![Cerapie Pharma Inc.](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs Specialist
2 weeks ago
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**:
- Strong working knowledge of current regulatory guidelines for FDA and/or TPD.
- Experience with eCTD submissions and knowledge of GMP and QA/QC procedures is preferred.
- Knowledge of the use of eCTD Software for preparing and filing submissions is preferred.
- Strong organizational ability to maintain a complex and high volume of technical information up to date.
- Proficiency with applicable computer software - Microsoft Office including Word, Excel and PowerPoint and Adobe Acrobat and Document Management Systems.
- Excellent interpersonal, written and verbal communication skills.
- Ability to plan, coordinate and work effectively in a team-oriented environment.
**Background and Experience**:
- Minimum B. Sc. in a Chemistry, Pharmacy or Life Science discipline combined with at least three (3) to five (5) years of relevant experience within a Canadian, USA or international Regulatory Affairs pharmaceutical environment.
- 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
**Salary**: $3,500.00-$4,500.00 per month
**Benefits**:
- Extended health care
- On-site parking
- Paid time off
Flexible Language Requirement:
- English not required
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 (preferred)
**Experience**:
- pharmaceutical regulatory: 2 years (required)
Work Location: In person
Expected start date: 2023-05-01
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