Regulatory Affairs

**Company detail**:
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.

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. 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.

**Responsibilities**:
**PRIMARY RESPONSIBILITIES**:

- Supervises the performance and development of all direct reports at the Cambridge facility. In 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).
- 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. 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.

**Qualifications**:
**BASIC REQUIREMENTS**:

- Post-Seconda