Manager, Cmc Regulatory Affairs

4 months ago

Toronto, Canada Johnson & Johnson Full time

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).

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

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.

**Qualifications**:
**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 fun

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