Regulatory Affairs Associate

5 days ago

Mississauga, Canada Mint Pharmaceuticals Inc. Full time

Job description

Canadian-owned and operated, Mint Pharmaceuticals Inc. ("Mint") is a leading manufacturer of high-quality and affordable generic pharmaceutical products. With a focus on consistent supply, innovation and exceptional customer service, Mint aims to deliver the highest value to patients across Canada. Mint has repeatedly been recognized as one of the leading generic companies in Canada and most reputable pharmaceutical companies in Canada. Since 2014, the company has averted 19 national drug shortages on 13 different drugs through its best-in-class supply chain management. The company was recognized by Deloitte and CIBC as one of Canada's Best Managed Businesses since 2019.

**Position: Regulatory Affairs Associate**

**Primary Functions**:
The Regulatory Affairs Associate will be primarily responsible for the complication and filing of new regulatory submissions for new products with Health Canada in a timely manner. The position involves providing a full range of regulatory support including submission preparation and document authoring.

Duties will include:

- Author, compile, review and publish regulatory submissions in eCTD format for different dosage forms to Health Canada (NDS, ANDS, S/ANDS, X-Ref) in a timely manner
- Prepare, consult, and provide expert guidance on product labelling (including Product Monographs) and coordinate French translation
- Review submission documentation for compliance with Health Canada requirements. Identify weakness for submission and work with stakeholders to provide expert guidance to ensure compliance with Canadian requirements
- Compile and prepare responses to deficiency letters (Notices of Non-Compliance, Notices of Deficiency, Screening Clarification, etc) received from regulatory authorities in a timely manner
- Liaise and assist with negotiations with Health Canada representatives, as needed, to support responses to deficiencies and validate submission strategy planning
- Communicate with internal and external stakeholders obtain documents required to support regulatory submissions, communicate the company’s position and work to eliminate hurdles
- Review documentation and provide regulatory input on development projects to ensure compliance with Canadian requirements
- Communicate and guide external stakeholders with respect to clinical studies to be performed for Mint Pharmaceuticals Inc.
- Monitor and maintain regulatory compliance of the product through post-approval activities and filings
- Remain up to date on applicable regulatory guidelines (Health Canada, FDA, ICH, etc.)
- Develop departmental working guidelines to document standard processes in the department

Additional duties as assigned by Senior Scientific and Regulatory leadership team.

**Skills & Qualifications**:

- Bachelor of Science (or higher) in Biological Sciences, Pharmacology, Toxicology, Chemistry or related Health Sciences
- Graduate Certificate in Pharmaceutical Regulatory Affairs is preferred
- Previous experience filing regulatory submissions with Regulatory Authorities
- Must have strong technical knowledge of CMC requirements and is able to critically analyze and draw conclusion from scientific data
- Strong interpersonal skills and ability to foster strong independent working relationships with key stakeholders (internally and externally) and representatives from Health Canada
- Expert knowledge of Canadian _Food and Drugs Act _and _Food and Drug_ _Regulations_, GMPs, ICH Guidelines and Health Canada Policies & Guidelines
- Ability to prioritize workload and effectively manage multiple projects in a fast-paced, results oriented environment to ensure all deadlines are met
- Excellent organization, written and oral communication skills
- Proven ability to effectively manage multiple projects in a fast-paced, results oriented environment
- Strong commitment to quality, accuracy and detail
- Ability to work well under pressure in a team-based environment
- Strong problem solving / analytical ability and issue-resolution skills

**Benefits**:

- Company events
- Dental care
- Extended health care
- On-site parking
- Paid time off
- Vision care
- Work from home

Schedule:

- Monday to Friday

Work Location: Hybrid remote in Mississauga, ON L5T 2M3

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