Associate Director, Regulatory Affairs
1 нед. назад
DirectorRemote
Associate Director role in Regulatory Affairs to support and drive regulatory success in a clinical-stage biopharmaceutical company.
Обязанности
- We are seeking a highly skilled Associate Director, Regulatory Affairs to support and help drive regulatory success and shape the development of life-changing treatments. In this role, you contribute to the development and implementation of a consolidated regulatory strategy (including Regulatory Operations) to help secure and maintain regulatory approvals across the product lifecycle. Success requires a solid understanding of regulatory frameworks, especially with the FDA, and a demonstrated ability to collaborate effectively with cross-functional teams and external resources toward successful submission outcomes.
- The Associate Director will support regulatory planning, execution, and agency interactions. The ideal candidate brings solid global experience navigating complex regulatory environments, particularly in oncology and rare disease, and thrives in a dynamic, mission-driven biotech setting.
- Regulatory Strategy & Execution
- Contribute to the definition of global regulatory strategies and provide cross-functional teams with actionable, tactical guidance to help ensure strategy is updated and executed.
- Anticipate and adapt to changes in regulatory and business environments, ensuring strategies remain aligned with evolving requirements.
- Support end-to-end regulatory planning for submissions including INDs, NDAs/BLAs, briefing packages, and orphan drug applications.
- Support oversight of regulatory consultants and vendors to help ensure timely, compliant, and strategic deliverables.
- Agency Engagement & Communication
- Serve as a regulatory liaison for FDA and other global health authorities, as assigned.
- Prepare materials and support company participation in agency meetings, helping ensure internal teams are well-prepared and aligned.
- Proactively communicate regulatory risks, timelines, and updates to senior leadership and core project teams.
- Prepare company for FDA and other health agency meetings, as required.
- Cross-functional Collaboration
- Represent Regulatory Affairs on Project Teams, Clinical Teams, and Study Teams to align regulatory activities with development goals.
- Communicate regulatory strategy, risk, and milestones clearly across internal teams and with external partners.
- Support and help coordinate cross-functional regulatory submission teams; help ensure high-quality contributions from internal and external stakeholders.
- Support the identification, selection, and oversight of vendors (e.g., CROs)
- Compliance & Operational Excellence
- Ensure global regulatory strategies are compliant with applicable regulations and guidances.
- Develop and maintain regulatory SOPs and best practices.
- Maintain up-to-date regulatory intelligence; monitor global regulatory trends, changes in legislation, and health authority expectations.
- Participate in regulatory due diligence and provide strategic input during business development evaluations.
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 a scientific discipline or equivalent work experience required; advanced degree (MS, PhD, PharmD) preferred.
- 7+ years of experience in the pharmaceutical/biotech industry, with at least 4 years in Regulatory Affairs roles.
- Experience in oncology and across multiple development phases required.
- Demonstrated experience preparing and supporting global regulatory submissions, particularly NDA/BLA filings with the FDA.
- Global regulatory experience preferred.
- Solid working knowledge of the drug development process and global regulatory pathways.
- Good understanding of global regulatory guidelines and their practical application.
- Excellent interpersonal, collaboration, and leadership skills, with the ability to influence cross-functional teams.
- Highly organized with outstanding communication and project management skills to juggle multiple priorities effectively.
- Proactive, analytical, and detail-oriented problem solver with a strong strategic mindset.
- 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.
- Ability to travel up to 10%.
- 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 $170,000-$195,000, 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 |