Compliance and Regulatory Specialist

3 weeks ago

Toronto, Canada Choice One Medical Full time

Compliance and Regulatory Specialist (International Registrations)

Job Overview:
As a Compliance and Regulatory Specialist focusing on International Registrations, you will play a critical role in ensuring that our organization adheres to all relevant regulations and standards in various jurisdictions for product registrations. You will work closely with cross-functional teams to coordinate and manage the process of obtaining and maintaining international registrations for our products. Your expertise will be instrumental in navigating complex regulatory landscapes and ensuring compliance with relevant laws and guidelines.

**Responsibilities**:

- International Regulatory Compliance:

- Stay abreast of relevant regulations, guidelines, and standards governing product registrations in target international markets.
- Interpret regulatory requirements and assess their impact on product registrations and market access strategies.
- Develop and implement compliance strategies to ensure adherence to regulatory requirements.
- Maintaining and updating ISO documents, records, and systems to ensure compliance and continuous improvement
- Product Registration Management:

- Lead the process of obtaining and maintaining product registrations in international markets.
- Coordinate with internal stakeholders and external partners to gather necessary documentation and information for submissions.
- Track registration timelines, milestones, and deadlines to ensure timely approvals and renewals.
- Regulatory Intelligence:

- Conduct regulatory intelligence activities to identify changes in regulations, guidelines, and industry trends that may impact product registrations.
- Evaluate the potential impact of regulatory changes on existing registrations and develop strategies for compliance.
- Cross-functional Collaboration:

- Collaborate with internal teams, including R&D, Quality Assurance, Legal, and Supply Chain, to ensure regulatory requirements are incorporated into product development and manufacturing processes.
- Provide regulatory guidance and support to cross-functional teams throughout the product lifecycle.
- Documentation and Recordkeeping:

- Maintain accurate and up-to-date records of all regulatory submissions, approvals, and correspondence with regulatory authorities.
- Ensure compliance with document control procedures and regulatory requirements for recordkeeping.
- Audit and Inspection Support:

- Support regulatory audits and inspections by preparing documentation, coordinating responses to inquiries, and addressing findings as needed.
- Assist in the implementation of corrective and preventive actions to address audit observations and ensure ongoing compliance.

Qualifications:

- Bachelor's degree in Regulatory Affairs, Life Sciences, Chemistry, Engineering, or related field. Advanced degree preferred.
- In-depth knowledge of international regulations and standards governing product registrations, such as FDA, EMA, Health Canada, TGA, and other regulatory agencies.
- Experience preparing and submitting regulatory filings, including technical documentation, registration dossiers, and product notifications.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
- Detail-oriented with strong organizational skills and the ability to manage multiple projects simultaneously.
- Regulatory affairs certifications (e.g., RAC) are desirable but not required.

Pay: $63,000.00-$119,400.00 per year

**Benefits**:

- Company events
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Vision care
- Wellness program

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (preferred)

Work Location: In person

Application deadline: 2024-04-19
Expected start date: 2024-05-01

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