Senior Associate, Regulatory Affairs

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $84k - $113.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

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 Lead and Global Regulatory Team in the Regulatory Affairs organization • Coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead • Manage and execute preparation, delivery, and electronic archiving of documentation for US regulatory submissions • Assist the Global Regulatory Lead in managing Global Regulatory Team interactions • Support local regulatory activities, including IND submissions and agency meetings • Provide and maintain CTA/MA documentation support, including initial filings, amendments, and periodic reports • Create and maintain product regulatory information and history documents through Amgen systems • Archive regulatory documents and agency communications • Collaborate with CROs and partners to support site initiation • Complete regulatory forms to support agency communications • Participate in the Global Regulatory Team to support execution of regulatory strategy • Coordinate quality control of regulatory documentation, including briefing materials • Author routine regulatory correspondence, including annual reports and investigator packages • Assist in template development and maintenance • Respond to requests from and communicate relevant issues to the Global Regulatory Team • 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 • Sponsorship for this role is not guaranteed

🏖️ 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 • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance