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Manager, Regulatory Affairs

Santa Monica, CA, USA | Leading Pharmaceutical / Biotech Company

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    Regulatory Affairs
  • Experience:
    5-7 years
Job Description:
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Job Description

Global Regulatory Affairs at Leading Pharmaceutical / Biotech Company, a Gilead Company, is responsible for developing innovative global/regional regulatory strategies and filings that will advance novel medicinal oncology products for patients.


The Manager, Regulatory Affairs is a product facing US regulatory lead role that provides strategic input and day to day guidance from US perspective in support of the development programs at Leading Pharmaceutical / Biotech Company. This includes the development and interpretation of US regulatory Guidance, implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. This person represents the regulatory function on Project Team and Study Team.


Responsibilities (include but are not limited to):

• Develop and implement US regional regulatory product strategies

• Represent the regulatory function on Project Teams and Study Teams

• Provide US regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies

• Plan, prepare, and review submissions to regulatory authorities including FDA to support the conduct of clinical trials (INDs) and/or approval of marketing applications (NDA/BLA) throughout the lifecycle of assigned projects

• Lead regulatory activities for assigned projects in line with regulatory requirements to ensure compliance

• Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements

• Serve as the US Regulatory Leader (USRL) for assigned Regulatory Project Teams in the development of regulatory strategies and support Global Regulatory Lead (GRL) in the development of US regulatory strategies and execution of US regulatory filings

• Monitor, analyze, and disseminate intelligence on US regulatory matters that may affect ongoing development programs

• Provide interpretation of and advice regarding US regulations, directives, and guidance

• Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; develop and maintain a positive working rapport with the regulatory agencies

• Coordinate and prepare responses to requests for information from regulatory authorities

• Develop and maintain pertinent standard operating procedures or local work instructions

• Assist and mentor junior regulatory affairs staff

• Other duties as assigned


Requirements:

• Manager: BA/BS and 5 years, MA/MS, or PhD/PharmD and 3 years of relevant US regulatory (FDA) / drug development experience.

• Knowledge and understanding of US regulations and guidelines

• Previous experience in the preparation and submission of regulatory documents

• Previous experience in attending and leading a team to prepare for major health authority interactions preferred (e.g. FDA pre-IND, pre-NDA/BLA, EOP2 meetings, advisory committee meetings etc.)

• Experience with investigational drugs, including late stage development, and marketed products

• Ability to work in a cross-functional team environment and project teams

• Strong attention to detail and the ability to handle multiple tasks

• Excellent organizational, computer and documentation skills and an ability to prioritize effectively

• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment


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