Regulatory Compliance Manager, Regulatory Developments

Scientific - Regulatory Affairs
Regulatory Affairs - Supervisor
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. With over 40 years in operation our team of 600 employees and modern facilities located in Cambridge Ontario provide a personalized and responsive experience for our customers. We are focused on serving our strategic partners and patients with quality integrity and value.
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.
Septodont is a pharmaceutical and medical device company with a global leadership position in dental pain management. The group counts over 2000 employees worldwide and has remained a 100% family owned company for over 90 years. Our Cambridge facility serves as a significant manufacturing site within the Septodont group with high volume dental anesthetic production for a global customer base.
We have an opportunity for a 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. Further the position supports the regulatory needs for medical device requirements of the Canadian market including direct involvement with Septodont (France) as needed. This position seeks to ensure that all corporate and governmental regulations and procedures are upheld.
Supervises the performance and development of all direct reports at the Cambridge conjunction with Human Resources conducts employee relations activities (e.g. completion of employee performance reviews carrying our performance improvement initiatives and guiding employee improvement action plans recommend and administer disciplinary action and guide conflict resolution by investigating employee complaints and initiating suitable resolution).
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 training of the RA Associates as required.
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. Communicates with other departmental managers and relevant personnel in preparation of studies documents or any tasks related to complying with regulatory requirements and filings.
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. This includes routine annual updates establishment license updates and specific activities needed for International registrations or ANDA or NDA preparation.
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.

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 SNDs NC DINA CTA Medical Device submissions (Class II-III).
Strong technical knowledge of pharmaceutical manufacturing quality assurance GMP ICH Guidelines.
Ability to supervise/execute highly complex or specialized projects.
Certification/designation within the RA field would be an asset.

Bonus and reward programs
Professional and personal development programs
Social events and spirit days

We are committed to diversity and inclusion and thank all applicants in advance; 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.
Recruitment Fraud please be aware of recruitment fraud. 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 addition we will only use official corporate e-mail addresses ( or ) to communicate with applicants. Contract type
Permanent