Auto req 13841BR
Job Posting Title Exec Dir Regulatory Affairs - Bone TA
Career Category Regulatory
Employee Subgroup Executive FT
Country (State/Region) United States - California
Location (City) Thousand Oaks
Amgen Job Description This role leads the Bone Therapeutic Area team within Amgen's Regulatory Affairs department. The Therapeutic Area Head (TAH) manages a team responsible for developing and executing regulatory strategies and managing effective regulatory agency interactions to achieve desired regional labeling and global registration.
The TA Head will represent Global Regulatory Affairs as a member of the Therapeutic Area Steering Committee (TASC) within the Amgen Commercialization Process in addition to providing high-level strategic guidance to Global Regulatory Leaders.
Key Activities:
• Consult with Global Regulatory Leaders (GRL) in development of global regulatory strategies and approve Global Regulatory Plan and Global Strategic Plan
• Global oversight of all regulatory aspects between and across products within a therapeutic area
• In collaboration with Amgen regional staff, interact and negotiate with key regulatory agency officials in the execution of Global Strategic Plans
• Oversee core regulatory and cross-functional teams to ensure effective agency interactions
• Provide technical expertise in inspections, negotiate the need for inspections, review responses to observations
• Provide input to TASC, senior management review committees, governance boards, other cross-functional product meetings
• Provide guidance to team on regulatory strategies, precedence and risk management
• Consult and review contingency planning/risk assessment for products within a therapeutic area development strategies and agency interactions
• Monitor, assess and communicate impact of relevant global regulations, guidance’s current regulatory environment and competitor labeling
• Assist corporate training on regulatory affairs and contribute to the design and content development of department training programs
• Provide coaching, mentoring, and development of staff
Basic Qualifications • Doctorate degree and 6 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies
OR
• Master’s degree and 10 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies
OR
• Bachelor’s degree and 12 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies
AND
• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Preferred Qualifications • Advanced degree
• Regulatory submissions experience specific to bone products
• Experience interacting with senior regulatory agency representatives
Knowledge and Skills leveraged in the role:
• Strong communication skills – both oral and written
• Ability to understand and communicate scientific/clinical information
• Demonstrated ability to lead teams
