Regulatory Affairs Specialist

The **Regulatory Affairs Specialist** is responsible for compiling, submitting, and maintaining drug product registrations for the US and Canada and assisting with global drug product registrations.

**Principal Duties and Responsibilities**:

- Prepare and/or review submissions to Health Canada and FDA for a variety of dosage forms (solid oral, liquids, topical semisolids and injectables) in eCTD format (e.g. DMFs, ANDS, NDS, ANDA, NDAs, S/NDSs, DINs, CTAs, NCs, INDs, provincial formulary submissions etc.) for the successful registration of drug products for domestic and international markets.
- Prepare submissions in eCTD format which involves acomplete understanding of the use of Adobe Acrobat to create bookmarks and links.
- Prepare written responses to deficiency letters from regulatory agencies in the stated time frame.
- Prepare and file post-approval submissions for FDA (CBE supplement, PAS) and TPD (Notifiable Change, Supplement).
- Maintain approved product monographs to comply with CRP-PMs.
- Maintained approved drug products for FDA (Annual Report) and TPD (Annual Drug Notification).
- Review and approve various product labelling components and marketing materials.
- Review internal documentation (master batch records, specifications, labelling, product monographs) for adherence to regulatory guidelines.
- Assist in global drug product registrations.
- Maintain current awareness of regulatory guidelines (Health Canada, FDA, ICH, European Medicines Agency - EMEA, etc.).
- Other duties as required.

**Knowledge, Skills and Abilities**:

- Must have strong technical knowledge of CMC requirements and is able to critically analyze scientific data
- Strong interpersonal skills and ability to foster strong working relationships with key stakeholders (internally and externally) and representatives from Health Canada
- Strong working knowledge of Canadian _Food and Drugs Act _and _Food and Drug Regulations_, GMPs, ICH Guidelines and Health Canada Policies and Guidelines
- Knowledge of the _Medical Devices Regulations _is an asset
- Ability to prioritize workload to ensure all deadlines are met
- Must have experience with publishing eCTD submissions.
- Ability to work independently with mínimal supervision
- Excellent organization, written and oral communication skills
- Ability to effectively manage multiple projects in a fast-pace, 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

**Background and Experience**:

- Minimum B. Sc. in a Chemistry, Pharmacy or Life Science graduate.
- Graduate Certificate in Pharmaceutical Regulatory Affairs
- Must have a minimum of three years of experience in filing regulatory submissions with Health Canada.
- Good problem-solving abilities are required to ensure the successful filing of regulatory submissions

**Working Conditions**:

- Multidisciplinary office and manufacturing environment
- Extensive use of computer
- Varied work schedule to meet deadlines, as required
- **This position is open to applicants legally authorized to work in Canada.**_

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

Pay: From $4,000.00 per month

**Benefits**:

- Extended health care
- On-site parking
- Paid time off

Schedule:

- 8 hour shift
- Monday to Friday
- Morning shift

Ability to commute/relocate:

- Mississauga, ON: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (required)

**Experience**:

- pharmaceutical regulatory: 2 years (required)
- eCTD Files registeration with Health Canada: 2 years (preferred)

Work Location: Hybrid remote in Mississauga, ON