Johnson & Johnson is currently seeking a Regulatory Affairs Manager, Chemistry, Manufacturing, and Control (CMC) to be located in Toronto, Ontario under the flexible working model (at least 3 days in office).
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.
The Regulatory Affairs CMC (RA CMC) Manager contributes to the development of Canadian Chemistry, Manufacturing and Control (CMC) regulatory strategies. The primary responsibility is to provide regulatory CMC support to the Canadian Local Operating Company for New Drug Submissions, Supplements, and other post approval changes for assigned small and large molecule products
The Manager, CMC Regulatory Affairs serves as a Canada subject matter expert for CMC regulatory affairs. The Manager will play a critical leadership role in coordinating, compiling, and managing the CMC specific sections of the approval process for submissions to Health Canada for global products as well as local Canadian initiatives. In collaboration with the other CMC regulatory professionals in Canada, the Manager is also responsible for updating global systems to ensure the Canadian specific regulatory details are documented for each type of submission.
This role works with Regulatory Affairs and Corporate Quality to ensure the quality information complies with the Health Authority requirements. This individual will act as an internal expert on RA CMC projects and works closely with global partners in the areas of pre- and post-approval submissions, with a focus on maintaining regulatory compliance with Canadian laws and regulations, as well as corporate policies and procedures.
Key Responsibilities:
- Leads the preparation of CMC regulatory dossiers (New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs) and Notifiable Changes (NCs)) for submission to Health Canada based on the provided core packages. Represents CMC Regulatory Affairs on Cross Functional Teams by providing regulatory expertise from a Canadian perspective and input to ensure the NDS and the post-approval filing strategy meets Health Canada regulatory requirements over the various lifecycle stages of multiple assigned products.
- Actively participates on Global Regulatory Team(s) to develop Canada submission plans that comply with local regulatory requirements and commitments.
- Develop and execute Canada CMC regulatory strategies in conjunction with global teams for drug products, such as drug/device combinations, small molecule drug products including parenterals, large molecule drug products like mAbs, cell and gene therapy products and other new modalities.
- Provides accurate regulatory assessments of chemistry manufacturing and control changes to teams and executes regulatory planning for post approval submissions and ensures CMC regulatory strategy is in alignment with the local and global regulatory strategy.
- Ability to compile high level scientific summaries, justifications in preparation of regulatory submissions and responses to Health Authority questions.
- Assures connectivity to the overall regulatory strategy through partnership and communication with local Therapeutic Area Regulatory Affairs and Global CMC Regulatory Affairs Leader.
- Review CMC data packages for regulatory dossiers for Canadian submissions throughout the product lifecycle.
- Develop and update contingency plans for issues that may affect registration, regulatory compliance and the continued lifecycle management of the products in scope.
- Support the resolution of emerging issues (e.g. quality findings) and the associated risk communications to business partners.
- Effectively communicate with Health Canada; build positive relationships and maintain good rapport and credibility. When appropriate, lead or support meetings with Health Canada under supervision of a senior member of the department.
- May serve as a Single Point of Contact (SPOC)/Subject Matter Expert (SME) on internal and external teams to proactively influence regulatory and quality policy and practice on specific areas of CMC regulatory expertise.
- Participate in and conducts due diligence/licensing evaluations as necessary.
- Drive a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management in a timely manner.
- May provide oversight of assigned supporting staff.
Education:
- A minimum of a Bachelor's degree in Chemistry, Biological, Pharmaceutical or related sciences required. An MS, Ph.D., or Pharm. D. degree is preferred.
Experience and Skills:
Required:
- A minimum of 6 years of Regulatory Affairs pharmaceutical or health care industry experience or equivalent experience
- Solid knowledge of Biology, Chemistry and/or engineering fundamentals relevant to pharmaceutical industry
- Knowledge and experience with Health Canada regulations
- Understanding of the Pharmaceutical or equivalent regulated industry, Quality Systems and Change Control procedures
- A minimum of 2 years of experience developing or contributing to regulatory strategies in regulatory affairs or a related function (i.e. R&D, quality compliance)
- Solid proficiency with MS Office suite and experience with business software applications that support document management and event tracking
- Strong interpersonal, verbal and written communication, negotiation and partnering skills
- Ability to work effectively in cross-functional teams
- Track record managing multiple projects simultaneously
Preferred:
- Experience leading interactions with Health Authorities under supervision of a senior member of the CMC RA staff
- Experience in biologics, product development/LCM of the large molecules
- Experience directly writing submission documents that support clinical trials, marketing applications, or with lifecycle management
Other:
- This role may require up to 10% travel.
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 opportunity to achieve their potential.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com
