Director Regulatory CMC
The Director of Regulatory CMC is responsible for the regulatory aspects of Chemistry Manufacturing Controls (CMC) activities supporting the development and commercialization of small molecules therapeutics (including peptides). Leads 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 with external entities, including acting as a point of contact with global regulatory agencies as needed. Serves as a resource to the CMC team members for the regulatory requirements, processes, and logistics to conduct global drug development and commercial activities.
- Manages the CMC regulatory affairs activities for compounds in development in line with US, European, International Conference on Harmonization (ICH), and other applicable requirements
- Coordinates with Regulatory, Quality Assurance, Pharmaceutical Development and other functional areas to develop and implement CMC regulatory strategy
- Contributes as a key regulatory representative with external parties for CMC development activities
- Acts as a point of contact with regulatory agencies for CMC development activities
- Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks
- Manages the timely preparation, review and submission of documents to regulatory authorities including FDA, European Medicines Agency (EMA) and other national authorities, to support the conduct of clinical trials and marketing applications
- 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
- Bachelor’s degree in a life science or an equivalent combination of relevant education and applicable job experience may be considered. An equivalent combination of relevant education and applicable job experience may be considered
- A minimum of 10 years progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development with 6 years in a management role
- Knowledge and understanding of US as well as global regulatory regulations and guidelines
- Previous experience in the preparation and submission of the CMC components of Investigational New Drug (IND)/Clinical Trial Authorization (CTA) filings as well as New Drug Application (NDA)/supplemental NDAs/Marketing Authorization Applications (MAAs)
- 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 business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization
- Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals
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. Employee must occasionally lift and/or move up to 15 pounds.
What we offer you:
- 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: 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 [email protected] 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 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.