Regulatory Affairs Specialist 2 (Pharma Exp Needed)

Internal ID : 25-31499

Duration : 07 months contract

Job Description : Notes :

We would like to follow J&J Flex with the contractor coming to the office around 3 days per week. This allows the contractor to work directly with the client.

The building is closed on Fridays. The three days that the contractor comes to the office between Monday and Thursday can be flexible.

The contractor must be able to work effectively from a remote location, ideally with two screens which is needed for the type of work we do!

Responsibilities :

Job Description - REGULATORY ASSOCIATE (Third-party contract)

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 : .

Experience :

A minimum of 1 year of Regulatory Affairs pharmaceutical or related experience is required, preferably in Canada

Skillsets :

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 capabilities

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

Education :

A minimum B.Sc. in Biological or related sciences

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 www.ustechsolutions.com

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.