Amgen Regulatory Lead EU – Oncology in Uxbridge, United Kingdom
Regulatory Lead EU – Oncology
As we are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules – and we are looking for top talent to ensure these molecules become medicines and realize their potential for helping patients.
This role will support one or more oncology products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), you will be developing and executing regional regulatory strategies and managing effective agency interactions in the oncology therapeutic area for Europe and strategic input into the filing plans for several expanded European markets.
Regulatory Lead overview
Shaping and executing the approved regional strategy for assigned programs
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
Ensure regulatory compliance, with a focus on patient safety
This role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff
Advising the GRT on regional considerations in developing strategy
Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
Strategy and Execution
Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
Leads development of regional regulatory documents and meetings in accordance with GRT strategy
Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
Directs the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
Manages regional label negotiation activities
With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)
Communicates regulatory strategies as appropriate such that expectations are understood.
Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management
Develop predictions for expectations and risks associated with outcomes by regulatory agencies
Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments)
Communicate and ensure alignment of regional management before GRT strategy decisions
Partner with regional management and peers to ensure consistency in procedures and agency interactions
Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products
Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
Evaluates and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labeling
Health Authority Interactions
Act as contact and create relationships with agency staff on specific product assignment
Region Specific Activities
US: Advises and supports promotion group regarding applicability of data for product communication in the US
EU: Review and approve promotional and non-promotional materials for use in international region
APAC, LACAN, EEMEA: Lead the product lifecycle for individual countries per national agency requirements
APAC, LACAN, EEMEA: Work through the regional leads to manage distributor markets
Required Knowledge and Skills:
Regulatory knowledge in national regulations
Working with policies, procedures and SOP’s
Experience with national legislation and regulations relating to medicinal products
Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
Understanding of drug development
Scientific / Technical Excellence:
Good communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues, anticipate regulatory agency responses to strategy
Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Location: Uxbridge or Cambridge
Competitive salary & comprehensive benefits package including bonus scheme
Amgen is an equal opportunities employer.
Amgen is a full-scale biotechnology company that integrates the nimble and innovative culture of a small biotech with the stability, heritage and experience of a large pharmaceutical company. For decades we’ve been delivering essential supportive care therapies for oncology patients
For nearly four decades, Amgen has been at the forefront of providing the oncology and hematology communities with novel therapies that have changed patients’ lives. Our portfolio, as a whole, ranks above industry average in terms of the number of first-in-class medicines we have brought to market, with two-thirds of our medicines gaining this distinction versus the industry average of one-third.
At Amgen, innovation is more than just a buzzword. It’s how we give new options and hope to patients with serious illnesses – from widespread cancers to orphan diseases like acute lymphoblastic leukemia (ALL). Our heritage and our future are the pursuit of novel therapies that patients, physicians and caregivers value most.
We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules – and we need top talent to ensure these molecules become medicines and realize their potential for helping patients. We need collaborative and innovative world-class individuals to ensure these molecules become medicines and that they will strive to reach their full potential while helping patients.
Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms – Bispecific T Cell Engagers (BiTE®s), CAR Ts, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules – across many targets and more than a dozen tumor types.
Many of these innovative modalities/technologies are not only firsts for Amgen, but also for the entire biotechnology field. By joining our team, you will help us seize the opportunities that come with paving new roads – roads that ultimately lead to directly serving oncology patients.
In our mission to serve patients, speed is absolutely critical. We’re rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team – working toward our mission of advancing high potential programs for cancer patients around the world.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.