Regional Regulatory Senior Associate
US – California – Thousand Oaks; United Kingdom – Field/Remote
Amgen is searching for a Regional Regulatory Senior Associate to join our Intercontinental Regional Regulatory group. This role can be based on our main corporate campus in Thousand Oaks, CA or the UK (Uxbridge and Cambridge offices).
This group facilitates patient access to Amgen products in Intercontinental countries through executing on our Intercontinental filing plan; providing strategic regional regulatory guidance on regional regulatory mechanisms to optimize product development and approvals; aligning with key cross-functional partners; integrating into Amgen’s commercialization process, and continuously improving our processes and developing our talent.
The Regional Regulatory Senior Associate will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.
Key Activities for this Senior Associate Regulatory Affairs include:
- Assist Regional Regulatory Lead to support regional regulatory activities
- Provide and maintain CTA/MA documentation support (e.g. initial application and amendments) in collaboration with Regional Regulatory Lead
- Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications
- Review regional component of the Global Regulatory Plan/Regional Regulatory Plan and provide input to operational deliverables
- Ensure compliance with submissions to regulatory agencies
- Coordinate collection of functional documents in support of regulatory applications
- As appropriate participate in GRT to support execution of regulatory strategy
- Coordinate QC of regulatory documentation
- Provide primary authorship to routine regulatory correspondence
- Complete regulatory forms to support agency communications
- Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
- Support process improvement initiatives, standards development, and metrics
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to GRT
- Develop Regulatory Position with teams
- Actively support regulatory compliance
- Support the development and execution of GRT goals
Master’s degree in a science discipline (e.g Biology, Pharmacy)
Bachelor’s degree science discipline (e.g Biology, Pharmacy) and 2 years of regulatory experience
Associates degree science discipline (e.g Biology, Pharmacy) and 6 years of regulatory experience
High school diploma / GED and 8 years of regulatory experience in a science environment
- Strong knowledge of regulatory principles
- Understanding of how to work with policies, procedures and SOP’s
- Knowledge of national legislation and regulations relating to medicinal products
- Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals
- Knowledge of drug development
- Good communication skills – both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and prevent potential issues
- Knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Understanding of regulatory activities and their touch points
- Cultural awareness and sensitivity to achieve results across both regional country and International borders
- Knowledge of IC countries legislation and regulations relating to medicinal products
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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