Genentech Intern Product Development Regulatory Submissions Group Recruitment
Genentech Intern Product Development Regulatory Submissions Group Recruitment. Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world’s most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society.
INTERN – PRODUCT DEVELOPMENT REGULATORY SUBMISSIONS GROUP
Location: United States of America
Job ID: 202106-116203
Start Date: Fall, September 2021
Work Hours: 40 hours per week
Length of Assignment: 1 Year
Given the current uncertainty of the global pandemic and work from home situation for 2021, this internship is currently planned to be virtual with the option for interns to work remotely from within the U.S. Borders. We will keep candidates informed if this changes.
Product Development – Regulatory Submissions Group (RSG)
The Regulatory Submissions Group (RSG) is part of the product-development regulatory operations (PDRO) organization at Roche/Genentech. We provide coordination, compilation, publishing, and submissions expertise in the preparation of new and existing regulatory applications. Working closely with regulatory and cross-functional colleagues, the team prepares high-quality dossiers that meet the requirements of health authorities worldwide.
In PDR, we seek to deliver global regulatory strategies, intelligence and knowledge. We propose innovative solutions that balance risk and reward for all stakeholders and shape the regulatory environment. We do this by translating Health Authorities (HAs) requirements into dossiers and labels, by providing advice on interactions with HAs, and by taking care of molecules globally from labs to commercialization.
Our PDR Functions (Regulatory Business Office, Regulatory Regions & Policy, Regulatory Strategic Support and Regulatory Therapeutic Areas) contribute to the development of our regulatory strategies and our interactions with Health Authorities. Regulatory colleagues work closely within PDR teams and with teams outside PDR to ensure we support the overall goals of the Product Development organization.
Key Responsibilities and Accountabilities:
- Supports global regulatory submissions processes of low to moderate complexity Plans, coordinates, compiles, publishes, and submits regulatory applications, in compliance with health authority regulations worldwide
- Participates in project planning and is accountable to ensure submission requirements and timing are in alignment with overall project timelines Ensures documents are compliant with company standards, ICH, and other guidelines for incorporation into eCTD submissions using publishing and editing tools
- Partners with Submission Managers to work on more complex submission activities Supports Submission Managers with quality assurance/quality control checks to ensure overall submission quality
- In addition to learning and supporting core submission activities, the intern will have the opportunity to develop a special project to support technical innovation, knowledge sharing, and/or process improvements within PDRO.
Quality Related Job Accountabilities:
- Quality Management: Follows regulations and company policies, and complies with all Standard Operating Procedures
- Analysis: May contribute to routine and ad hoc analysis reporting/metrics
- Continuous Improvement: Demonstrates a continuous improvement mindset, identifying and recommending opportunities to streamline or improve processes
- Training: Completes all assigned mandatory training by the designated due date
PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, interns are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management interns support regulatory program management for one or more development projects. Regulatory Program Management interns participate in and support the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Interns are expected to perform their responsibilities with supervision.
The successful candidate will be nearing completion of a regulatory degree or science (preferably in life sciences) degree; and/or is a graduate student or has recently completed graduate studies (required to have academic studies within 2 years of applying for this position).
- Recent completion or progress toward an advanced degree in sciences, business, or related field Some relevant experience in the pharmaceutical/biotechnology industry is preferred.
- Previous experience in regulatory affairs, quality, manufacturing or other product development functions is a plus.
- Strong computer skills, including Google Suite, Adobe Acrobat, relevant publishing and document management systems/software Fluent English and other language skills as needed