Cmc Document Specialist Formulation Development

2 weeks ago

Mississauga, Canada Biolab Pharma Ltd. Full time

**Title: CMC Document Specialist Formulation Development**

**Reports to: Manager Formulation Development**

The formulation development CMC Documentation Specialist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. These activities will be achieved by supporting the documentation activities for regulatory submissions for pharmaceutical, veterinary and NHP products as part of Biolab’s CMC Strategies.

The CMC Regulatory Specialist has the responsibility to support new product approvals, existing product renewals, and post-approval changes for global registrations (Health Canada, ANVISA, FDA, others) in a timely manner while complying with departmental SOP's and guidelines set out by the regulatory agencies and ICH (International Conference on Harmonisation). This will be achieved by working very closely with the analytical development and R&D QA teams.

This role requires effective collaboration across technical functions to deliver on timelines for submissions.

**Key job responsibilities and duties**:

- Responsible and accountable for the creation and assembly of module 2 and module 3 documents required to support the submission of new products as per departmental SOP’s and ICH guidelines to Health Canada, FDA, ANVISA and other regulatory agencies. This should be done in consultation with RD&I Scientists, Managers and upper management.
- Assist with and support dossier creation and system compliance for regulatory submissions.
- Support the logístical process for regulatory submissions within Biolab sites.
- Collaborate with creation and assembly of regulatory documents, and team efforts to complete all relevant CMC documentation.
- Assist in the facilitation of authoring, review, verification, and submission-ready compliance for the finalization of filings.
- Participate in initiatives involved with regulatory filings.
- Participation in various cross-functional project teams, interactions with technical, scientific and regulatory staff at different Biolab sites and other key partners both internal and external to the company are necessary.

**Education and experience requirements**:

- Canadian equivalent to Bachelor of Science degree, preferably in Pharmacy, Chemistry or Pharmaceutical Chemistry. Advanced degree is an asset.
- More than three years of relevant hands on pharmaceutical experience in the creation and assembly of regulatory submission CMC documentation as per ICH, FDA and Health Canada guidelines.
- Demonstrated good understanding and proficiency in writing module 2 and module 3 documents following CTD and eCTD guidelines.
- Proven record of accomplishment for participating in the documentation activities for CMC regulatory filing.
- Demonstrated proficiency level in Microsoft word and Adobe Acrobat Pro DC
- Demonstrated ability to work independently or as a part of a team.
- Highly motivated and have the skills to handle multiple projects and prioritize the work.
- Excellent communication skills (oral and written) and interpersonal skills are required

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

**Salary**: $31,413.88-$56,164.17 per year

**Benefits**:

- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flextime
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Vision care

Flexible Language Requirement:

- French not required

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday
- No weekends

Supplemental pay types:

- Bonus pay

Ability to commute/relocate:

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

**Education**:

- Bachelor's Degree (required)

Work Location: One location

  • Associate Scientist Formulation Development

    1 week ago

    Mississauga, Canada Biolab Pharma Full time

    **Key job responsibilities and duties**: Responsible and accountable for designing, planning and executing all aspects of assigned projects through scientific rationale using Quality by Design principles to develop new products per departmental SOP’s and ICH guidelines. This should be done in consultation with senior peers: Formulation Scientists, Manager...

  • Regulatory Affairs Project Manager Cmc

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...

  • Jr. R&d Chemist

    4 weeks ago

    Mississauga, Canada International Custom Pak Inc Full time

    International Custom Pak is a Canadian contract and private label manufacturer of customized health & beauty and personal care products. We are growing our team and looking for a creative, curious-minded, and self-motivated junior chemist who can assist with the research & development of cosmetic-grade formulations. The incumbent will be responsible for...

  • Pharmaceutical Formulation Scientist

    5 days ago

    Mississauga, Canada Covar Pharmaceuticals Full time

    Covar Pharmaceuticals provides formulation development contract services for pharmaceutical products at all development stages with a focus on new chemical entities and novel technologies. We offer consulting, formulation development, analytical development and clinical supply manufacturing to Canadian and international clients from our facility in...

  • Production Print Specialist

    1 month ago

    Mississauga, Canada Kyocera Document Solutions Canada Full time

    **Job Title**:Production Print Specialist **Department**:Product Marketing **Location**:Mississauga, Ontario **Reports to**:President **About the Company** When you join Kyocera Document Solutions Canada, Ltd., you are joining an organization that is deeply rooted in the Philosophy of “doing what is right as a human being”. Through this Philosophy,...

  • Machining Documentation Specialist

    6 days ago

    Mississauga, Canada Avion Technologies Inc. Full time

    Job Title**:Machining Documentation Specialist** As a Machining Documentation Specialist, you will play a pivotal role in documenting detailed instructions for the machining process. **Skilled in basic photography, understanding drawings, you will capture images of parts in various stages of production. Your work duties will extend to the development of...

  • Research and Development Specialist

    1 month ago

    Mississauga, Canada Sofina Foods Inc Full time

    Join Us! Our team is looking for a Research and Development Specialist for our Mississauga facility. Join our family of diverse, talented, and dedicated people and become part of an industry-leading company as we strive to be the most successful food company in the world. **Title**: Research and Development Specialist **Location**: Mississauga **Job...

  • Channel Marketing Specialist

    1 day ago

    Mississauga, Canada KYOCERA Document Solutions Canada, Ltd. Full time

    Job Title: Channel Marketing Specialist Location: Mississauga, Ontario Reports to: Director, Marketing About the Company When you join Kyocera Document Solutions Canada, Ltd., you are joining an organization that is deeply rooted in the Philosophy of “doing what is right as a human being”. Thr

  • Real Estate Specialist

    4 weeks ago

    Mississauga, Canada MOBIA Technology Innovations Full time

    Montreal, Quebec MOBIA Technology Innovations is a Systems Integration company with multiple business unit areas: Broadband Wireless Services, Managed Services, Infrastructure Solutions, Cybersecurity, and Application and Data Services. Working with Telecommunication Service Providers, Government, Healthcare, and Enterprises across Canada, MOBIA has...

  • Lease Documentation Specialist

    4 weeks ago

    Mississauga, Canada Morguard Full time

    PURPOSE The  Lease Documentation Specialist, Retail  is accountable to the Manager, Retail  Lease Documentation  for supporting the activities aimed at protection of interests of the company and its clients against risks associated with lease documentation by participating in the process of preparation, negotiation, revision and finalization of...

  • Chemist; R&d Formulation Development

    6 days ago

    Mississauga, Canada Aurora Marine Industries inc Full time

    _**Position**_ **Chemist; R&D Formulation Development** - **Post Date**_ January 28, 2020 - **Location**_ 7015 Ordan Dr., Mississauga, ON, Canada - **Job Type**_ Full time - **Description**_ Job: Full Time 9:00 to 5:00 M to F. Location: Dixie Rd. Courtney Park Dr. Mississauga ON area: 7015 Ordan Dr. #11, Mississauga ON L5T 1Y2 - _For Fastest Response,...

  • Program Development Specialist

    6 days ago

    Mississauga, Canada Skilled Trades Ontario Métiers spécialisés Ontario Full time

    Position Title: Program Development SpecialistPosition Type: Fixed-Term Contract Position Duration: Eighteen (18) Months Location: Mississauga, ON Job Band: 10 Salary Range: $38.46 - $50.23 / hour Hours of work: 36.25 hr/week Reporting to: Supervisor, Standards This posting is applicable to: Internal & External ApplicantsSkilled Trades Ontario is a Crown...

  • Program Development Specialist

    1 week ago

    Mississauga, Canada Skilled Trades Ontario Métiers spécialisés Ontario Full time

    Position Title: Program Development Specialist Position Type: Fixed-Term Contract Position Duration: Eighteen (18) Months Location: Mississauga, ON Job Band: 10 Salary Range: $38.46 - $50.23 / hour Hours of work: 36.25 hr/week Reporting to: Supervisor, Standards This posting is applicable to: Internal & External Applicants Skilled Trades Ontario is a Crown...

  • Program Development Specialist

    1 week ago

    Mississauga, Canada Skilled Trades Ontario Métiers spécialisés Ontario Full time

    Position Title: Program Development Specialist Position Type: Fixed-Term Contract Position Duration: Eighteen (18) Months Location: Mississauga, ON Job Band: 10 Salary Range: $38.46 - $50.23 / hour Hours of work: 36.25 hr/week Reporting to: Supervisor, Standards This posting is applicable to: Internal & External Applicants Skilled Trades Ontario is a Crown...

  • Program Development Specialist

    1 week ago

    Mississauga, Canada Skilled Trades Ontario Métiers spécialisés Ontario Full time

    Position Title: Program Development Specialist Position Type: Fixed-Term Contract Position Duration: Eighteen (18) Months Location: Mississauga, ON Job Band: 10 Salary Range: $38.46 - $50.23 / hour Hours of work: 36.25 hr/week Reporting to: Supervisor, Standards This posting is applicable to: Internal & External ApplicantsSkilled Trades Ontario is a Crown...

  • Associate Regulatory Program Director

    1 day ago

    Mississauga, Canada F. Hoffmann-La Roche Gruppe Full time

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Associate Regulatory Program Director

    1 day ago

    Mississauga, Canada F. Hoffmann-La Roche Gruppe Full time

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Associate Regulatory Program Director

    1 day ago

    Mississauga, Canada F. Hoffmann-La Roche Gruppe Full time

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Fund Development Specialist

    6 days ago

    Mississauga, Canada MIAG Centre for Diverse Women & Families Full time

    **Position: Fund Development Specialist** **Project Name: Resilient Communities** **Job Type: Full Time, 35 hours/week** **Duration: 52 weeks (June 2023 - June 2024)** **Remuneration: $27/hr** **Introduction** **Project and Position Description** This project is designed to build organizational financial and professional development capacity post...

  • Business Development Specialist

    4 weeks ago

    Mississauga, Canada Cablelync Utilities Full time

    Overview: We are seeking a highly motivated and results-driven Business Development Specialist to join our team. As a Business Development Specialist, you will be responsible for identifying new business opportunities, building and maintaining client relationships, and driving revenue growth. This is a dynamic role that requires excellent communication...