Regulatory Affairs

2 days ago

St Catharines, Canada Biolyse Pharma Full time

**Key Responsibilities**
- Provides input into and/or develops the plan for submissions/activities
- Supports and/or leads the preparation of regulatory submissions/activities (i.e., ANDSs, SANDSs, Annual Notifications, Training, Compliance)
- Ensures regulatory compliance with Health Canada, industry, and Biolyse codes and guidelines in alignment with business needs
- Provides input into the development of submission, training, or compliance strategies. Works with internal stake holders to negotiate with Health Canada to achieve rapid approval of submissions and achieve timely completion of projects
- Liaises with multiple local and global functional groups to ensure Canadian regulatory needs are met
- Co-ordinates with health Canada for Annual License renewals, DIN fees, CPP and GMP certificate requests
- Identifies and responds to issues related to assigned projects

**Qualifications Required**
- B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
- Experience in regulatory affairs
- Good working knowledge of the Canadian Food and Drug Regulations, relevant guidelines and policies
- Agile with the ability to react quickly and provide creative solutions to problems and navigate change
- Able to contribute to the development of regulatory strategies aligned with commercial objectives
- Excellent oral and written communication with the ability to present to small and large groups
- Good negotiation skills
- Accountable to simultaneously manage multiple projects and meet tight timelines
- Excellent attention to detail and accuracy of work
- Acts with integrity and demonstrates a strong quality mindset
- Ability to provide and receive feedback, raise issues, share experiences and lessons learned
- Proactive and seeks to constantly learn and develop. Ensures that skills meet changing business needs
- Collaborative with the ability to work with diverse groups of individuals in a team and to express opinions, including as part of group discussions. Open to diverse ideas, styles and perspectives
- Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook

**Preferred Qualifications**
- Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs

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

**Salary**: $18.00-$20.00 per hour

**Benefits**:

- On-site parking

Schedule:

- 8 hour shift

**Education**:

- Bachelor's Degree (preferred)

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