Regulatory Affairs Manager
Regulatory Affairs Manager
Posted on :
21-08-2025
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1 Vacancy
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Job Description
Work Flexibility: Onsite
Regulatory Affairs Manager- candidate can come from Quality or Regulatory background.
This is a permanent role with full Stryker benefits- bonus pension and healthcare for employee and their family.
Key Areas of Responsibility:
- Assesses links between global societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
- Develops and updates global regional and multi-country regulatory strategy and aligns regulatory strategies to organizational strategies
- Provides guidance to integrate regulatory considerations into global product entry and exit strategy
- Identifies regulatory pathways for initial product designs and provides input to internal stakeholders
- Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes
- Assesses all requirements and potential obstacles for market access and distribution (federal provincial/territorial/state reimbursement purchasing groups etc.) and develops solutions to address anticipated obstacles
- Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
- Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan conditional approval breakthrough therapy)
- Negotiates with regulatory authorities on complex issues throughout the product lifecycle
- Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
- Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
- Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
- Provides strategic input and technical guidance on global regulatory requirements to product development terms
- Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
- Evaluates proposed preclinical clinical and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
- Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
- Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases
- Provides knowledge and critical analysis of preapproval inspections GCP inspections and clinical investigator relationships
- Provides regulatory guidance on strategy for proposed product claims/labeling
- Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
- Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions
- Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process
- Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees
Education / Work Experience:
- BS in a science engineering or related Advanced degree preferred
- Minimum of 8 years experience
- People Management experience required
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Travel Percentage: 20%Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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