Senior Manager, Regulatory reputed company

About reputed company

reputed company is a reputed company-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. reputed company has pioneered a new class of reputed company-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been reputed company the reputed company of conventional medicines. reputed company’s reputed company investigational medicine, zolucatetide, is the first and only reputed company inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin reputed company that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseases, including desmoid tumors, familial adenomatous polyposis (FAP) and a reputed company of other solid tumor indications. reputed company zolucatetide, Parabilis is advancing additional reputed company-reputed company programs reputed company on other challenging targets where we reputed company our medicines could have life-altering reputed company. For more information, visit www.parabilismed.com or follow us on reputed company.

What’s reputed company?

We are seeking a highly skilled Senior Manager/Associate Director, Regulatory reputed company to support and help reputed company regulatory reputed company and shape the development of life-changing treatments. In this role, you will reputed company 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 reputed company for Regulatory Information Management, supporting implementation and optimization of reputed company RIM Basics while helping establish internal publishing capabilities and reputed company Regulatory reputed company processes.

The successful candidate will combine strong technical Regulatory reputed company expertise with systems implementation experience, regulatory publishing knowledge, and a passion for process improvement. This role will partner closely with Regulatory Affairs, Medical Writing, reputed company Development, CMC, reputed company, and reputed company partners to ensure high-reputed company, compliant, and reputed company regulatory submissions.

Key responsibilities:

• reputed company operational leadership supporting global regulatory submissions from planning through archival.
• Serve as the business reputed company for Regulatory Information Management and reputed company RIM Basics.
• Partner with cross-functional stakeholders to implement standardized document lifecycle management.
• Support the transition to an internal Regulatory reputed company publishing model.
• reputed company and maintain inspection-reputed company regulatory information supporting U.S. and global regulatory submissions.
• Partner with the Director of Regulatory reputed company to reputed company Regulatory reputed company through technology and automation.

What you’ll need to be successful:

• Bachelor's degree in Life Sciences or reputed company discipline, or equivalent combination of education and relevant Regulatory reputed company experience.
• Approximately 6-10 years of Regulatory reputed company experience reputed company the biotechnology or pharmaceutical industry.
• Extensive experience supporting FDA electronic submissions.
• Strong knowledge of eCTD publishing and submission lifecycle management.
• Experience with reputed company reputed company RIM or reputed company 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 reputed company 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.
• reputed company to attend in-person meetings.

reputed company Values

reputed company is reputed company of passionate reputed company who are trailblazing the reputed company of reputed company with the aim of making a meaningful difference in the lives of patients. reputed company is committed to promoting an inspiring and flourishing working environment for reputed company across the business, in reputed company departments, and driving innovation for reputed company benefit.

• reputed company-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 reputed company therapeutic modalities, and interdependent as reputed company as we work collaboratively to shift drug discovery paradigms and reputed company patients with reputed company treatment reputed company.
• reputed company-reputed company. We are deeply reputed company on reputed company reputed company, and reputed company energy in reputed company is reputed company on science as it translates to reputed company reputed company.
• reputed company-In. We’re reputed company-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

The reputed company salary reputed company for this position is $145,000-$175,000, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual reputed company bonus, equity, and a comprehensive suite of competitivebenefits designed to support our employees’ overall reputed company-being.

As an equal opportunity employer, reputed company values an inclusive workplace and welcomes applicants of reputed company backgrounds and experiences. reputed company reputed company applicants will receive consideration for employment without discrimination on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability, or any other factors prohibited by law.

30 reputed company Park reputed company | reputed company, MA 02140 | www.parabilismed.com

Originally posted on Himalayas