Amgen European Regulatory Affairs Lead - Oncology in Uxbridge, United Kingdom
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.
Title (Role) Regulatory Lead EU - Oncology
Organization Global Regulatory Affairs
This role will support one or more oncology products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
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
To ensure regulatory compliance, with a focus on patient safety
As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade)
This role is accountable for:
Executing the approved regional strategy for assigned programs
Representing the region
This role is responsible for:
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)
Share regulatory information and implications with the GRT colleagues on an ongoing basis and provide advice on regional considerations
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
Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management
Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy-includes contingency regulatory planning/risk assessment
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
Supports communication/collaboration between direct reports who are regional leads and regional head for program issues requiring next level engagement
Provides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals.
Location: Uxbridge or Cambridge
Competitive salary & comprehensive benefits package including bonus scheme
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
Communication of regulatory strategies such that expectations are understood.
Anticipate regulatory agency responses to strategy
Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Cultural awareness and sensitivity to achieve results across both regional country and International borders.
Amgen is an equal opportunities employer.