US Regulatory Policy Analyst (Contract Assignment)

アメリカ合衆国, コロンビア特別区, Washington DC
アメリカ合衆国, カリフォルニア州, South San Francisco

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Description

Genentech’s Pharma Technical Regulatory, Policy & International Operations (PTR - PIO) group is looking to hire a Regulatory Policy Analyst for a minimum assignment of at least 1 year. The person in this role will be expected to provide contribution and lead some of the key U.S. Technical Regulatory Policy efforts by building upon the existing and expanding to the new areas as needed to operationalize the regulatory policy and shape the European & US regulatory landscapes. 

Deliverables 

  • Identify avenues of proactive advocacy and lead CMC regulatory policy topics related to New Therapeutic Modalities (e.g., Cell & Gene Therapies), Emerging Technologies, Extractables & Leachables, and other areas with business critical impact 

  • React to Health Authorities (FDA, EMA, ICH) regulatory updates, guidances and assess the business impact to the organization in collaboration with internal and external stakeholders

  • Support engagement with Trade and global Policy efforts within Genentech/Roche

Requirements & Qualifications 

  • Bachelor's degree is a must

  • Advanced degree (MS, PhD. or equivalent) in life sciences (e.g., biochemistry, immunology, etc), chemistry, chemical engineering, or similar scientific field is highly desirable  

  • 3-6 years of experience in the Regulatory Affairs, Regulatory Policy, drug development, technological business innovation or related field

  • Prior experience in Pharmaceutical Industry is desirable

  • Data mining, analysis & interpretation: An ability to understand complex unstructured data, and relate it to both internal and external business drivers 

  • Ability to effectively manage multiple project independently

    Roche is an equal opportunity employer.

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