Associate Director, Regulatory Affairs CMC

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Summary
The Associate Director, Regulatory CMC, is responsible for contributing to/assisting with the development and implementation of global regulatory CMC strategies supporting investigational and marketed small molecules therapeutics worldwide. Coordinates global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval of drug candidates and ultimately support the life-cycle of approved products. Represents the regulatory function on multi-disciplinary CMC product development teams and interacts with global regulatory agencies as required. Serves as a resource to the CMC team members for the regulatory requirements, processes, and logistics to conduct global drug development and commercial activities.
Primary Responsibilities
Supports CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements.
Coordinates with R&D, Pharmaceutical Development, Manufacturing, Quality and Regulatory colleagues and other functional areas to develop and implement CMC regulatory strategy.
Organizes and contributes to the timely preparation of high quality CMC sections of INDs/CTAs, NDAs, MAAs and amendments for submission to global regulatory authorities, supporting the conduct of clinical trials and marketing applications.
Contributes as a key regulatory representative with external parties for CMC development activities.
Interacts with regulatory agencies for CMC development activities as required.
Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks.
Participates in ensuring compliance of CMC activities with applicable regulatory requirements.
Evaluates Manufacturing processes and changes, assesses the regulatory implications and supports their implementation.
Maintains current knowledge of the relevant guidelines and regulations and determine applicability to company activities.
Other duties as assigned.
Education and Experience
Bachelor’s degree in a life science or related field.  Targeting at least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development.  An equivalent combination of relevant education and applicable job experience may be considered.
Knowledge and understanding of global regulatory CMC requirements and guidelines.
Previous experience in the preparation and submission of the CMC components of IND/CTA and NDA and ex-US MAA submissions.
Ability to work in a cross-functional team environment and manage competing priorities.
Strong interpersonal skill, attention to detail and excellent organizational, computer, and documentation. Ability to meet deadlines and perform multiple tasks in a fast paced setting
Demonstrated personal initiative, responsibility, flexibility, the ability to work under limited supervision, and ability to handle multiple project assignments.
Skilled at negotiating with/influencing business partners and departmental leaders regarding matters of significance to the department or segments of the organization.
Adept at communicating a clear vision among team members effectively aligning resources to achieve functional area goals.
Physical Requirements
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business issues.
#LI-HYBRID #LI-BG1 In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location. Salary Range $159,700 — $199,600 USD What we offer US-based Employees:
Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
Employer-paid life, disability, business travel and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
13 -15 paid holidays, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave benefit
Tuition assistance
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Location:
San Diego
Job Type:
FullTime

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