Senior Manager, Regulatory Operations
1 нед. назад
SeniorRemote
Senior Manager role to support and drive regulatory success in a clinical-stage biopharmaceutical company.
Обязанности
- We are seeking a highly skilled Senior Manager/Associate Director, Regulatory Operations to support and help drive regulatory success and shape the development of life-changing treatments. In this role, you will provide operational leadership supporting global regulatory submissions, regulatory information management, regulatory technology, publishing, and Health Authority interactions across development programs.
- This individual will serve as the business lead for Regulatory Information Management, supporting implementation and optimization of Veeva RIM Basics while helping establish internal publishing capabilities and scalable Regulatory Operations processes.
- The successful candidate will combine strong technical Regulatory Operations expertise with systems implementation experience, regulatory publishing knowledge, and a passion for process improvement. This role will partner closely with Regulatory Affairs, Medical Writing, Clinical Development, CMC, Quality, and external partners to ensure high-quality, compliant, and timely regulatory submissions.
- Provide operational leadership supporting global regulatory submissions from planning through archival.
- Serve as the business lead for Regulatory Information Management and Veeva RIM Basics.
- Partner with cross-functional stakeholders to implement standardized document lifecycle management.
- Support the transition to an internal Regulatory Operations publishing model.
- Develop and maintain inspection-ready regulatory information supporting U.S. and global regulatory submissions.
- Partner with the Director of Regulatory Operations to modernize Regulatory Operations through technology and automation.
Другое
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- About Parabilis Medicines
- Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The company’s lead investigational medicine, zolucatetide, is the first and only direct inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin pathway that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseas
- Bachelor's degree in Life Sciences or related discipline, or equivalent combination of education and relevant Regulatory Operations experience.
- Approximately 6-10 years of Regulatory Operations experience within the biotechnology or pharmaceutical industry.
- Extensive experience supporting FDA electronic submissions.
- Strong knowledge of eCTD publishing and submission lifecycle management.
- Experience with Veeva Vault RIM or Veeva RIM Basics.
- Experience supporting regulatory information management systems.
- Experience supporting global submissions, including CTAs and Health Authority interactions.
- Experience training end users on regulatory systems.
- Experience developing Regulatory Operations processes and SOPs.
- Strong project management and organizational skills.
- Excellent communication and collaboration skills.
- Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovative use of AI is a strong plus.
- Able to attend in-person meetings.
- Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.
- Growth-Minded . We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
- In(ter)dependent. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
- Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
- All-In. We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.
- The base salary range for this position is $145,000-$175,000, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.
- As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
- 30 Acorn Park Drive | Cambridge, MA 02140 |