Regulatory Compliance Specialist overseeing compliance for Arc'teryx raw materials and goods. Collaborating across teams to uphold regulatory frameworks and ensure consumer safety with legal standards in focus.
About the role
- Director Respiratory Regulatory CMC at Viatris managing global CMC submission compliance and stakeholder interactions. Fostering relationships and driving regulatory strategies in respiratory products.
Responsibilities
- Cultivates sustainable & effective relationships across a network of stakeholders, partners and customers to drive regulatory strategies and policies
- Uses technical and scientific knowledge in the preparation and analysis of global CMC submission documentation
- Guides preparation of CMC submission documentation
- Serves as a liaison with regulatory agencies and provides oversight for the fulfillment of agency commitments
- Responsibilities include lead in preparations and interactions for regulatory authority meetings
- Manages, leads and contributes significantly to the respiratory portfolio, individual projects and initiatives within cross-functional project teams
- Monitors the external competitor and regulatory environment and builds knowledge into project strategies
- Performs other duties or equivalent duties for other product types as assigned
- Serves as the primary reviewer of global CMC strategic plans and documentation/submissions
Requirements
- Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)
- Mandatory hands-on experience in Regulatory CMC for respiratory/inhaled products
- High level of knowledge of development & commercial activities and cGMP’s to assess technical, scientific & regulatory merits of CMC information, commitments and data
- Specific knowledge in development and life cycle management of respiratory/inhaled products is highly preferred
- Extensive technical, functional, and industry knowledge in shaping project strategy
- Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle
- Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally
- Proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders
- Advanced skills in written & oral communications (mandatory)
- Computer literacy with Microsoft Office Suite and Documentum-based applications
- Prior experience managing projects and matrixed teams and/or serving as a people manager
- Ability to participate in interactions with regulatory authorities to respond to requests
Benefits
- Competitive salaries
- Benefits
- Career progression opportunities
- Work-life balance initiatives
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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