Regulatory Affairs Associate

4 days ago

Montréal, Canada Medisca Pharmaceutique Inc Full time

**Medisca **is a global corporation with locations throughout North America, Australia, and Europe, that contributes to healthcare by leveraging strong partnerships that deliver customized solutions with an unwavering commitment to quality and innovation. Backed by 30+ years and a strong foundation in pharmaceutical compounding, **Medisca** is a business-to-business company that delivers comprehensive offerings by providing value, consistency, responsiveness, and loyalty. From pharmaceutical compounding products and services, to supply chain solutions, mixing technology manufacturing, analytical testing, IP licensing, to education services and more - **Medisca** delivers extensive solutions that leverages a strong network of partners committed to deeply caring about people. As* Partners in Wellness*, Medisca offers an unfailing devotion to improving lives, across a multitude of needs and across a multitude of people.
The **Regulatory Affairs Associate** is responsible for ensuring compliance of all regulatory requirements in accordance with local state and federal laws of Medisca facilities and business partners. Key objectives are to ensure compliance within all Medisca facilities and markets by reviewing regulatory requirements for product launches, maintenance of regulatory licenses/products as applicable.
**Your key responsibilities**:
Compliance
- Ensure compliance within all Medisca facilities and markets (Canada, USA, Australia and International).
- Keep abreast of state, provincial and federal regulations.
- Create internal regulatory guides for employee training.
- Create and review Standard Operating Procedures (SOPs) to ensure compliance with applicable regulations through change request process.
- Attend seminars, webinars and meetings hosted by regulatory bodies.

Product Launches/Business Initiatives
- Review of regulatory requirements for product launches/business initiatives.
- Conduct regulatory research to support management for Medisca’s operations and business initiatives.
- Support regulatory projects by collaborating with other departments.
- Review product labeling and marketing material within established timelines through an end-to-end process to ensure regulatory, compliance and business needs are met.
- Assess compliance of Research and Development (R&D) formula ingredients and final formulations according to conditions of use.
- Provide risk assessments on suitability and safety of product ingredients.
- Respond to all internal/external inquiries.

Regulatory Licenses/Product Filings
- Update and maintain regulatory licenses and product fillings (as applicable).
- Conduct product filings (regulatory package submissions) as applicable with regulatory agencies.
- Track and maintain regulatory correspondence and submissions.
- Liaise with various internal and external groups to collect necessary documents/information for compliance.

Pharmacovigilance Activities
- Update assigning identifiers using the Medical Dictionary for Regulatory Activities (MedDRA), for adverse drug reaction cases.
- Report and submit adverse drug reactions (ADR) in accordance with Health Canada Regulations.
- Follow up with clients until the ADR evaluation is complete.
- Monitor signal detection findings.
- Prepare annual summary report.

**Travel**:

- Up to two (2) weeks per year to attend conferences

**Skills, knowledge and abilities**:

- Bachelor’s degree in a Science related field
- Minimum two (2) to four (4) years of experience in Quality or Regulatory Affairs
- Knowledge of FDA and Health Canada regulations
- Knowledge in project management
- Knowledge of Microsoft Office suite (Word, Outlook and Excel) required
- Knowledge of Creatio
- Excellent communication skills required; fluent English & French (oral & written). This position requires communication with customers based across Canada and the United States.
- Strong writing skills
- Reliable, accountable, detail-oriented
- Organized, very good judgment and decision making skills

**What’s In It For You **
We invest time and resources into making sure Medisca is as good as the people we hire.
- Work/Life Balance - 37.50 hour workweek with early Fridays all year long
- Your Future is Bright - Opportunities to learn and grow within Medisca
- Help us grow - Employee Referral Program
- Flexible work environment - Hybrid work schedule
- Central location - Free parking/accessible by public transportation; a commercial center is within walking distance for lunch or groceries.
- We like to have fun - company events throughout the year

We are an equal opportunity employer.

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