Quality Compliance Senior Manager at Amgen strengthening R&D Quality Management System in labelling and regulatory affairs. Leading safety processes and managing compliance metrics for pharmaceutical/biotech industry.
About the role
- Lead global regulatory strategy and manage cross-functional teams at GSK to shape regulatory approaches. Drive compliance and resource planning in a hybrid work environment.
Responsibilities
- Lead development and execution of regulatory strategy for assigned therapeutic assets across global regions.
- Coordinate and represent the therapeutic group in cross-functional development and regulatory governance forums.
- Manage regulatory interactions with health authorities and support advocacy to influence evolving requirements.
- Ensure regulatory compliance across product lifecycle.
- Support resource planning, budgeting, and team capability development within the therapeutic regulatory group.
- Drive continuous improvement of regulatory processes and metrics to reduce cycle time and improve quality.
Requirements
- Bachelor’s degree in life sciences, pharmacy, medicine, or a related field.
- At least 8 years of regulatory affairs experience in the pharmaceutical or biotech industry.
- Experience leading a successful NDA or BLA submission.
- Experience leading or managing matrixed teams across regions or functions.
- Experience with health authorities including the FDA and supporting regulatory interactions.
- Experience of stakeholder engagement and cross-functional collaboration.
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
- annual bonus
- eligibility to participate in our share based long term incentive program
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