Regulatory Affairs - Supervisor

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

Job summary

A leading pharmaceutical company in Cambridge is seeking a Regulatory Affairs Supervisor to oversee regulatory activities related to product registrations. The ideal candidate will have a post-secondary degree in a science-related field, 3+ years in a regulated industry, and 1+ years in a leadership role. This role offers excellent benefits, opportunities for professional development, and a focus on work/life balance.

Benefits

Excellent compensation/benefits package

Bonus and reward programs

Discounted gym memberships

Programs supporting work life balance

Employee recognition program

Professional and personal development programs

Social events and spirit days

Qualifications

• 3+ years of experience in a regulated industry such as pharmaceutical or medical devices.
• 1+ year of leadership experience in a direct regulatory capacity.
• Experience creating and filing eCTD/CTD files for US, Canada or International markets.

Responsibilities

• Supervise performance and development of direct reports.
• Participate in hiring processes for departmental staff.
• Allocate departmental resources and monitor job performance.
• Lead and manage projects for regulatory submission approvals.
• Ensure documentation compliance with regulatory requirements.

Skills

Regulatory compliance

Leadership

Project management

Communication

Education

Post-Secondary Degree in a Science related field

Job description

Company Overview

Novocol Pharma is a growing contract development and manufacturing organization (CDMO), specialized in sterile injectable cartridges and combination product manufacturing. We strive for excellence and customer-centricity to deliver value to global pharmaceutical clients through contract services for drug development and commercial manufacturing.

Our employees are our number one asset! We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.

We are a proud member of the Septodont group of companies. Septodont is a pharmaceutical and medical device company with a global leadership position in dental pain management.

Job Description

The Regulatory Affairs Supervisor is accountable to the Regulatory Affairs Manager for all areas related to the regulatory activities of Septodont with respect to the pharmaceutical product registrations, both current, and future, in the Canadian, US and International marketplace.

Responsibilities

• Supervises the performance and development of all direct reports at the Cambridge facility.
• Participates in cooperation with the Manager in the hiring process for departmental staff.
• Allocates departmental resources according to the requirements of the work schedule and monitors their job performance.
• Assist in the coordination of department workload and other Associates in support of the manager.
• Assist in the training of the RA Associates as required.
• Responsible to participate in review and revision of departmental SOPs and other GMP and company procedures.
• Represents Regulatory concerns and interests on assigned project teams and in inter-departmental meetings.
• Leads and/or manages projects as needed to compile documentation and prepare packages necessary for regulatory submission approvals.
• Routinely interacts with government regulatory bodies such as FDA, Health Canada or foreign governments related to filing product submissions and updates.
• Ensures documentation packages are in compliance with regulatory requirements.
• Supervises the process of preparing necessary documents and responsible for thorough review of documents to ensure regulatory compliance.
• Supervises primary regulatory interface for label copy approvals, and specification changes.
• Conducts other related regulatory affairs activities consistent with the role of a Regulatory Affairs Associate.

Requirements

• Post-Secondary Degree in a Science related field.
• Minimum of 3 years’ experience in a regulated industry such as pharmaceutical or medical devices.
• Minimum 1-year leadership experience in a direct regulatory capacity.
• Certification/designation within the RA field would be an asset.
• Experience creating and filing eCTD/CTD files for US, Canada or International markets.

What We Offer

• Excellent compensation/benefits package.
• Bonus and reward programs
• Discounted gym memberships
• Programs supporting work life balance
• Employee recognition program
• Professional and personal development programs
• Social events and spirit days

We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.

In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.

Note: Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site.