Regulatory Affairs Associate

2 weeks ago

Toronto, Canada Johnson & Johnson Full time

**Job Function**: Regulatory Affairs Group **Job Sub Function**: Regulatory Affairs **Job Category**: Professional **All Job Posting Locations**: Toronto, Ontario, Canada We are searching for the best talent for our Regulatory Affairs Associate position, located in Toronto, Ontario, Canada, under the flexible working model (at least 3 days in office). **About Innovative Medicine**: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. **You will be responsible to**: - Assist in the preparation and compilation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), Safety Supplements, and ad hoc reports to Health Canada and maintain the life cycle of currently marketed products - Assist in the preparation and review of responses to Health Canada queries (e.g. Clarifax, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]) in a timely manner - Participate in interactions and assist in negotiations with Health Canada throughout the submission review cycle to ensure prompt regulatory approval and optimal labelling - Work with global regulatory teams and the Global Regulatory Affairs (GRA) function/teams to facilitate regulatory activities - Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and stretch goals/deadlines - Support the resolution of emerging issues (e.g. new safety or quality finding) and the associated risk communications to collaborators - Provide regulatory guidance to internal business partners on messaging, promotional material review and PAAB responses - Monitor the regulatory environment, interpret changes, analyze gaps and support the conduct of impact assessment, and participate in implementation into systems/processes - Actively contribute to improving critical departmental processes and to initiatives to enhance the internal work environment **Qualifications**: **Required**: - A minimum of a BSc degree in Biological or related sciences is required - 1-3 years Regulatory Affairs pharmaceutical or related experience, which can include Regulatory Affairs certification - Basic knowledge of the drug development process - Knowledge of Canadian drug laws, regulations, guidelines and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions - Ability to interpret and understand Regulations in the context of the scientific and commercial environment - Good scientific writing skills - Ability to interpret and summarize clinical data - Problem solving and analytical skills - Project management skills and ability to manage multiple priorities - Good communication (oral and written) and strong interpersonal skills - Negotiation and influencing skills - Experience working within teams **Preferred**: - Experience in the oncology or immunology therapeutic area - Experience in preparing therapeutic/labeling submissions - Ability to interpret basic biostatistics **Other**: - Minimal travel required

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