Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA preparations and maintenance to support new and ongoing development programs. This role requires an independent, self-directed, and highly motivated regulatory professional. Position will be located onsite at the company headquarters in San Diego.
Position Responsibilities:
- Represent regulatory on study and program teams throughout study conduct and product development.
- Prepare and/or review regulatory documents required for product development (e.g. New IND/CTAs, DSUR, health authority meetings and briefing documents, iPSP/PIP, NDA/MAA)
- Collaborate closely with project management to ensure regulatory timelines are established and met in accordance with corporate goals.
- Provide oversight of regulatory submissions vendor to assure technical accuracy, compliance, completeness, and timely regulatory agency submissions.
- Maintain internal company regulatory archives for all clinical programs.
- Lead development of global regulatory submissions, including requests from regulatory authorities relating to clinical trials, and responses to health authority requests for information, as required.
- Provide regulatory support for company compliance initiatives, including SOP development, and documentation initiatives, etc.
- Review relevant clinical documents (protocol, informed consent form, investigator’s brochure, and site documentation, and required regulatory forms) for regulatory compliance.
- Keep current on US and OUS regulations that apply to company products and processes.
- May support other global submission activities as appropriate, independently or in collaboration with the SVP, Regulatory Affairs
- Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.
Position Requirements:
- Undergraduate degree required; advanced degree preferred.
- 8+ years of experience in pharmaceutical/biotech, with minimum of 4 years of experience in regulatory affairs including clinical regulatory affairs.
- Ability to translate regulatory requirements into practical achievable plans.
- Diverse experience with regulatory activities including creation of systems and processes to support efficient and high-quality submission of documents to regulatory bodies.
- Strong organizational and project management skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail.
- Ability to build strong relationships with co-workers of various backgrounds and expertise.
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
- Effective interpersonal and communication skills; must be a collaborative cross-functional team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.
- Strong learning orientation, curiosity, and passion for science and patients.
We offer a competitive total compensation package, as well as working in a supportive team environment.
The anticipated salary range for candidates who will work in San Diego, CA is $165,000 to $190,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.
Contineum offers competitive compensation and benefits, including the opportunity for annual bonuses, stock options, Employee Stock Purchase Program, and a 401(k) with an employer match. In addition, the comprehensive wellness program includes medical, dental, vision, and LTD coverage and unlimited PTO.
Please submit your resume or CV and supporting documents to info@contineum-tx.com.
