Regulatory Affairs Specialist

2 months ago


Mississauga, Canada Cerapie Pharma Inc. Full time

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



  • Mississauga, Canada Cardinal Health Full time

    Cardinal Health Canada, with over 1300 employees nationwide, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country. Cardinal Health Canada is currently seeking a Regulatory Affairs Specialist to join the Regulatory Affairs and Quality Assurance team...


  • Mississauga, Canada BD Full time

    **Job Description Summary**: We are** the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...


  • Mississauga, Canada ct bakery Full time

    _We are seeking a dedicated Regulatory Affairs Specialist - _**Food Industry**_ _to join our team. The Regulatory Affairs Manager will play a crucial role in guiding regulation strategies. This position requires strong regulatory knowledge, strategic thinking, and the ability to collaborate effectively across departments and with regulatory...


  • Mississauga, Canada BAXTER Full time

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...


  • Mississauga, Canada Baxter International Inc. Full time

    This is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost...


  • Mississauga, Ontario, Canada BAXTER Full time

    Job DescriptionAt Baxter, we believe that our work improves outcomes for millions of patients. As a Senior Regulatory Affairs Associate, you will play a vital role in the local implementation of regulatory strategies and ensure compliance with Health Canada requirements.About the RoleThis is an exciting opportunity to join our team as a Senior Regulatory...


  • Mississauga, Ontario, Canada BAXTER Full time

    Product Compliance ExpertiseWe are seeking a skilled Regulatory Affairs Specialist to join our team at Baxter, a leading healthcare company dedicated to saving and sustaining lives. This role will play a critical part in ensuring compliance with regulatory requirements for our products in Canada.About the Role:This position involves working under limited...


  • Mississauga, Canada CT BAKERY Full time

    Job Overview* **Duties**: - Develop and implement regulatory strategies for product approvals - Monitor and interpret regulatory requirements and changes - Prepare and submit regulatory filings and documentation - Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle - Conduct regulatory research and...


  • Mississauga, Canada Cliantha Research Ltd. Full time

    **Job Description / Roles and Responsibilities for Job Title**: **1)** Maintain an excellent knowledge of clinical trials/clinical research and a thorough understanding of industry regulatory requirements **2)** Stay current on regulatory updates and issue regular communications bulletins within the organization **4)** Communication with the regulatory...


  • Mississauga, Canada BAXTER Full time

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...


  • Mississauga, Canada Bayer Full time

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Mississauga, Canada GE Healthcare Full time

    **Job Description Summary**: The Regulatory Affairs Intern will be involved in Premarket and Compliance duties. They will work with a team of Regulatory Affairs professionals and provide support to ensure GEHC establishes and implements best practice processes and procedures in premarket support. **Key responsibilities/essential functions include**: - **...


  • Mississauga, Canada Amgen Full time

    Career Category Regulatory **Job Description**: HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is...


  • Mississauga, Canada BD Full time

    **Job Description Summary**: **We are **the makers of possible**: BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...


  • Mississauga, Canada Amgen Full time

    **HOW MIGHT YOU DEFY IMAGINATION?** You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...


  • Mississauga, Canada ct bakery Full time

    The primary focus of the role is to ensure the accuracy of the regulatory information in our databases for ingredients, allergens, formulas and labels; - Issuance of label information documents that comply with the regulations; and regulatory compliance of final product labels including product naming, ingredients, nutrition facts, claims, third party...


  • Mississauga, Canada AstraZeneca Full time

    **About us**: Are you passionate about **science** and experienced within **drug development** and **regulatory affairs**_? _Would you like to combine your **project management skills** with your experience of working cross functionally and globally? At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’...


  • Mississauga, Canada M&M Food Market Full time

    **Description** **Competitive Benefits. Meaningful Extras. Unmatched Value.** - A place where you can take your career in the direction you want to grow and go - Flexible work options and summer hours for eligible employees - Save on gas at stations across Canada, including Chevron, Fas Gas, Ultramar, and Pioneer - Save on M&M Food Market products **The...


  • Mississauga, Canada Mint Pharmaceuticals Inc. Full time

    Job description Canadian-owned and operated, Mint Pharmaceuticals Inc. ("Mint") is a leading manufacturer of high-quality and affordable generic pharmaceutical products. With a focus on consistent supply, innovation and exceptional customer service, Mint aims to deliver the highest value to patients across Canada. Mint has repeatedly been recognized as one...


  • Mississauga, Canada CT Bakery Full time

    Job Overview* **Duties**: - Develop and implement regulatory strategies for product approvals - Monitor and interpret regulatory requirements and changes - Prepare and submit regulatory filings and documentation - Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle - Conduct regulatory research and...