Principal Regulatory Program Director - Devices and Combination Products
About this opportunity
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
As a Principal Regulatory Program Director at Roche Pharma, you will join a high-caliber team that turns regulatory complexity into a competitive advantage across portfolio delivery, capability building, and global policy shaping. Recognized internally and externally for your deep device regulatory mastery, pharmaceutical CMC regulatory experience, and clinical domain knowledge (such as PK/BE bridging), you will serve as a strategic steward across disciplines. Beyond driving core execution, our team architects pioneering, multi-molecule platform frameworks, enables best-in-class technical practices, and upskills the broader CMC organization, transforming how device technology reaches patients worldwide.
The Opportunity
Are you passionate about not only driving high-impact portfolio strategies, but also fostering a collaborative organizational culture that empowers connected teams to deliver their best work? Do you want to directly shape global regulatory policy while upskilling an entire CMC regulatory organization?
Architect and drive global regulatory strategy for complex technologies, including drug-device combination products, novel gene/cell therapy delivery systems, and standalone physical devices. Integrate multi-disciplinary regulatory domains across technical device lifecycle management, pharma CMC drug frameworks, and clinical device domains to ensure seamless execution of the regulatory strategy.
Champion scalable, portfolio-enabling device platform strategies that accelerate development timelines and drive efficiency across multiple pipeline molecules.
Partner closely with key internal stakeholders across Pharma Technical, Pharma Development, Global Pharma Procurement/Supply, Research & Early Development, and Roche Diagnostics.
Provide strategic risk management, regulatory guidance, and high-level decision-making to solve high-impact challenges in alignment with business objectives. Deliver senior-level device regulatory consultation to ensure alignment with global health authority expectations.
Represent Roche Pharma in key external policy venues, engaging directly with global Health Authorities to shape regulatory policy and industry standards.
Author and disseminate strategic external positions through trade groups, international working groups, industry presentations, and publications.
Build internal device regulatory capabilities and evolve operating models, processes, and systems to support rapid device innovation.
Who You Are
You are a visionary and agile regulatory strategist who thrives in dynamic matrix environments. You excel at applying holistic systems thinking to navigate complex, ambiguous regulatory landscapes and possess executive-level communication skills to align senior leaders and cross-functional partners. As a collaborative leader and mentor, you are dedicated to building organizational capabilities, fostering trust, and driving a high-performance team culture.
Further, you possess the following qualifications and experience:
Bachelor's degree in engineering, or a related scientific discipline (advanced degree is preferred).
Minimum 15 years of experience in regulatory affairs, drug development, or technical development within the biopharmaceutical/medical device industry.
Primary focus and extensive global regulatory strategy expertise in drug-device combination products and pharmaceutical/biologic CMC frameworks across the full product lifecycle.
Proven track record of successful health authority interactions, negotiations, and major global drug approvals.
Demonstrated experience building trusted relationships with global regulators, health authorities, and trade associations to shape external regulatory policies.
Willingness and ability to travel up to 10%.
Note: Depending on your background and experience, the level of the position may be hired at the Senior Regulatory Program Director level.
Are you ready to make a difference for our patients? We are looking forward to your application – join us now and become part of our journey!
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 112 comparable Director Regulatory Affairs roles across 44 biopharma companies.
Salary context
50 of 112 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 112 comparable roles
+ 11 more countries
Seniority mix
112 of 112 peers have a known seniority level
Therapeutic area mix
15 of 112 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.