HireDiversity

Toronto, ON, CA

Director, Regulatory Science & Policy - Janssen, Inc. - Toronto ON-7753121022

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.

As a result of a business expansion, Janssen Inc. is looking to hire a Director, Regulatory Affairs Science & Policy that is located in Toronto, Ontario.

Job Overview:

Provide leadership, strategy and technical direction to ensure Janssen would align optimally with Health Canada regulations and policies with special focus on subsequent entry biologics. Influence Health Canada and other regulatory authorities and reimbursement agencies where appropriate to embrace the challenges in the evaluation of subsequent entry biologics. The successful candidate will be a standing member of the subsequent entry biologics team and provide technical and regulatory knowledge in all key disciplines essential for strategic differentiation between subsequent entry products to innovator products including structural comparability, PK/PD, clinical trial design, immunogenicity, post-marketing evaluation and interchangeability

Major Responsibilities:

Develop programs to influence key regulatory agencies to embrace a high science approach in the evaluation of subsequent entry biologics and biosimilars recognizing complexities in chemistry and manufacturing; pharmacokinetics, preclinical toxicity, clinical comparability, immunogenicity and post marketing risk management

Monitor major regulatory activities in Canada and globally to ensure all opportunities to influence is optimized

Act as an expert in all relevant regulations and guidelines in Canada and other major regulatory jurisdictions

Deliver high caliber training and influencing programs for both regulatory agencies and members of the subsequent entry biologics team with effective metrics to ensure success of these programs

Facilitate the timely dissimilation of health authority position and feedback to all key stakeholders both internal and external as appropriate

Qualifications


PhD/MD with strong background in product development in area of biologics with experience in the development of monoclonal antibodies a definite asset

Knowledge in regulatory science and experience with Health Canada a definite asset, however experience with FDA and EU would be acceptable

Must be politically sensitive, and have ability to strategically shape and influence Key Stakeholders

Excellent communicator and team player

Performs well under pressure

Strong interpersonal and communication skills

Proven leadership skills to facilitate teamwork, innovation and problem-solving

Ability to link projects strategically to business priorities

Demonstrated people skills including negotiation, coaching/mentoring, influencing, and motivating

Other technical skills:

In depth understanding of structural comparability, PK/PD, immunogenicity of complex biologics and its relationship to efficacy and safety

Competency in articulating complex scientific language to regulators, reimbursement agencies, in-house and global J&J collaborators

Ability to write regulatory position papers to influence legislative changes and guideline interpretation

Ability to effectively communicate complex technical information to key stakeholders including regulators, payers, prescribers and patients

Strong publication record in relevant disciplines would be an asset

Strong communication skills (verbal and written)

Strong attention to detail, accuracy and process adherence as well as strong priority management skills

Results and performance driven

Strong analytical and critical thinking skills

Proficiency with Microsoft Office applications, including advanced Excel skills

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-Canada-Ontario-Toronto
Organization: Janssen Inc. (7710)
Travel:Yes, 10% of the time
Job Function: Regulatory Affairs