Amgen
#WeareBiotech
Senior Director, Global Regulatory Affairs – Obesity
Location
United States
Posted
118 days ago
Salary
$216.8K - $259.6K / year
Seniority
Senior
Postgraduate Degree5 yrs expEnglish
Job Description
• Support products in the Obesity Therapeutic Area
• Provide Regulatory leadership to cross-functional teams for high complexity programs
• Independently develop a comprehensive regulatory strategy for one or more high complexity programs
• Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets
• Represent GRA on the product team and other key commercialization governance bodies
• Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan
• Identify and communicate regulatory risks
• Lead the planning and implementation of global regulatory filings
• Monitor and assess the impact of relevant global regulations
• Ensure consistency of evidence-based global product communication
• Clearly and succinctly communicate regulatory strategies and associated risks to the organization
• Lead GRTs and product teams in formal and informal communications with regulatory agencies
Job Requirements
- Doctorate degree and 5 years of regulatory experience in biotech or science OR Master’s degree and 8 years of regulatory experience in biotech or science OR Bachelor’s degree and 10 years of regulatory experience in biotech or science
- Contemporary obesity experience desired
- Demonstrated ability to lead regulatory aspects of highly complex programs in late development
- Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
- Ability to lead and build effective teams
- Strong communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and mitigate against future strategic issues and uncertainties
- Ability to resolve conflicts and develop a course of action
- Cultural awareness and sensitivity to achieve global results
- Planning and organizing abilities
- Able to prioritize and manage multiple activities
- Ability to make complex decisions and solve problems
- Ability to deal with ambiguity
- Organizational savvy
- Negotiation skills
Benefits
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
Compliance118 days ago
Full TimeRemoteTeam 1,001-5,000Since 2016H1B Sponsor
Senior Analyst, Compliance for Crypto.com ensuring regulatory compliance in the US and Canada
Compliance118 days ago
Full TimeRemoteTeam 1-10Since 2024H1B No Sponsor
Compliance Manager and BSA Officer developing OpenFX's compliance program across the Americas
United States
Compliance119 days ago
Full TimeRemoteTeam 10,001+H1B No Sponsor
Compliance Specialist ensuring CMS requirements are met in residential and non-residential settings
Principal/Sr Medical Editor – Regulatory Documents, Copy Editing, QC
Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
Compliance119 days ago
Full TimeRemoteTeam 10,001+H1B Sponsor
Medical Editor ensuring compliance with FDA and EU guidelines
