Regulatory Affairs Manager
3 weeks ago
Regulatory Affairs Manager
**Location**: Toronto, ON, Canada
**Requisition Number**463**
**Remote**
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.
The Regulatory Affairs Manager (RA) is responsible for partnering cross-functionally with team members/leaders to develop and implement global regulatory strategies to drive pipeline development and lifecycle management activities for contracted clinical programs to ensure successful initiation, execution, submission and approvals for international registrations. Managing all aspects of Regulatory Affairs deliverables, including but not limited to ensuring regulatory compliance and meeting clinical trial and regulatory performance deliverables.. Contributing to the development and growth of the regulatory affairs service provision through collaboration across departments with the establishment and maintenance of client relationships. The RA Manager will be a strategic business partner, providing strategic input into business development proposals, and developing departmental policies, procedures, and processes.
**Responsibilities**:
- Serving as the regulatory primary point of contact for assigned projects and with regulatory agencies.
- Plan, direct, and/or coordinate regulatory activities to ensure compliance with regulations and standard operating procedures.
- Utilize strategic regulatory thinking along with technical expertise to develop, review, maintain and implement new product development/new product introduction/lifecycle management regulatory strategies and plans to ensure continued access to products globally. In line with client objectives, working cross functionally & closely with the project team.
- Preparation, submission and maintenance for products in development, new or existing products to regulatory authorities with international Regulatory Affairs affiliates; for contracted programs to meet or exceed submission deadlines.
- Monitor emerging trends within the global regulatory environment to determine potential impacts on organizational processes.
- Regulatory representative in a working group as required to partner with cross-functional representatives to conduct detailed gap analysis and to communicate assessments of the business impact of new and changing regulations to internal and external stakeholders with senior oversight and support as required.
- Manage and implement process and technical regulatory improvements for the Global Regulatory Affairs organization.
- Review and provide feedback on SOPs, including, but not limited to internal company procedures related to regulatory, clinical, & pharmacovigilance activities, regulatory support during audits/inspections, and educational materials.
- Educate colleagues on regulatory policies and practices.
- Provide guidance to business leadership to optimize strategies across functional areas.
- Exercise highly complex level of independent judgment and execution directly impacting the operational results of the organization; manages, oversees and balances resource allocation across critical projects.
- Establish and ensure deployment of learning initiatives and training for cross-functional partners on current and emerging regulatory and related requirements.
- Ensure that company policies, procedures, and practices comply with appropriate regulatory requirements.
**Qualifications**:
- Minimum requirement of a Bachelor of Science degree in Life sciences, Chemistry, Pharmacy, or equivalent comparable work experience.
- MS/MSc., PhD or other advanced degree is preferred but not essential.
- Minimum 5+ years relevant regulated industry (MedTech/Pharma/CRO) experience **required**.
- Significant experience in all aspects of meeting and communicating with Regulatory/Health Authorities supporting drug development. Prior interactions with the FDA and/or Health Canada, acting as the agent/scientific officer respectively with robust understanding of the eCTD format, **highly desired**.
- Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables.
- Expert knowledge of the applicable regulatory framework as applied to different healthcare sectors such as for Drugs and Medical Devices.
- Previous experience with drug/biologic or combination product regulations strongly preferred.
- Global clinical trial experience **required**.
- Product licensing (NDA/BLA/MAA) and post marketing experience is desirable.
- Strong computer proficiency in MS Office including Outlook, Word, Excel,
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