Senior Regulatory Documentation Scientist

South San Francisco, California
United States

Job ID: 2578060108

Download PDF

Return to Search Results

The Position

Position Purpose:

To prepare regulatory documents for submission to regulatoryauthorities within subject area (clinical/safety). Working with minimalguidance, the Senior Regulatory Documentation Scientist takes accountabilityfor delivering regulatory documents, working effectively and closely with key contentowners in the relevant functions. The Senior Regulatory Documentation Scientistapplies scientific writing, document and project management expertise andcontributes to the functional excellence of regulatory documentation throughprocess management.


Major Responsibilities and Accountabilities:

  • Manages the preparation of a suite of regulatory documentse.g. Clinical Dossier, suite of Safety Documents
  • Leads Writing/Editing Team for preparation of ClinicalDossiers/Safety Reports
  • Reviews documents to ensure compliance with documentationquality standards, regulatory requirements and consistency of messages acrossall documents for a product/ within a clinical dossier
  • Prepares specifications for outsourced work (writing/reviewof documents) and serves as Roche liaison for project purposes
  • Plans and creates timelines for the production of assigneddocuments e.g. Clinical Dossier/Suite of Safety documents. Ensures proper planningand resourcing of all documents assigned to Writing/Editing Team including work tobe outsourced
  • Actively contributes to best practices and continuousimprovement within RegulatoryDocumentation. Represents the group in functionaland cross functional  initiatives/projectswhen required
  • Acts as a mentor to new members/less experienced membersof the Documentation group
  • In addition, assumes the responsibilities of a RegulatoryDocumentation Scientist

Who You Are


Bachelor’s degree or equivalent.

Advanced degree in life sciences or other relevant fieldpreferred.

Experience, Knowledge, Skills

  • Demonstrated clear, high-quality scientific writing stylein the English language
  • Experience in regulatory affairs or related functions indrug development, knowledge of international regulations, and previousexperience of authoring and/or editing regulatory documentation.
  • Aptitude or proven ability to guide the work of others
  • Ability to independently analyze and synthesize data froma broad range of disciplines
  • Project management skills: consistently achieves multipletasks and goals on-time
  • Strong interpersonal and verbal communication skills
  • Influencing skills: can influence without authority.
  • Ability to work effectively in a team environment,establishes strong collaborative relationships, resolves conflict by creating an atmosphereof openness and trust
  • Thinks through problems clearly and logically

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.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

Return to Search Results