Senior Associate – Regulatory Affairs

🕒 2 days ago

🇺🇸 United States – Remote

💵 $84k - $113.6k / year

⏰ Full Time

🟠 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

• Assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization • Coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements • Manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions • Assist the Global Regulatory Lead to manage GRT interactions • Support local regulatory activities (e.g. IND submissions and agency meetings) • Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead • Create and maintain product regulatory information and history documents through Amgen systems • Archive regulatory documents and agency communications • Collaborate with CRO’s / partners to support site initiation • Complete regulatory forms to support agency communications • Participate in GRT to support execution of regulatory strategy • Coordinate QC of regulatory documentation (e.g. briefing materials) • Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages) • Assist in template development and maintenance • Respond to specific requests from and communicate relevant issues to GRT • Actively support regulatory compliance.

🎯 Requirements

• Master’s degree • Or Bachelor’s degree and 2 years of Regulatory Affairs experience • Or Associate’s degree and 6 years of Regulatory Affairs experience • Or High school diploma / GED and 8 years of Regulatory Affairs experience • Strong communication skills - both oral and written • Ability to understand and communicate scientific/clinical information • Ability to collaborate with team members to tackle problems and develop a course of action • Cultural awareness and sensitivity to achieve global results • Planning and organizing abilities • Able to prioritize and balance multiple activities • Ability to deal with ambiguity • Ability to influence others.

🏖️ 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.