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About the Role

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.

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

Requirements

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

Skills

CMC Regulatory Affairs
Small molecule drug development
Global regulatory CMC requirements and guidelines
Preparation and submission of CMC components of IND/CTA filings
Regulatory authority meeting Briefing Packages
NDA and ex-US MAA submissions
Cross-functional team collaboration
Managing competing priorities
Interpersonal skills
Attention to detail
Organizational skills
Meeting deadlines
Performing multiple tasks
Personal initiative
Responsibility
Flexibility
Working under limited supervision
Handling multiple project assignments
Negotiating with business partners or management
Influencing senior level leaders
Self-directed
Resourceful
Anticipating needs
Identifying opportunities
Driving work forward independently
Creating and communicating a clear vision
Aligning resources
Achieving functional area goals

Location

San Diego, CA
San Francisco, CA
Princeton, NJ

Work Type

Hybrid

Experience Level

10 years of progressively responsible experience in CMC Regulatory Affairs
5 years in a management role

Education Level

Bachelor’s degree in life science or a related field

Salary/Compensations

$189,700—$237,100 USD

Benefits

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

About the Company

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.

Equal Opportunity

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 talentacquisition@acadia-pharm.com 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.