Compliance Advisor II supporting enterprise - wide compliance operations at AltaMed. Involves audits, training, policy drafting, and compliance queries with healthcare focus.
About the role
- Global Regulatory Affairs Manager at GSK responsible for developing and executing global regulatory strategies. Collaborate with cross-functional teams to ensure compliance and successful submissions.
Responsibilities
- Proactively develop or implement regulatory strategies to ensure the submission and approval of clinical trial applications and other deliverables within agreed timescales.
- Ensure effective interaction with cross-functional teams, global/regional counterparts, and local operating companies.
- Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
- Assess precedent, regulatory intelligence, and the competitive environment to inform and refine regulatory strategies.
Requirements
- Minimum of a Bachelor’s degree in biological or healthcare science.
- Minimum of 1 year experience in the drug development process within regulatory affairs.
- Proven ability to manage development, submission, and approval activities in different regions globally.
- Minimum of one year of experience in clinical trial requirements in at least one region (EU or US) and ideally familiarity with other key agency processes globally.
- Advanced Scientific Degree (PhD, MD, PharmD) is preferred.
- Minimum of two years of experience in Oncology (Hematology or Solid Tumor) regulatory affairs is preferred.
Benefits
- Health care and other insurance benefits (for employee and family)
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave
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