Regulatory Affairs Supervisor — Lead Global Submissions (US/Canada)

Septodont; Cambridge; On-site; CAD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a Regulatory Affairs Supervisor in Cambridge to manage regulatory activities for pharmaceutical product registrations. The role includes supervising staff, interacting with regulatory bodies like FDA, and ensuring compliance with regulations. Candidates should have 5+ years in a regulated industry with significant regulatory experience and strong analytical skills. Excellent compensation and benefits package offered.

Benefits

Excellent compensation / benefits package

Bonus and reward programs

Discounted gym memberships

Work-life balance programs

Employee recognition program

Professional and personal development programs

Social events and spirit days

Qualifications

• A minimum of 5 years of related experience in a regulated industry.
• At least 3 years experience in a direct regulatory capacity.
• Proven analytical and problem-solving skills.

Responsibilities

• Supervises the performance and development of direct reports.
• Leads projects for regulatory submission approvals.
• Interacts with government regulatory bodies.

Skills

Proofreading

FDA Regulations

Manufacturing & Controls

Biotechnology

Clinical Trials

Research & Development

GLP

cGMP

Product Development

Chemistry

Writing Skills

Education

Post-Secondary Degree in a Science related field

Job description

A leading pharmaceutical company is seeking a Regulatory Affairs Supervisor in Cambridge to manage regulatory activities for pharmaceutical product registrations. The role includes supervising staff, interacting with regulatory bodies like FDA, and ensuring compliance with regulations. Candidates should have 5+ years in a regulated industry with significant regulatory experience and strong analytical skills. Excellent compensation and benefits package offered.