaceutical/NHP/cosmetic regulatory affairs.
- Demonstrated experience in acquiring approval of submissions and knowledge of the Canadian Food & Drugs Act and Regulations and Health Canada Policies and Guidelines.
- Canadian non-prescription drug, device, natural health product and cosmetic experience.
- Consumer healthcare industry regulatory experience.
- Excellent organizational, interpersonal, communication and decision-making skills.
- Excellent influencing skills and ability to work in an environment with ambiguity and change.
- Excellent strategic and negotiating skills.
- Strong attention to detail.
- Desired Qualifications
- Expertise in chemistry, manufacturing & control, and pharmacokinetics/bioequivalence submission requirement
- People management experience.
- Experience interacting with health authorities.
- Experience interacting with relevant trade associations or serving on trade association committees.
- Regulatory Affairs Certification (RAC).

**What’s in it for you**
- Competitive Benefit Package
- Paid Company Holidays, Paid Vacation, Summer Fridays & More
- Learning & Development Opportunities
- Employee Resource Groups

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportun

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