Specialist 2 - Regulatory Affairs

Job Name: Specialist 2 - Regulatory Affairs Job Location: TORONTO / ONTARIO / M3C 1L9 / CANADA Duration : 06 Months Responsibilities

• Regulatory submission support under the direction of a J&J IM Regulatory team member
• Coordination of the preparation and maintenance of regulatory submissions and filings
• Assess, prepare and compile regulatory submissions (e.g. safety labeling changes) and ad hoc reports to Health Canada and maintain the life cycle of currently marketed products.
• Assist in the preparation and submission of larger submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs).
• 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.
• Engage with other J&J functions and global regulatory teams to facilitate regulatory activities.
• Apply appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements.
• Execute assigned regulatory activities to support compliance requirements and product labeling.
• Complete regulatory activities as assigned within required timelines to meet company and Health Canada requirements.

Personnel Qualifications: Provider’s personnel providing the Services shall at least meet the following qualifications:

• A minimum B.Sc. in Biological or related sciences.
• A minimum of 1 year of Regulatory Affairs pharmaceutical or related experience is required, preferably in Canada

Required Regulatory Associate Core/Technical competency requirements:

• Basic knowledge of the drug development process is required.
• 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 is required.
• Experience preparing and obtaining approval of therapeutic/labeling submissions
• Experience in eCTD submissions and knowledge of Health Canada eCTD regulations and requirements in specific
• Experience with managing the operational aspect of Canadian regulatory submissions (all types; NDS, SNDS, etc)
• Demonstrated project or submission management capabilitie
• Demonstrated effective interpersonal, teamwork, and communication skills
• Ability to use Regulatory Information systems
• Ability to work in a matrix environment
• Good problem solving and analytical skills
• Therapeutic area and product knowledge is preferred

Ability to exercise solid judgment and communicate effectively with varied levels of the organization required About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit US Tech Solutions is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Recruiter Details: Name: I.Prudvi kumar Email: prudvi.k@ustechsolutionsinc.com Internal Id: 25-31499