Associate Director, Regulatory Affairs CMC at Acadia Pharmaceuticals Inc.

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

199600.0

Posted On

15 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, CMC Strategy, Clinical Trials, Marketing Approval, Cross-Functional Teamwork, Interpersonal Skills, Attention To Detail, Organizational Skills, Documentation, Regulatory Compliance, Manufacturing Processes, Risk Assessment, Communication, Negotiation, Project Management, Scientific Knowledge

Industry

Pharmaceutical Manufacturing

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 or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. Position 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 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 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. 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.

Responsibilities

The Associate Director, Regulatory CMC, is responsible for developing and implementing global regulatory CMC strategies for small molecule therapeutics. This includes coordinating regulatory activities for clinical trials and marketing approvals, as well as providing guidance on regulatory requirements to the CMC team.