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Our client is a leader in the manufacturing space seeking a Regulatory Affairs Specialist. This role will report the to the Director of Manufacturing Operations and will provide comprehensive regulatory compliance expertise for current and proposed products regulated by FDA, EPA & Health Canada.

Role Responsibilities:

  • Develop and implement regulatory strategic plans for product registration and lifecycle management.
  • Lead the preparation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and ad hoc reports to regulatory bodies, and maintain the life cycle of currently marketed regulated products.
  • Track registrations and effectively communicate with leadership team on a projects progress to ensure all critical timelines are met.
  • Lead the preparation and review of responses of regulatory queries in relation to clinical efficacy and safety as needed.
  • Lead interactions with Health Canada from pre-submission and throughout the submission review cycle to ensure prompt regulatory approval, optimal labeling and implementation of local regulatory strategies.
  • Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and deadlines.
  • Develop effective working relationships with business partners, clinical professionals and federal/provincial authorities to support regulatory strategies as needed.
  • Monitor regulatory changes and applicable regulatory requirements, Identify impact of changes and/or regulations on operations and products and communicates changes across the organization
  • Provide regulatory guidance and input to internal partners on messaging, labelling, SDS development and marketing materials.
  • Perform supplier and internal audits in accordance with procedures and deadlines
  • Maintain and establish product documentations, certificates of analysis and product specification documents.
  • Monitor Innocore’s regulatory landscape, interpret changes, analyze gaps and conduct impact assessment, and participate/lead implementation into new systems and/or processes.
  • Actively contribute to improving critical departmental processes and to initiatives to enhance the internal work environment.
  • Support Quality and Compliance activities as needed (e.g. change control, audits, etc…as needed)

Qualifications:

  • Bachelors of Science (Master in Science preferred), or a related discipline (Quality Management)
  • Certificate in Regulatory Affairs would be an asset
  • Experience working for a consulting firm preferred
  • 2+ years working in a similar role
  • Knowledge of various acts & regulations including FDA, EPA, NNHPD, PMRA, CFIA, NSN (CEPA), and NHP as asset
  • In-depth knowledge of Canadian, US, and international regulations for disinfectants, hand sanitizers and pesticides is a definite advantage
  • Participated in internal and external regulatory audits
  • Ability to interact and negotiate with various governing authorities
  • Demonstratable experience with the following product compliance guidelines and organizations: GHS, WHMIS, TDG, and cGMP
  • Excellent analytical abilities
  • Understanding of risk management
  • Effective organizational skills, strong attention to detail and accuracy in order to successfully oversee regulatory initiatives, multitask and handle fluctuating workloads
  • Well-developed interpersonal and communication skills (oral, written, computer-proficient) with the ability to present ideas, solutions, and strategies in a clear and concise manner
  • Adaptable to changing environment, client, and project needs
  • Self-motivated, possess initiative, and able to work productively with minimal supervision
  • Excellent project management and follow-up skills, deadline-oriented with a strong ability to prioritize tasks
  • Strong computer knowledge and Office software skills – Microsoft Word, Excel, Outlook

Contract Info / Information sur le contrat
  • Job ID / No. du Poste: 23990
  • Open Positions / Postes Ouverts: 1
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