Sr Mgr Regulatory Affairs

Sr Manager - Gen Med / Biosims International Regulatory Lead

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

• Doctorate
  OR
• Master's degree (scientific area) and 6 years of directly related experience
  OR
• Bachelor's degree (scientific area) and 8 years of directly related experience

Experience (Preferred)

• 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.