Job Description

Career Category Regulatory

ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller, and longer. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
The Business Performance Senior Manager is a member of the Transformation Execution team. This team is responsible for helping leaders improve performance by defining performance measures and targets, establishing a portfolio of initiatives to drive improvement, developing business cases, and executing the initiatives.
The senior manager will lead workstreams for mergers, acquisitions, and licensing integrations (MAL) across all deal phases from a regulatory life cycle perspective. They serve as the subject matter expert in cross-functional and business development forums. They continuously improve both the MAL operating model as well as supporting other process improvement activities across the GRAAS process infrastructure.
Roles & Responsibilities:

• Strategic Leadership & Execution

• Represent GRAAS at cross-functional MAL and Business Development-related forums, providing strategic input and thought leadership
• Form and lead sub-function teams for integration and licensing activities, ensuring alignment with strategic objectives
• Drive strategic solutions to complex business problems, leading analyses and negotiations with key decision makers
• Lead Regulatory workstreams across all deal phases

• Serve as Lead for all product licensing work, including integrations into and transitions out of Amgen
• Closely partner with Regulatory Affairs (RA) Therapeutic Area Integration Project Lead and advise/instruct them on end-to-end process and details of planning and execution of acquisition integration
• Act as their delegate as needed in cross-functional meetings
• Assist with pre-deal close GRAAS due diligence
• Develop and manage GRAAS integration workplan
• Draft and manage any new controlled documents unique to the integration, such as Quality Integration PLANs and bridging process GDEs
• Lead and manage cross-company controlled document mapping and disposition
• Identify gaps and risks to integration
• Work closely with the Information management and change management teams, to ensure system changes and effective adoption of the change
• Act as a Point of Contact and Subject Matter Expert

• Serve as member of the Amgen Corporate Integration Management Team
• Forming and leading the team for effective execution
• Serve as SME with licensing company and schedule and facilitate cross-company meetings as required
• Maintain MAL status documentation and QMS bridging documents, manage risks/dependencies, represent regulatory in integration forums for thought leadership
• Drive Continuous Improvement

• Optimise the MAL resources for GRAAS, embedding best practices and compliance with corporate and departmental expectations
• Lead other continuous improvement projects to support the GRAAS process infrastructure.

ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller, and longer. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
ABOUT THE ROLE
The Senior Manager of Regulatory Affairs at Amgen oversees regulatory compliance initiatives within the company. They are responsible for ensuring all company procedures and products adhere to state and federal regulatory requirements.
Group Purpose
International Regulatory Affairs provides regulatory leadership/ expertise for the development, registration, and lifecycle management of all Amgen molecules.
Job Summary
The International Regulatory Lead (Sr. Manager) is assigned to lead one or more Amgen products. The product(s) assigned have complex programs/strategies and high impact to Amgen.
Provide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals.
Develop the international regulatory strategy and contribute to Global regulatory plans.
Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments).
Support and advise on the local label strategy and alignment to cCDS/reference label.
Build effective relationships and communication paths across global, regional, local, and functional organizations.
Enable efficiencies and seamless execution across the international countries.
Provide SME support to process improvement projects, as assigned.
KEY ACTIVITIES
Strategy & Execution
Advises Global teams on regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives.
Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, expedited regulatory designations, compassionate use and pediatric plan).
With minimal supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio.
With minimal supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate.
Provides and maintains CTA/MA documentation. May author documents/redact documents to support a regulatory filing.
Leads the internal discussions related to Agency meetings and in accordance with GRT strategy (and communicates outcomes back to GRT and others, as applicable).
Directs the development of the international product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance, precedents and competitor labeling.
Manages the international label submission strategy, leads negotiation activities with cross-functional teams, and is accountable for label deviation requests and outcomes.
Supports Local Regulatory teams in triaging queries from health authorities and, where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management.
Advises and supports other groups on the review of promotional and non-promotional materials, as needed.
Supports process improvement initiatives and metrics.
Communication & Collaboration
Participates as a member of the Global Regulatory Team (GRT), Evidence Generation Team (EGT), Labeling Working Group (LWG), Clinical Study Team (CST), and others, as applicable.
Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations.
Participates in LWG/ELB meetings with advice on local deviation requests.
Partners with the peers to agree on product strategy including projected submission and approval time.
Maintains regular communications with the local teams to ensure alignment on strategy and keep the countries informed of status on product development.
Partners with peers to ensure consistency in procedures.
Builds effective relationships and communication paths across the Global and Local elements of the GRAAS function.
Regulatory Research
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.
Mentoring
Mentors and/or advises other International Regulatory Leads at more junior levels.
KNOWLEDGE & SKILLS
Scientific & Technical
Knowledge of Regulatory principles.
Working with policies, procedures and SOP's.
Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
General knowledge of national legislation and regulations relating to medicinal products.
General awareness of the registration procedures/challenges in the region for CTAs, MAs and all lifecycle management activities.
Knowledge and experience in the international regulatory environment relevant for product area and development stage.
Understanding of drug development.
Able to anticipate regulatory Agency questions and potential responses.
Others
Demonstrate strong teamwork ability.
Good communication skills - both oral and written.
Good negotiation and Influencing skills.
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.
Cultural awareness and sensitivity to achieve results across both regional, country and international borders.
Education & Experience
Master's degree (scientific area) and 10 years of directly related experience OR
Bachelor's degree (scientific area) and 12 years of directly related experience
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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Skills Required