Regulatory Affairs Analyst

Regulatory Affairs Analyst

**Category**:Reg Affairs & Safety Pharmacovigilance

**Location**:Mississauga, Ontario, CA

**Regulatory Affairs Analyst (15-month contract)**

**PURPOSE**
- Prepares labelling submissions and manages all aspects of labelling using conventional methods or NNCI's labeling system. Prepares submissions and obtains Health Authority approval for post-approval changes for marketed products and Clinical Trial Submissions for products in development.
- Prepares medical device submissions for new and existing devices, and performs related medical device activities, including maintenance of medical device licenses. Manages assigned projects.

**RELATIONSHIPS**
- REPORTS TO: Director, Regulatory Affairs
- # DIRECT REPORTS: None

**ESSENTIAL FUNCTIONS**
- Labelling Management
- Provides input into the Regulatory Affairs Submissions Plan (RASP) by assessing all Health Canada Regulations, Policies, Guidances & prior correspondence with Health Canada and NNAS, to determine if the RASP will fulfill all the necessary requirements to obtain approval from Health Canada for the post-approval labelling change
- Manages the translation and proof-reading of the Product Monograph and all labelling on behalf of RA
- Manages the preparation of mock-up labelling for submission to Health Canada
- Prepares the post-approval labelling submission and ensures it is filed within NN KPI’s. Assesses labelling deviation from CCDS and manages the Labelling Change Request (LCR) and obtains the required Product Labelling Council (PLC) approval, as required
- Manages the approval of all final product labelling artwork by liaising with NNCI Logistics, NNAS Production Planning (DK), RA Labelling and Graphics (Bangalore) and local RA to meet launch plans
- Coordinates and implements labelling changes by liaising with NNCI Logistics, NNAS Production Planning, RA Labelling and Graphics and local RA as per established timelines
- Ensures all bar coding is current and accurate by liaising with GS1 Canada ensuring product labelling meets GTIN coding standards and future requirements
- Assesses new and revised product labelling and templates to comply with local government approved guidance, standards and Novo Nordisk CVI requirements
- Keeps track of recertification for proof-readers to ensure all are compliant with internal requirements
- Establishes and maintains records of labelling artwork and labelling samples for inspection and archiving purposes
- Post-Approval Changes, Clinical Trials and Medical Device Assessment and Submission Preparation
- Provides input into the Regulatory Affairs Submissions Plan (RASP) by assessing all Health Canada Regulations, Policies, Guidances & prior correspondence with Health Canada and NNAS, to determine if the RASP will fulfill all the necessary requirements to obtain approval from Health Canada
- Prepares and obtains approval for post-approval submissions as per Health Canada requirements and NN Standard Operating Procedures
- Assists in the preparation of submissions for new drug products or product line extensions as directed by Manager, Regulatory Affairs through the collaboration with the Regulatory Affairs (RA) Portfolio Support Teams at Head Office or the services of a 3rd Party to ensure marketplace availability and growth
- Assess documents for Clinical Trial submissions and prepares clinical trial submissions in order to gain Health Canada approval
- Prepares submissions to ensure compliance to Medical Device regulations by assessing and filing the registration documentation to obtain approval, and maintaining the Medical Device license once issued
- Ensures tasks are managed utilizing internal systems (e.g. novoDOCS, RIMS, RA PLANiT, novoGloW, ePUB) according to NN internal procedures
- Pharmacovigilance
- Provides safety information related to product registration as requested by Health Canada (i.e. MHPD) such as PBRER or PSUR, RMP and relevant safety work-up, as directed by RA
- Other
- Performs work assignments (compilation of databases, preparation of CPS documentation, tracking ATI requests, archiving of paper documentation) as assigned by Manager, Regulatory Affairs
- Complies with Novo Nordisk policies, procedures, vision and fundamentals
- Performs other tasks as assigned by management

**PHYSICAL REQUIREMENTS**
- Works in an open-office environment with exposure to multiple demands, deadlines and constant interruptions. Little exposure to hazards while performing the duties of the job. Occasional out of town travel.

**QUALIFICATIONS**
- Education and Certifications:

- University Degree (Life Sciences)
- Regulatory Affairs Post-Graduate Certificate (preferred but not required)
- Bilingualism (French & English)
- Work Experience:

- 3+ years of hands-on experience in regulatory submission preparation
- Knowledge and experience in the pharmaceutical or biological industry an asset
- Knowledge, Skills, and Abilities:

- Good knowledge of Health Canada drug & device Regu