Manager – United States Regulatory Strategy, General Medicine

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $112.7k - $152.5k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Execute U.S. regulatory strategy and deliverables for assigned programs and represent the region on global teams. • Plan and manage U.S. regulatory submissions (e.g., clinical trial and marketing applications) aligned with global filing plans and U.S. regulatory requirements. • Implement product-related regulatory tactics and activity plans in accordance with U.S. legislation, regulations, and internal standards. • Provide content guidance for key U.S. regulatory documents and meetings consistent with Global Regulatory strategy (e.g., briefing content, submission components). • Support U.S. labeling development in collaboration with the Labeling Working Group (LWG), incorporating scientific data, guidance, and precedent; support U.S. labeling negotiation activities. • Provide regulatory guidance on U.S. mechanisms and pathways to optimize development (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use where applicable). • Obtain and maintain clinical trial authorizations and marketing application approvals, including support for Responses to Questions (RTQs) and other agency feedback. • Communicate regulatory strategy and expectations within the team (e.g., GRT, affiliates/stakeholders) and work with line management to assess likelihood of success, expectations, and risks. • Ensure ongoing regulatory compliance for assigned products (e.g., IMR accuracy, PMCs/commitments, pediatric and other agency obligations); escalate issues proactively. • Maintain and apply U.S. regulatory intelligence: monitor evolving legislation/guidance; research precedent and history; assess and communicate potential impact (including competitor labeling where relevant). • Support Health Authority interactions by acting as an agency contact as appropriate, documenting outcomes, and contributing to risk/contingency planning consistent with global strategy. • Partner with cross-functional teams to support alignment and execution, including U.S.-specific considerations for data use in product communications (as applicable).

🎯 Requirements

• Doctorate degree OR Master’s degree and 2 years of directly related experience OR Bachelor’s degree and 4 years of directly related experience OR Associate’s degree and 8 years of directly related experience OR High school diploma / GED and 10 years of directly related experience. • Regulatory submissions experience and experience interacting with regulatory agencies (FDA) • Working knowledge of U.S. legislation/regulations relating to medicinal products and applicable regulatory principles • Understanding of drug development and the U.S. registration pathway (e.g., marketing applications, post-approval changes, extensions/renewals) • Experience supporting regulatory strategy for programs in general medicine, metabolic disorders, endocrinology, or related therapeutic areas. • Foundational scientific understanding of cardiovascular and metabolic diseases • Strong written and oral communication skills; ability to communicate scientific/clinical information clearly • Ability to anticipate issues, evaluate risks, and contribute to practical contingency planning • Ability to resolve conflicts, influence without authority, and drive alignment across teams • Cultural awareness and ability to operate effectively across global/regional teams.

🏖️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and vision coverage • life and disability insurance • flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.