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Regulatory Affairs Senior Manager
2 months ago
Position Overview:
Reporting directly to the Senior Vice President of Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will spearhead and engage in regulatory initiatives related to IND/CTA preparations and ongoing maintenance to facilitate both new and existing development programs. This position demands a proactive, self-sufficient, and highly driven regulatory expert. The role is based at the corporate headquarters.
Key Responsibilities:
- Act as the regulatory representative on study and program teams throughout the lifecycle of studies and product development.
- Draft and/or evaluate regulatory documents essential for product advancement (e.g., New IND/CTAs, DSUR, health authority meetings and briefing documents, iPSP/PIP, NDA/MAA).
- Work closely with project management to ensure that regulatory timelines are established and adhered to in alignment with corporate objectives.
- Oversee regulatory submission vendors to ensure technical precision, compliance, completeness, and timely submissions to regulatory agencies.
- Maintain the internal regulatory archives for all clinical programs.
- Lead the creation of global regulatory submissions, including addressing requests from regulatory authorities regarding clinical trials and responding to inquiries from health authorities as necessary.
- Provide regulatory guidance for compliance initiatives, including the development of Standard Operating Procedures (SOPs) and documentation efforts.
- Review pertinent clinical documents (protocols, informed consent forms, investigator brochures, site documentation, and necessary regulatory forms) for compliance with regulatory standards.
- Stay informed on both US and international regulations applicable to company products and processes.
- May assist with other global submission activities as appropriate, either independently or in collaboration with the Senior Vice President of Regulatory Affairs.
- Execute all responsibilities in alignment with the Company's core values, policies, and applicable regulations.
Qualifications:
- Bachelor's degree required; advanced degree preferred.
- 8+ years of experience in the pharmaceutical or biotechnology sector, with a minimum of 4 years in regulatory affairs, particularly in clinical regulatory affairs.
- Ability to convert regulatory requirements into practical, achievable plans.
- Diverse experience in regulatory activities, including the establishment of systems and processes to support efficient and high-quality document submissions to regulatory bodies.
- Strong organizational and project management skills, demonstrating the ability to manage and prioritize multiple tasks with meticulous attention to detail.
- Capacity to foster strong relationships with colleagues from various backgrounds and areas of expertise.
- Proven ability to meet high-performance goals and deadlines in a dynamic environment.
- Excellent interpersonal and communication skills; must be a collaborative team player with a proactive attitude and the ability to identify and implement innovative solutions to complex technical challenges.
- Strong desire for learning, curiosity, and a passion for science and patient care.
Contineum Therapeutics offers a competitive total compensation package and a supportive team environment.
The anticipated salary range for candidates is $165,000 to $190,000, with the final salary dependent on various factors including experience and education.
Contineum provides competitive compensation and benefits, including opportunities for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) plan with employer matching. Additionally, a comprehensive wellness program is available, covering medical, dental, vision, and long-term disability, along with unlimited paid time off.
