Senior Associate, Regulatory Affairs 18-Month Fixed Employee Contract at Johnson & Johnson

Toronto, Ontario, Canada

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

A minimum B.Sc. in Biological or related sciences. MSc/PhD preferred
Minimum 4 years (with B.Sc.) or 2 years (with MSc/PhD) of pharmaceutical or medical device Regulatory Affairs or related experience, which can include Regulatory Affairs certification
Knowledge of the drug development process
Knowledge of Canadian drug laws, regulations, guidelines and policies
Knowledge of the Health Authority organizational structure and processes for the review and approval of drug submissions
Experience preparing therapeutic/labelling

Responsibilities

Develop and implement regulatory strategic plans for product registration and lifecycle management
Manage the preparation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and ad hoc reports to Health Canada, and maintain the life cycle of currently marketed products (focus on clinical/therapeutic claims, not Chemistry, Manufacturing and Controls)
Manage the development 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
Lead in partnership with Director, Regulatory Affairs interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval and optimal labelling
Work with global cross-functional 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
Develop effective working relationships with business partners and the authorities to support regulatory strategies
Address key emerging issues (e.g. new safety or quality finding) and the associated risk communications
Provide regulatory guidance to internal partners on messaging, promotional material review, and PAAB responses
Monitor the regulatory environment, interpret changes, analyze gaps and conduct impact assessment, and participate/lead implementation into systems/processes
Participate in the improvement of departmental processes and initiatives to enhance the internal work environment

Skills

Regulatory Affairs

New Drug Submissions

Supplemental New Drug Submissions

Health Canada

Regulatory Strategy

Drug Registration

Lifecycle Management

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

Land your dream remote job 3x faster with AI

Try Jobo Free