Regulatory Affairs Senior Manager

2 weeks ago

San Diego, California, United States Contineum Therapeutics Full time

Position Overview:

Reporting to the Senior Vice President of Regulatory Affairs, the Regulatory Affairs Senior Manager or Associate Director will spearhead and engage in regulatory initiatives related to IND/CTA preparation and ongoing maintenance to facilitate both new and existing development programs. This position necessitates a proactive, self-sufficient, and highly driven regulatory expert. The role is based at the company headquarters.

Key Responsibilities:

· Act as the regulatory representative on study and program teams throughout the execution 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).

· Collaborate 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 internal regulatory archives for all clinical programs.

· Lead the development of global regulatory submissions, including requests from regulatory authorities concerning clinical trials, and responses to health authority inquiries for information, as necessary.

· Provide regulatory support for compliance initiatives, including the development of standard operating procedures and documentation efforts.

· Review pertinent clinical documents (protocols, informed consent forms, investigator brochures, site documentation, and required regulatory forms) for compliance with regulatory standards.

· Stay updated on US and international regulations that pertain 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 accordance with the company's core values, policies, and applicable regulations.

Position Qualifications:

· A bachelor's degree is required; an advanced degree is preferred.

· A minimum of 8 years of experience in the pharmaceutical or biotech industry, with at least 4 years focused on regulatory affairs, particularly in clinical regulatory matters.

· Ability to translate regulatory requirements into practical, achievable plans.

· Diverse experience with regulatory activities, including the creation of systems and processes to facilitate efficient and high-quality document submissions to regulatory bodies.

· Strong organizational and project management capabilities, demonstrating the ability to manage and prioritize multiple tasks with exceptional attention to detail.

· Capacity to foster strong relationships with colleagues from various backgrounds and areas of expertise.

· Proven ability to achieve high-performance goals and meet 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.

· A strong desire to learn, coupled with curiosity and a passion for science and patient care.

Contineum Therapeutics offers a competitive total compensation package, along with a supportive team environment. The anticipated salary range for candidates is competitive and will be determined based on various factors, including experience and education. The company provides comprehensive benefits, including opportunities for bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) plan with employer matching. Additionally, the wellness program encompasses medical, dental, vision, and long-term disability coverage, along with unlimited paid time off.

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