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Associate Director, Oncology Regulatory Strategy

2 months ago

Rockville, Maryland, United States GlaxoSmithKline Full time
Job Summary

We are seeking an experienced Associate Director to lead our Oncology Regulatory Strategy team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regional regulatory strategies to support the development and launch of our oncology products.

Key Responsibilities
  • Develop and implement regional regulatory strategies to support the development and launch of oncology products
  • Lead interactions with local and regional regulatory authorities to ensure compliance with global and regional requirements
  • Work closely with cross-functional teams, including commercial, medical, and clinical, to ensure alignment and effective communication
  • Provide regulatory guidance and support to project teams to ensure compliance with regulatory requirements
  • Stay up-to-date with regulatory developments and trends in the oncology space and provide insights to inform business decisions
Requirements
  • Bachelor's degree in Biological or Healthcare Science
  • Minimum 5 years of experience in regulatory affairs, with a focus on oncology
  • Proven track record of developing and implementing successful regulatory strategies
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams
  • Strong analytical and problem-solving skills, with the ability to navigate complex regulatory environments
Preferred Qualifications
  • PhD in Biological or Healthcare Science
  • Experience leading regulatory affairs teams or projects
  • Knowledge of global and regional regulatory requirements, including FDA and EMA regulations
  • Experience with clinical trial and licensing requirements in major countries