Global Regulatory Strategy Leader - CMC

“We are focused on results. Those that can be measured. And those measured in ways beyond numbers. We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcomes. Our innovation means trying new things, learning from our mistakes, and consistently refining our approach. Our strategies help us define our path to success, but our effectiveness is based in the aggregate power of our initiatives to impact holistic change.”

 -Bill Gates and Melinda French-Gates

The Bill & Melinda Gates Medical Research Institute (Gates MRI) is a non-profit biopharmaceutical development organization primarily dedicated to the development of impactful biopharmaceutical interventions for diseases that disproportionately affect the world’s poorest populations, diseases that combined cause five deaths every minute.  Headquartered in Cambridge MA, the Institute is designed to advance novel drug, biologics, and vaccine candidates through late-stage development and registration.  The Institute encompasses experienced biopharmaceutical development professionals across regulatory, CMC, and clinical functions as well as comprehensive operational support functions.  The Institute’s programs are managed by its internal teams and functional areas in collaboration, working with partners across the global health ecosystem.

The Institute is based on five core “mantras” that are embedded within the organization and its people:

• Urgency: Execute with excellence to maximize impact.

• Collaboration: Establish empowered teams to drive our bottom line: lives saved.
• Innovation: Build on the known, uncover the new, achieve the unprecedented.
• Rigor: Drive the science, focus on the details, and execute with the highest quality.
• Courage: Dare to confront the world’s most significant global health challenges.

Though the Institute is a diverse group of passionate change-makers, creative fixers, and relentless advocates, these five core values are universally adopted by all who join it with the personal goal of improving the health and wellness of the world’s most vulnerable populations.

As a wholly owned subsidiary and separate legal entity of the Bill & Melinda Gates Foundation, the Institute partners scientifically, operationally, and financially with the foundation to leverage the foundation’s ongoing support and contributions toward the achievement of global health equity.

The Institute is currently composed of 160 employees and leverages dedicated vendor partnerships and consultant staff to assure the right skills are in place at the right time while retaining the flexibility to adapt as required by the development program portfolio.

The Gates MRI offers hybrid work arrangements, a 50% mix of on-site and work-from-home, and a competitive relocation package for those looking to move to the Cambridge, MA area.  Remote employment is not offered for this role at this time.

THE POSITION

Reporting to the Head of Global Regulatory Affairs (GRA), the Global Regulatory Strategy Leader (GRSL) CMC is responsible for developing and implementing global regulatory strategies to advance the development of the diverse candidates in the Gates MRI portfolio.  Developing sound, innovative regulatory approaches, implemented with transparency and urgency, is essential to achieving the immediate and long-term goals of GRA.

The GRSL CMC will be a recognized expert in global CMC regulatory affairs, have direct involvement with the development and licensure of product candidates worldwide and is comfortable working cross-functionally on product development teams, representing Regulatory CMC. The GRSL is responsible for developing, documenting, and updating the CMC regulatory functional plan and all Health Authority engagement plans required to progress the Gates MRI portfolio of candidates from early preclinical development to human proof of concept and beyond.

The GRSL CMC will be a key participant in decision making, will have accountability for the strategic regulatory direction for CMC activities, and help build the organization.  The GRSL CMC will participate in due diligence and partnering activities, building for the future.

• Working closely with the Leaders from Gates MRI departments develop an agreed global regulatory functional plan for CMC aspects that meets regulatory requirements. 
• Working in partnership with the GRSL Product Development Team (PDT) representative, align on the overall regulatory strategies that will be employed for each candidate modality (vaccine, drug, biologic, probiotic)
• Proactively plans and leads interactions with Health Authorities.  Provide leadership to cross-functional teams in planning regulatory documents and preparing for regulatory interactions (e.g., INDs, NDAs, IMPDs, CTA’s, pre-IND meeting packages, scientific advice [or the equivalent], etc.).  Communicates outcome of meetings and next steps. 
• Working closely with Clinical Operations, provides input on documentation required for clinical trials.  As we work in a highly outsourced model, you may participate in the selection of vendors that can provide robust and compliant regulatory support including regulatory aspects of eTMF, in countries where clinical trials are planned.
• Maintains proper documents, procedures, and quality activities to ensure adequate oversight of all delegated activities.
• Creates documentation for regulatory authorities in high, middle and low-income countries related to potential clinical trials and licensure.
• As a cross-functional leader; represents the regulatory CMC perspectives of GRA with Clinical Development, Clinical Operations, CMC, Legal, Discovery, and Quality.
• Acts as the SPOC for all CMC regulatory aspects of the PDT, working in alignment with the GRSL representative assigned to the PDT
• Liaises with key stakeholders such as the WHO, Health Authorities and others to utilize new approaches that may serve to facilitate regulatory advancement of our candidates.
• Works with the cross-functional translational medicine teams and others to create a robust package of regulatory records/information for transfer of products to other partners for late stage development. 
• Keeps pace with trends in the regulatory environment, anticipating and communicating changes in regulatory requirements, and supporting the cross-functional translational medicine teams in understanding the implications for ongoing development of product candidates.

QUALIFICATIONS

The successful candidate will be an innovative, sophisticated, and collaborative leader who thrives in a “get it done” type of environment with a strong track record of hands-on experience in Regulatory Strategy with the following mix of personal and professional characteristics:

• 10+ years of experience in product development in industry, with 8+ years of that experience being in regulatory strategy.
• Minimum of MS but high preference for advanced degree (PhD, MD) in a related scientific field.
• Late-stage development vaccine regulatory experience is essential.
• Early-to-late-stage development in small molecules and biologics is preferable.

Technical

• Previous experience in conduct of all regulatory affairs activities including meeting submissions, IND and clinical trial applications (or the equivalent), and regulatory filings; knowledge of regulatory pathway programs such as breakthrough, accelerated approval and related designation programs in the US and the equivalent in non-US jurisdictions.
• Lead, develop and implement CMC regulatory strategies that ensure on-time and high- quality global submissions for investigational applications.
• Develop regulatory strategy and execute in the preparation of timely responses to CMC regulatory questions, pre-meeting packages, and interactions with Heath Authorities as needed for the assigned project.
• Demonstrated evidence of how to resolve conflicting input from different regulatory authorities.
• Demonstrated evidence of successful timeline management and successfully moving investigational products through regulatory approvals.
• Experience in working with regulatory authorities in low to middle income countries.
• Expert in understanding regulations of ICH, FDA, and EMA.
• Experienced knowledge of GLP, GMP, and GCP regulations.

• Proven ability to effectively utilize and manage external regulatory consultants and CROs.  

Strategic

• Proven effectiveness in a matrixed organization. Anticipates and helps teams to anticipate regulatory risks and works collaboratively to address those risks. 
• Excellent oral and written communications skills.
• Works well under pressure.

Organizational Leadership

• Experienced advisor to senior leadership; with track record of significant contribution to product development.
• Experience building capability, both internally within own organization and externally with a range of partners is required.
• Ability to navigate a wide range of operational and strategic issues, including industry, government, legal, IT, financial, and HR.
• Knowledge of strategy development and implementation to design performance management systems consisting of goals, targets, and monitoring process.
• Experience in pioneering the start-up of new organizations while embracing any tasks that need to get done.
• Demonstrated passion for the Gates MRI’s values with a commitment to deliver results against our mission.

In recognition of high-wage market differences such as the Cambridge, MA area where this position is located, the salary range for this role is $230,000-$270,000 USD.   As a mission-driven organization, we strive to balance competitive pay with our mission.  New hires salaries are typically between the range minimum and the salary range midpoint. Actual placement in the range will depend on a candidate’s job-related skills, experience, and expertise, as evaluated during the interview process.

#TH-LI1

Hiring Requirements

As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.

Candidate Accommodations

If you require assistance due to a disability in the application or recruitment process, please submit a request here.

Inclusion Statement

We are dedicated to the belief that all lives have equal value. We’re committed to creating a workplace where employees thrive both personally and professionally. We also believe our employees should reflect the rich diversity of the global populations we aim to serve—in race, gender, age, cultures and beliefs—and we support this diversity through all of our employment practices.

All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.