Associate Director

Description:

Key Responsibilities:

§ Develop and execute on regulatory strategy, submission, and compliance to bring CNS therapeutics to the clinic

§ Lead and manage regulatory process, including regulatory document preparation, assembly, and submission, for US and ex-US regulatory submissions (i.e. pre-INDs, INDs, ex-US scientific advice, and CTAs)

§ Serve as primary Health Authority contact, including participating in meetings and assisting team in preparations

§ Provide regulatory guidance and advice for lead and future programs

§ Develop and implement policies and procedures for regulatory record keeping

§ Help select CRO and other regulatory consultants/personnel, as needed, and manage their activities to ensure deadlines and milestones on company regulatory projects are achieved

§ Assume responsibility for resolving issues with regulatory impact resulting from audits of external vendors/CROs and health authority inspections

§ Contribute to cross-functional decision-making and execution as regulatory lead

§ Help develop a Regulatory Affairs infrastructure, including SOPs and implementation of process improvements, to enhance the efficiency of operations

§ Other duties to support regulatory activities as may be reasonably assigned from time to time.

Education, Experience, and Qualities Required:

§ Bachelor’s degree in a relevant discipline required; advanced degree preferred

§ A minimum for 3 years in biotechnology or pharmaceutical industry required

§ Experience in US and ex-US regulatory strategy and guidelines required

§ Experience in drug development for CNS disorders preferred

§ Experience with oligonucleotide and/or small molecule drug development preferred

§ Strong organizational skillset with ability to manage multiple concurrent workstreams

§ Excellent verbal and written communication skills

§ Ability to work collaboratively in a fast-paced, dynamic environment

§ Passion for bringing new therapies to serve patients with unmet medical needs