Career Category
Regulatory*
Job Description
The Regional Regulatory Lead (Sr. Manager) is assigned to lead Amgen products in Maghreb Cluster (Algeria, Morocco, Libya, Tunisia). The product(s) assigned have complex programs/strategies and high impact to Amgen.
First point of contact for GM Maghreb and Maghreb Leadership Team Partnership with distributors and agents across cluster Lead shape drive and execute.
Provide
Guidance and Leadership on regional mechanisms to optimize product development and regulatory approvals.
Develop and execute the
regional regulatory strategy and regional regulatory plans.
Ensure and support
regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments).
Support and advise on the local label strategy and
alignment to CDS/reference label.
Build
effective relationships and
communication paths across global, regional, local and functional organizations.
Enable
efficiencies and seamless execution across the region countries. Provide
SME support in localization projects initiatives.
STRATEGY AND EXECUTION
Advises Global/Regional teams on regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives. Provides regulatory direction/expertise on regional 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 and manages regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio and in compliance with global/regional filing plans and local regulatory requirements. With minimal supervision, leads the development of regional regulatory strategy documents (regional 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. May coordinate the collection of functional documents in support of regulatory applications. Leads the internal discussions related with Agency meetings and in accordance with GRT strategy (and communicates outcomes back to GRT and others, as applicable). Directs the development of the regional product label by collaborating with the Labeling Working Group/Regional Review Committee to define commercial objectives in the context of available and expected scientific data, regulatory guidance, precedents and competitor labeling. Manages the regional label submission strategy and timelines, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports the approval and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs). Ensures/supports regulatory product compliance (e.g. RIM, PMCs, pediatric and other agency commitments). Reviews and approves promotional and non-promotional materials for use in the region. Advises and supports other groups on the materials data, as applicable. Supports process improvement initiatives and metrics.
COMMUNICATION AND COLLABORATION
Participates as a member of the Global Regulatory Team (GRT), Evidence Generation Team (EGT), Labeling Working Group (LWG), Clinical Study Team (CST), Regional Brand Team and others, as applicable. Shares regulatory information and implications with the GRT and other Global teams on an ongoing basis and provides advice on regional considerations. Participates in LWG/ELB meetings with advice on local deviation requests. Partners with the regional brand team and 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 the product development. Partners with peer to ensure consistency in procedures. Acts as contact and maintains positive relationships with Agency staff on specific product assignment (if applicable).
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(s) Regional Regulatory Leads at more junior levels.
Scientific and 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. Awareness of the registration procedures/challenges in the region for CTAs, MAs and all lifecycle management activities. Knowledge and experience in the regional regulatory environment relevant for product area and development stage. Understanding of drug development. Able to anticipate regulatory Agency questions and potential response.
Others
Demonstrate strong team work 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.
Pharmacist Degree with min 8 years of regulatory experience, also presents team/people managing experience
Degree and in-depth regulatory experience and/or related to the region. In-depth knowledge of regional countries legislation and regulations relating to medicinal products.
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