US Regulatory Policy Analyst (Contract Assignment)

Job description

·  Job facts

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

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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

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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

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

Requirements & Qualifications

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Bachelor's degree is a must

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

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

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Prior experience in Pharmaceutical Industry is desirable

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

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Ability to effectively manage multiple project independently

Roche is an equal opportunity employer.
Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

·  Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.