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Amgen logo
Amgen

#WeareBiotech

Senior Associate – Regulatory Affairs

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

9 days ago

Salary

$84.0K - $113.6K / year

Seniority

Senior

Bachelor Degree2 yrs expEnglish

Job Description

Senior Associate – Regulatory Affairs

Amgen

• 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.

Job 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.

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