Technical Regulatory Program Director New Modalities

And as the world evolves, so do we. For over 125 years, we have tackled some of the most sophisticated challenges in healthcare.

Are you eager to join a team dedicated to bringing new medicines to patients? We are seeking a Technical Regulatory Program Director to join our Pharma Technical Regulatory (PTR) department.

This position plays a crucial role in developing new medicines and making them accessible worldwide. We provide strategy, expertise, and mentorship to offer top-tier technical regulatory support for the chemistry, manufacturing, and controls (CMC) components of clinical trial licensure applications, new market applications, and post-approval changes. We collaborate with health authorities and industry groups globally and are integral to our internal development and marketed product teams.

The Opportunity:

• You support different types of modalities (small molecules, oligonucleotides, peptides) and product life-cycles with a focus on peptides

• Develop, communicate and implement robust regulatory strategies that align with global regulatory requirements

• Identify and communicate regulatory risks; develop and implement risk mitigation strategies in collaboration with technical functions

• You are responsible for authoring, reviewing and/ or submission of high-quality CMC regulatory documents to health authorities

• You represent PTR on cross-functional teams, such as Technical Development Teams (TDTs), Technical Product Teams (TPTs) and Regulatory Affairs Functional Teams (RAFTs) and work with diverse partners and personalities

Who you are:

• Bachelor's degree in a scientific field, preferably; advanced degree highly desirable

• Confirmed experience in CMC regulatory submissions and strategy in different lifecycle stages, ideally including peptides

• Effective matrix leadership skills, an agile strategic approach, and strong communication abilities

• Ability to lead, handle and communicate sophisticated CMC issues efficiently

• Demonstrated experience in successfully guiding complex global regulatory strategies and effectively managing high-stakes regulatory interactions with health authorities

• Comfortable taking measured risks, experimenting with new insights, and navigating ambiguity

Join us in our mission to improve global health - apply your expertise and passion to make a real difference. We offer a collaborative and inclusive environment where you can thrive and grow.

Relocation benefits are not available for this posting.

This is a remote based role.

The expected salary range for this position based in California is $135,300 - $251,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.