Manager, Regulatory Affairs

1 day ago

Montréal, Canada IntelGenx Corp. Full time

Be accountable for the regulatory compliance within the area of responsibilities.

Provision of regulatory advice to and liaise with key internal groups.

**Responsibilities**:

- Lead and prepare high quality submissions (NDS,CTA, NDA, ANDA) that meet eCTD requirements through execution of regulatory submission strategies for new product registrations or to ensure continual regulatory compliance for product related changes (including CBE-30, etc).
- Work with the research and development group and external partners globally including participation in cross-functional teams with strategic input in the development and review of product strategies and developing solutions to issues to facilitate timely regulatory approvals.
- Build and maintain interactions with Health Authorities and other external stakeholders. As directed, communicate and negotiate effectively with Federal Regulatory Authorities regarding regulatory submissions.
- Request and assist in managing and conducting Health Authority meetings as needed during the drug development and filing processes.
- Provide impact / assessments regarding changes in CMC or clinical drug development, as well as post-approval changes.
- Develop or maintain departmental procedures and processes to ensure compliance with the Food & Drugs Act, Health Canada Regulations, and other applicable industry standards.
- Participate in establishing the quality system within Regulatory Affairs.
- Support implementation of QA systems and generation of Standard Operating Procedures.
- Maintain awareness of current regulatory environment and guidelines that impact the organization
- Perform Regulatory Affairs and other administrative duties as assigned.

**Job Requirements**:
B.Sc. in life science discipline from a Canadian University or equivalent.
- Minimum of 2 years in the regulatory field within the pharmaceutical industry
- Post-graduate Certificate in Regulatory Affairs, preferred.
- Strong knowledge of Canadian and FDA regulations as well as ability to interpret policies and guidelines
- Strong scientific knowledge and knowledge of the drug development process
- Must have strong technical knowledge of pharmaceutical manufacturing, quality assurance, GMP, and ICH guidelines
- Excellent time management and project management skills
- Ability to work independently and self-motivated to achieve results.
- Proven oral and written communication skills in English

**Job Types**: Full-time, Permanent

Additional pay:

- Bonus pay

**Benefits**:

- Casual dress
- Dental care
- Disability insurance
- Extended health care
- Flextime
- Life insurance
- On-site parking
- Work from home

Schedule:

- 8 hour shift

Ability to commute/relocate:

- Montréal, QC: reliably commute or plan to relocate before starting work (required)

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