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Senior Manager, Regulatory CMC
Job Description
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate life. For 30 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson's disease psychosis and the first and only FDA-approved drug for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X.
Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
The Sr. Manager, 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 7 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.
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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.
What we offer you (US-Based Employees):
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- 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
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- 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 single 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 would strongly encourage you to apply - especially if the reason you are the best candidate isn't exactly as we describe it 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 accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
Notice for California Applicants: Please see our California Applicant Privacy Notice 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 absence of an executed search agreement will not obligate Acadia in any way with the 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.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity
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