Role Description The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams toĀ -Ā optimize product development and regulatory approvals in International countriesĀ -Ā develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management.
Roles & Responsibilities
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, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans).
Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio.
Under general 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 clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing.
Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the 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.
Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams.
Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations.Ā
Partners with 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 to share product development status.
Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function.
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.
Basic Qualifications and Experience
Doctorate degree OR 8 or more years of relevant regional regulatory experience OR
Master's degree and 9 or more years of relevant regional regulatory experience OR
Bachelor's degree and 10 or more years of relevant regional regulatory experience
Functional Skills
Must-Have Skills ā¢Ā Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products ā¢Ā Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes ā¢Ā General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.
Good-to-Have Skills ā¢Ā Ability to resolve conflicts and develop a course of action leading to a beneficial outcome ā¢Ā Cultural awareness and sensitivity to achieve results across country, regional and international borders.
Soft Skills ā¢Ā Strong communication skills, both oral and written ā¢Ā Ability to understand and communicate scientific/clinical information ā¢Ā Ability to work effectively with global, local and virtual teams ā¢ High degree of initiative and self-motivation ā¢Ā Planning and organizing abilitiesĀ ā¢Ā Ability to manage multiple priorities successfully ā¢Ā Team-oriented, with a focus on achieving team goals ā¢Ā Good negotiation and influencing skills.