Get Hired Faster With COMPANY_NAME!
Don't you ever think you landed here by any accident, You are here because you are searching for something bigger. You know what?
- A better Job
- A better Future
- A better Knowledge
- A better Paycheck
- A greater Path to walk on.
And COMPANY_NAME is here to give you exactly what you've been missing for so long. The reality is that most job seekers chase job postings, but successful job seekers attract job offers by chasing the accurate information. Therefore, that's the shift COMPANY_NAME is going to help you make. Here are the top 10 ideas to up-skill yourself, so lean in to begin:
1: COMPANY_NAME Smart Tools and Direct Employer Connections Help Speed Up Your Hiring Process
COMPANY_NAME is a career-changing advantage that most seekers never get access to. Imagine...
- Instead of applying for job after job and still not getting any callbacks, you suddenly bump into a tool that can do the heavy lifting for you.
- Instead of wondering, "What do employers actually want?", you are getting insights straight from the employer's desk.
- Instead of hoping your resume gets noticed, it’s kept on the table of decision-makers who are hiring right now.
That's the difference COMPANY_NAME makes. Our tools will let you reach employers directly, which automatically speeds up your hiring process.
2: With Better Matches, Real-time Job Alerts, and Direct Employer Responses, COMPANY_NAME Helps Many Candidates Secure Interviews and Job Offers Within 15 to 30 Days!
How does COMPANY_NAME make this possible?
On COMPANY_NAME, you get notified for roles aligned with your profile right from the start. When an employer posts a role that matches your qualifications and skills, you’ll know first. When you apply early, your chances of getting noticed and shortlisted increase by 20%.
COMPANY_NAME also offers direct employer responses—no more waiting for weeks. Here you engage with hiring managers who are actively looking for candidates.
When all these features combine in one place, you move from your first match to your first interview within days. And ultimately, from application to offer—all within 15 to 30 days!
3: The Type of Resume You Need to Get Priority Placement
With COMPANY_NAME, you don’t just need a resume—you need a strategy. A system that pushes your name to the right tables. We’ll show you exactly how the most successful candidates take initiative and get noticed.
4: Browse Full-Time, Part-Time, and Freelancing Roles With COMPANY_NAME
The job market isn’t one-size-fits-all—and your career shouldn’t be either. COMPANY_NAME gives you access to a wide range of opportunities including full-time, part-time, and freelancing roles all in one place.
5: COMPANY_NAME Helps You Grow Your Career
COMPANY_NAME provides insights, tools, and role-matching that help you find the right direction, the right skills, and the opportunities aligned with your ambition.
6: The Easiest Way To Find A Job
COMPANY_NAME cuts the noise, the endless scrolling, and the confusion. With accurate matches, direct employer connection, and real-time updates, you get a clear and simple path from application to interview.
7: Find Roles That Offer Growth, Culture & Benefits
COMPANY_NAME helps you find roles where you grow, feel supported, and thrive—not just survive. With us, you discover opportunities that elevate your professional life.
8: Get Support With Resume, Interviews & Career Planning
COMPANY_NAME provides expert guidance on resumes, interviews, and planning so employers instantly recognize your strengths and value.
9: Your Future Starts Today
COMPANY_NAME gives you everything you need—tools, guidance, and opportunities—to step forward confidently and begin a new chapter where your potential is seen and supported.
10: Get Hired Within 15 to 30 Days With COMPANY_NAME
COMPANY_NAME follows a smart, strategic, and proven approach that gets your profile noticed faster and moves you toward interviews and offers within 15 to 30 days.
Senior Director, CMC Regulatory Affairs, Oncology
About the position
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. Moderna is solidifying its presence in Marlborough, Massachusetts, home to one of our key technical development and manufacturing centers. Here, we're pushing the boundaries of mRNA science by anchoring critical operations that support the global development and supply of our transformative therapies. Marlborough offers a unique environment that blends hands-on innovation with large-scale impact. Join our team in Marlborough and play a pivotal role in shaping the next chapter of Moderna’s mRNA platform. You will lead Moderna’s Regulatory CMC strategy for its oncology portfolio, managing a team of experts and steering regulatory submissions through all development stages. This position is a hybrid of strategic vision, operational precision, and team mentorship—positioned to drive regulatory excellence in support of Moderna’s mission to transform patients’ lives through mRNA technology. You will serve as a senior voice in cross-functional governance structures, own regulatory interactions with global authorities, and ensure streamlined execution of complex deliverables across manufacturing, quality, and development. Your leadership will directly impact how quickly and safely Moderna brings its oncology therapies to market. This role offers the opportunity to engage closely with digital and AI tools that are shaping the next generation of regulatory science and operational excellence.
Responsibilities
- Lead development and execution of regulatory CMC strategies for oncology submissions including IND, CTA, BLA, and MAA filings.
- Oversee a team of regulatory professionals via direct and matrix management structures.
- Serve as the key CMC regulatory contact in cross-functional governance forums for oncology programs.
- Provide strategic guidance to manufacturing and quality teams on complex regulatory and technical issues.
- Lead preparation and review of agency correspondence to ensure submission-readiness and adherence to global regulatory expectations.
- Champion cross-functional initiatives that simplify and enhance business processes across Regulatory, Technical Development, and Quality.
- Mentor, develop, and inspire regulatory professionals, ensuring high team engagement and technical growth.
- Act as primary liaison for Regulatory CMC interactions with health authorities.
- Support creation and refinement of global CMC templates and knowledge assets.
- Represent Moderna’s oncology programs with rigor, urgency, and precision, helping to accelerate delivery of transformative therapies to patients.
- Delivering robust interpretation of domestic and international regulatory guidance to internal teams.
- Driving alignment within the broader regulatory affairs function on shared priorities and global strategies.
- Ensuring internal compliance with GxP regulations, SOPs, data integrity standards, and documentation expectations.
- Executing activities in accordance with assigned training and requalification plans.
- Leading or contributing to initiatives that explore the use of Generative AI and digital tools to enhance regulatory science and operational efficiency.
- Applying good documentation practices to ensure readiness for audits and inspections.
- Contributing to a culture of learning and adaptability, aligned with Moderna’s high-speed innovation environment.
Requirements
- MS/PhD degree in a scientific/engineering discipline preferred
- 10+ years of experience in the pharmaceutical/biotech industry.
- 8+ years of experience in Regulatory CMC, including DMF/ASMF submissions
- Strong knowledge of current US, EU and ROW regulations.
- Strong experience with CTD format and content for regulatory filings.
- Demonstrated ability to learn in order to gain a strong understanding of FDA, EMA and ICH guidelines
Benefits
- Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investment opportunities to help you plan for the future
- Location-specific perks and extras