Lead compliance programs for IESO ensuring adherence to regulations while supporting business and stakeholder engagement in electricity sector.
About the role
- Regulatory Affairs Manager ensuring licenses for clinical trials and market products at Amgen. Leading regulatory submissions and providing strategic regulatory guidance for product development.
Responsibilities
- Work to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
- Support one or more products from a regional regulatory perspective.
- Plan and manage regulatory submissions for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
- Implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provide content guidance for regional regulatory documents and meetings in accordance with global strategy.
- Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans).
- Support regional label negotiation activities.
- Participate in the development, and execution of regional regulatory product strategies.
- Develop predictions for expectations and risks associated with outcomes by regulatory agencies.
- Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
- Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
- Evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling.
Requirements
- Scientific Degree and demonstrated experience in a similar role
- Regulatory principles
- Working with policies, procedures and SOP’s
- Knowledge of legislation and regulations relating to medicinal products
- Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals.
- Knowledge of drug development
- Knowledge of and experience in regional regulatory environment
- Strong communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and prevent potential issues
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Benefits
- Growth opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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