Senior Associate, Regulatory Affairs
The Opportunity:
The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspect of the department and will support interactions with global regulatory authorities.
Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements, coordinate the content and development process (planning, creation, review, and approval) of selected regulatory documentation for inclusion in submissions to global health authorities.
Compile regulatory submissions that meet ICH or FDA requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.
Prepare and manage routine submissions and related activities. Define and manage detailed timelines to ensure timely delivery of high-quality, compliant, accurate and complete regulatory submissions.
Assist in the development and implementation of SOPs and systems to track and manage product-associated events.
Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assist in assessment of regulatory implications for development and approval. Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.
Work with manager on acquisition and development of required regulatory skills and knowledge.
Required Skills, Experience and Education:
Bachelor’s degree in a relevant field.
Two or more years prior experience in a Regulatory Affairs department at a drug or biologics company.
Some familiarity with regulatory requirements for development of drug and biological products, including FDA regulations and guidance, and ICH guidelines.
Willing to advance my knowledge of regulatory practice through classes, certifications, webinars.
Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in an electronic document management system.
Preferred Skills:
Experience in oncology drug development.
Experience with supporting the preparation and submission of large complex regulatory submissions, including NDA’s.
Excellent written and verbal communication skills.
#LI-JC1 #LI-Hybrid
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
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Base Pay Salary Range
$120,000—$150,000 USD