Senior 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.

At Roche, Technical Regulatory 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:

As a Senior Technical Regulatory Program Director you will lead a significant portion of our regulatory portfolio, playing a pivotal part in ensuring regulatory excellence and driving strategic alignment with our global objectives across diverse therapeutic modalities.  Additionally, you will:

• Spearhead the end-to-end portfolio management for a specific modality, with a strong focus on peptide-based therapeutics, while also supporting small molecules and oligonucleotides. This involves navigating complex regulatory landscapes across different product life cycles, from development to post-market activities.

• Be responsible for developing, communicating, and implementing robust global regulatory strategies. This includes anticipating organizational and/or industry issues, proactively shaping and influencing strategy for complex work packages and cross-functional project teams, and ensuring alignment with global regulatory requirements. You will contribute to the prioritization of our portfolio and/or parts of it (product and non-product portfolio) and ensure that objective and timely feedback is provided to team members.

• Identify and communicate regulatory risks, and you will lead the development and implementation of risk mitigation strategies in close collaboration with technical functions. You will anticipate organizational and/or industry issues to help navigate complex situations.

• Be responsible for the authoring, reviewing, and/or submission of high-quality CMC regulatory documents to health authorities. This involves staying abreast of internal and external developments and trends to maintain a current perspective of implications for all programs.

• Serve as a leader and representative for Pharma Technical Regulatory (PTR) on critical cross-functional teams, including Technical Development Teams (TDTs), Technical Product Teams (TPTs), and Regulatory Affairs Functional Teams (RAFTs). You will build and utilize a strong network of internal and external stakeholders to influence strategies impacting PT, Roche, and/or industry. You will represent (or serve as the delegate) the department needs in senior leadership and governance forums, acting as decision maker as appropriate.

Who you are:

• You have a Bachelor’s degree in a scientific field and 15 years of relevant experience or an advanced degree with 12 years of relevant experience.

• You possess deep skills and expertise across multiple disciplines, with a proven track record in CMC/CMC Regulatory ideally including peptides and can communicate sophisticated CMC issues with ease

• You have significant experience and demonstrated strategic leadership across a variety of high priority and/or complex PTR/PT/Pharma outcomes, drug development projects, and modalities.

• You are recognized as an industry leader and subject matter expert across Pharma on key topics, and represent Roche/Genentech on related external industry collaborations.

• You possess expertise across a variety of high priority and/or complex PTR/PT/Pharma outcomes, drug development projects, and modalities.

• You have expertise leading internal and external projects with an ability to generate meaningful outcomes in lesser defined areas (e.g., policy, shaping, innovation).

• You are a regulatory expert and possess the confidence and aptitude to represent Roche/Genentech in health authority interactions or external engagements.

• You have a positive reputation within and outside of PT due to credibility, expertise, and extent of network.

• You have demonstrated effective matrix leadership skills, an agile strategic approach, and exceptional communication abilities.

• You are comfortable taking measured risks, experimenting with new insights, and navigating ambiguity.

This is a remote based role.

Relocation benefits are not approved for this posting.

The expected salary range based on the primary location of California is $181,000 (min) - $258,600 (mid) - $336,200 (max).  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.