Senior Associate, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Support the US Regulatory Lead and the Global Regulatory Team within the Regulatory Affairs department.

• Oversee and implement US regulatory submissions as directed by the US Regulatory Lead.

• Handle the preparation, submission, and electronic archiving of documentation for US regulatory filings.

• Aid the Global Regulatory Lead in managing interactions with the Global Regulatory Team.

• Assist with local regulatory tasks, including IND submissions and meetings with agencies.

• Provide and sustain documentation support for CTAs and MAs, encompassing initial filings, amendments, and periodic updates.

• Develop and uphold product regulatory information and history documents utilizing Amgen systems.

• Archive regulatory documents and communications from agencies.

• Collaborate with CROs and partners to facilitate site initiation.

• Complete regulatory forms to aid in communications with agencies.

• Engage with the Global Regulatory Team to support the execution of regulatory strategies.

• Coordinate quality control for regulatory documentation, including briefing materials.

• Draft routine regulatory correspondence, such as annual reports and investigator packages.

• Assist in the development and upkeep of templates.

• Address requests and communicate pertinent issues to the Global Regulatory Team.

• Proactively support regulatory compliance.

⛳️ Requirements

• Master’s degree OR Bachelor’s degree with 2 years of experience in Regulatory Affairs OR Associate’s degree with 6 years of experience in Regulatory Affairs OR High school diploma / GED with 8 years of experience in Regulatory Affairs.

• Excellent communication skills, both verbal and written.

• Capability to comprehend and convey scientific and clinical information.

• Ability to work collaboratively with team members to address challenges and devise action plans.

• Cultural awareness and sensitivity to achieve global outcomes.

• Strong planning and organizational skills.

• Competence in prioritizing and managing multiple tasks effectively.

• Ability to navigate ambiguity.

• Skill in influencing others.

• Sponsorship for this position is not assured.

🏝️ 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 feasible.

• Opportunities for career development.

• Financial plans that provide chances to save for retirement or other objectives.

• Emphasis on work/life balance.