Regulatory Affairs - Supervisor

Septodont North America; Cambridge; On-site; CAD 85,000 - 110,000; Full time

Job summary

A leading pharmaceutical company located in Cambridge is seeking a Regulatory Affairs Supervisor to oversee regulatory activities and ensure compliance with guidelines for product registrations in Canada, the US, and internationally. The role involves supervising direct reports, coordinating departmental workload, and interfacing with regulatory bodies. Ideal candidates will have 5+ years of regulatory experience and a Science degree.

Benefits

Excellent compensation/benefits package

Bonus and reward programs

Discounted gym memberships

Programs supporting work-life balance

Employee recognition program

Qualifications

• Minimum of 5 years’ of related experience in a regulated industry.
• Minimum 3 years of leadership experience in a direct regulatory capacity.
• Understanding of eCTD/CTD software is an asset.

Responsibilities

• Supervises the performance of all direct reports at the Cambridge facility.
• Coordinates department workload and supports the manager.
• Ensures documentation packages are in compliance with regulatory requirements.

Skills

Regulatory compliance

Analytical skills

Leadership

Communication skills

Education

Post-Secondary Degree in a Science related field

Job description

Regulatory Affairs - Supervisor

Job Summary

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 to ensure that assignments are completed in a timely and efficient manner.
• 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 such as ANDA/NDA or NDS.
• Routinely interacts with government regulatory bodies such as FDA, Health Canada or foreign governments related to filing product submissions and updates, and follows up in a timely manner to negotiate timely approvals.
• Ensures documentation packages are in compliance with regulatory requirements including giving support to all eCTD/CTD construction.
• 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.
• Supervises the International marketing efforts by supporting Associates in the preparation of documents and materials, to suit individual country registrations, including support to ‘contract’ clients and private label customers.
• Conducts other related regulatory affairs activities consistent with the role of a Regulatory Affairs Associate, such as: Obtains, prepares and reviews documentation required for related filings.
• Provides supports to the International marketing efforts by preparing documents and materials, to suit individual country registrations, including support to ‘contract’ clients and private label customers.
• Acts as backup to RA manager when designated.

Qualifications

• Post-Secondary Degree in a Science related field.
• Minimum of 5 years’ of related experience in a regulated industry such as pharmaceutical or medical devices, including 3 years experience in a direct regulatory capacity with combined experience creating/filed eCTD/CTD files for US, Canada or International markets.
• Minimum 3-year leadership experience in a direct regulatory capacity.
• Full understanding of document management systems or databases, clinical trial execution/support or skilled in the use of the internet for monitoring contemporary scientific literature.
• Understanding of eCTD/CTD software is an asset.
• Knowledge of Canadian Food and Drug Act and Regulations and Medical Device Regulations as well as Health Canada policies and guidelines.
• Experienced success with Health Canada submission experience (NDS, SND’s, NC, DINA, CTA, Medical Device submissions (Class II-III).
• Strong technical knowledge of pharmaceutical manufacturing, quality assurance, GMP, ICH Guidelines.
• Proven analytical and problem-solving skills with the ability to make recommendations.
• Demonstrated organizational skills with the ability to manage multiple priorities with no direction.
• Effective communication skills both verbal and written.
• Ability to supervise/execute highly complex or specialized projects.
• Certification/designation within the RA field would be an asset.

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.

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.