Ontario Association of Medical Laboratories jobs

The Regulatory Affairs Associate is responsible for planning, coordinating, compiling, submitting, obtaining approval, maintaining drug product registrations for Canada and the U.S. and assisting global drug product registrations.

Type:

12-month Contract with an opportunity to convert to full-time based on performance.

Location:

Mississauga, Ontario, Canada

Key Responsibilities:

Your responsibilities encompass a wide range of tasks, all aimed at ensuring the smooth flow of regulatory processes and the successful approval of drug products. Let’s dive into your key areas of focus:

• Plan, coordinate, compile and file drug product submissions for Canada and the U.S. for a variety of dosage forms in eCTD format (e.g. DINs, ANDS, NDS, ANDA, NDAs, S/NDSs, CTAs, NCs, provincial formulary submissions etc.) for the successful registration of drug product for domestic and international markets, with limited supervision.
• Review and approve various product labelling components and marketing materials.
• Prepare submissions in eCTD format, which involves a complete 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.
• Plan, coordinate, compile and file post-approval submissions for FDA (CBE supplement, PAS) and TPD (Notifiable Change, Supplement).
• Review Change Controls and determine filing requirements.
• Liaise with Health Canada and Provincial Formularies on all aspects of the drug submission, follow up for review status and project updates.
• Work on more complex projects which involve identifying and resolving issues on time.
• In consultation with the Manager, provide regulatory guidance and expertise to Sales & Marketing, QC/QA, and Operations departments of Ryvis Pharma.
• Assist in preparing and compiling FDA and TPD pre-approval and GMP inspections.
• Maintain current awareness of regulatory guidelines (Health Canada, FDA, ICH, European Medicines Agency – EMeA, Therapeutic Goods Administration –TGA Australia, etc.).
• Other duties as required by the Manager.

Knowledge, Skills and Abilities:

• Thorough understanding of regulations and guidance published by Health Canada.
• GMP & DEL requirements in Canada.
• Understanding of Pharmaceutical development and manufacturing processes; analytical, labelling clinical and non-clinical knowledge.
• Regulatory submission formats and filing categories.
• Expertise in chemistry and manufacturing, labelling and format requirements for drug product registration for Therapeutic Products Directorate (CTA, ANDS, S/ANDS, NDS, DIN) and US FDA (ANDA, NDA, DMF, IND).
• Knowledge of the use of eCTD Software for preparing and filing submissions is preferred.
• Knowledge of GMP requirements and QA/QC procedures.
• Excellent interpersonal, written and verbal communication skills.
• Proven ability to anticipate challenges and negotiate through them to achieve the desired outcome
• Ability to plan, coordinate and work effectively in a team-oriented environment.
• Superior computer software skills (Microsoft Word, Excel, Access, PowerPoint, Adobe Acrobat, Document Management Systems).
• Strong organizational ability, management of multiple priorities, and proven ability to meet strict and established timelines.
• Multi-tasking various tasks and adhering to strict timelines.

Background and Experience:

• Minimum B. Sc. in a Chemistry, Pharmacy or Life Science discipline combined with at least five (5) to seven (7) years of hands-on Regulatory Affairs experience in filing and managing Canadian and USA submissions, including electronic submissions in eCTD formats.

Problem-Solving:

Good problem-solving abilities are required to prepare written responses to deficiency letters from regulatory agencies and obtain approval of changes to approved drug products.

Working Conditions:

• Multidisciplinary office.
• Extensive use of computer.
• Varied work schedule to meet deadlines, as required.

Schedule:

Regular 5 days per week; 7.5 hours per day

What We Offer:

• Competitive wages
• Bonus program
• Dynamic, close-knit team environment
• Company Events
• Casual dress
• On-site parking

This position is open to applicants legally authorized to work in Canada.

We thank all applicants, but only those selected for an interview will be contacted. No phone calls, please.

Ryvis Pharma is an equal-opportunity employer. We welcome applications from women, aboriginal people, people with disabilities and members of visible minorities. Accommodations in relation to the job selection process are available upon request.

NOTE:

All employment is conditional upon completing and obtaining a satisfactory background check which may include educational, employment, references and criminal records (for which a pardon has not been granted) checks.

AGENCY NOTICE:

Ryvis Pharma does not accept unsolicited resumes from recruiters or employment agencies. Without a signed Services Agreement with an agency/recruiter, Ryvis Pharma will not consider any referrals or agree to payment of referral or recruitment fees. In the event a recruiter or an agency submits a resume or candidate without a previously signed agreement, Ryvis Pharma explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.