Director, Regulatory Affairs, Janssen Inc., Toronto, ON-3973140212
Description
As a member of the Johnson & Johnson Companies, Janssen Inc. is the pharmaceutical sector that is dedicated to addressing and solving the most important unmet medical needs in pain management, psychiatry, oncology, psoriasis, virology, anemia, attention deficit hyperactivity disorder, dementia, gastroenterology and women's health. Driven by our commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative ideas, products and services to patients around the world.
Janssen has a strong Immunology Franchise delivering breakthrough therapies to patients with rheumatoid arthritis, irritable bowel syndrome and psoriasis. Key products include Remicade, Simponi and Stelara. Janssen owned the largest immunology franchise in Canada and has proven record in the development and marketing of these significant products.
The Director, Regulatory Affairs (RA), Immunology will be responsible for the Immunology Portfolio Management, building regulatory strategy to support business growth and the company strategic plan. Immunology is the biggest franchise for Janssen and also blessed with a rich pipeline both in early and late development. The individual will direct a team of regulatory professionals to lead the implementation of RA strategies to establish optimal regulatory positions for all new indications for products in our current franchise and also responsible for development of RA strategies for our new products in the Immunology Pipeline.
Key Responsibilities/Accountabilities
Provide leadership, strategy and technical direction to ensure optimal approval of Janssen
Immunology NDS and SNDS with timing aligned with local business strategy and global timeline.
To build strong relationship with Health Canada immunology reviewers and policy maker to establish credibility of Janssen as a high science partner.
To influence Health Canada to adopt high-science methodology in their review and to ensure alignment with other more progressive global regulatory authority such as FDA in the review and approval of immunology drugs. A strong relationship with BGTD of Health Canada will be an asset.
To liaise with Health Technology Assessment to ensure optimal alignment of strategy and timing for regulatory approval and reimbursement
To assure the following key activities are aligned with Global timeline, business objectives of the local operating company and also and in compliance with F&D Act and regulations:
Timely filing and approval of key New Drug, Supplemental, and Notifiable Change submissions
Competitive product labeling
Management of safety issues and associated risk communications to HCP's
Manage core Regulatory Activities
Management and development of Regulatory Managers/Associates
Ensure ongoing regulatory compliance for Marketed Products
The individual will establish strong relationships with Health Canada to ensure optimal implementation of local regulatory strategies
The individual will work closely with (dotted line relationship) Global Regulatory Teams to facilitate all regulatory activities related to products from global pipeline.
Qualifications
PhD or M. Sc. in Biological Science or Pharm D with experience in immunology
Minimum 8 - 10 years related experience in Reg. Affairs
Ability to influence and negotiate with Health Canada and business partners
Excellent communicator and team player
Performs well under pressure
Strong interpersonal and verbal communication skills
Ability to link projects strategically to business priorities
Proven leadership skills to facilitate teamwork, innovation and problem-solving
Strong analytical and critical thinking skills
Demonstrated people skills including negotiation, coaching/mentoring, influencing, and motivating
Strong writing skill (scientific/dossier) an asset
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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.
J2W:LI NA
Primary Location:North America-Canada-Ontario-Toronto
Organization: Janssen Inc. (7710)
Job Function: Regulatory Affairs
Description
As a member of the Johnson & Johnson Companies, Janssen Inc. is the pharmaceutical sector that is dedicated to addressing and solving the most important unmet medical needs in pain management, psychiatry, oncology, psoriasis, virology, anemia, attention deficit hyperactivity disorder, dementia, gastroenterology and women's health. Driven by our commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative ideas, products and services to patients around the world.
Janssen has a strong Immunology Franchise delivering breakthrough therapies to patients with rheumatoid arthritis, irritable bowel syndrome and psoriasis. Key products include Remicade, Simponi and Stelara. Janssen owned the largest immunology franchise in Canada and has proven record in the development and marketing of these significant products.
The Director, Regulatory Affairs (RA), Immunology will be responsible for the Immunology Portfolio Management, building regulatory strategy to support business growth and the company strategic plan. Immunology is the biggest franchise for Janssen and also blessed with a rich pipeline both in early and late development. The individual will direct a team of regulatory professionals to lead the implementation of RA strategies to establish optimal regulatory positions for all new indications for products in our current franchise and also responsible for development of RA strategies for our new products in the Immunology Pipeline.
Key Responsibilities/Accountabilities
Provide leadership, strategy and technical direction to ensure optimal approval of Janssen
Immunology NDS and SNDS with timing aligned with local business strategy and global timeline.
To build strong relationship with Health Canada immunology reviewers and policy maker to establish credibility of Janssen as a high science partner.
To influence Health Canada to adopt high-science methodology in their review and to ensure alignment with other more progressive global regulatory authority such as FDA in the review and approval of immunology drugs. A strong relationship with BGTD of Health Canada will be an asset.
To liaise with Health Technology Assessment to ensure optimal alignment of strategy and timing for regulatory approval and reimbursement
To assure the following key activities are aligned with Global timeline, business objectives of the local operating company and also and in compliance with F&D Act and regulations:
Timely filing and approval of key New Drug, Supplemental, and Notifiable Change submissions
Competitive product labeling
Management of safety issues and associated risk communications to HCP's
Manage core Regulatory Activities
Management and development of Regulatory Managers/Associates
Ensure ongoing regulatory compliance for Marketed Products
The individual will establish strong relationships with Health Canada to ensure optimal implementation of local regulatory strategies
The individual will work closely with (dotted line relationship) Global Regulatory Teams to facilitate all regulatory activities related to products from global pipeline.
Qualifications
PhD or M. Sc. in Biological Science or Pharm D with experience in immunology
Minimum 8 - 10 years related experience in Reg. Affairs
Ability to influence and negotiate with Health Canada and business partners
Excellent communicator and team player
Performs well under pressure
Strong interpersonal and verbal communication skills
Ability to link projects strategically to business priorities
Proven leadership skills to facilitate teamwork, innovation and problem-solving
Strong analytical and critical thinking skills
Demonstrated people skills including negotiation, coaching/mentoring, influencing, and motivating
Strong writing skill (scientific/dossier) an asset
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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.
J2W:LI NA
Primary Location:North America-Canada-Ontario-Toronto
Organization: Janssen Inc. (7710)
Job Function: Regulatory Affairs