Director, Regulatory Affairs CMC

Experience Required

1

Minimum Education Required

1

Compensation

$

Hours Per Week

40

Number Of Positions

1

Shift

First Shift (Day)

Job Description

About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.

Please note that this position can be based in San Diego, CA, San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small molecule therapies from development through commercialization worldwide. In this leadership position, you will develop and execute global regulatory CMC strategies that support clinical development, marketing approvals, and lifecycle management across key regions including GCC, LATAM, and APAC. You will serve as the regulatory CMC expert on cross-functional teams, guide global regulatory interactions, and help shape successful development and commercialization strategies for our product portfolio. This is an opportunity to make a meaningful impact on programs that bring important therapies to patients around the world.

Primary Responsibilities

Manages the 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

Manages the timely preparation of high quality CMC sections of INDs, CTAs, NDAs, MAAs and amendments for submission to regulatory authorities supporting the conduct of clinical trials and marketing applications worldwide

Contributes as a key regulatory representative with external parties and acts as a point of contact with regulatory agencies for CMC development, product registration, and life-cycle activities

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 determines applicability to company activities

Other duties as assigned

Education/Experience/Skills

Bachelor’s degree in life science or a related field. An equivalent combination of education and experience may be considered

Targeting 10 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development, with 5 years in a management role

Knowledge and understanding of global regulatory CMC requirements and guidelines

Previous experience in the preparation and submission of the CMC components of IND/CTA filings as well as regulatory authority meeting Briefing Packages and NDA and ex-US MAA submissions

Ability to work in a cross-functional team environment and manage competing priorities

Strong interpersonal skills, attention to detail and excellent organizational skills

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 business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization

Self-directed and resourceful, with the ability to anticipate needs, identify opportunities, and drive work forward independently

Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals

Willingness and ability to travel domestically and internationally as needed

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-RE1 #LI-HYBRID

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$189,700—$237,100 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

EEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

California Applicants: Please see Additional Information for California Residents within our Privacy Policy.

Canadian Applicants: Please see Additional Information for Canadian Residents within our Privacy Policy.

Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy.

Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.

Place of Work

Hybrid

Requisition ID

8734532002

Job Type

Full Time