Senior Director Regulatory Affairs
Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.
Provides regulatory leadership and develops regulatory strategies for products in development to support clinical trial application and marketing approvals in the US and internationally, as well as life cycle management of approved products and maintains compliance with applicable regulatory requirements. Supports business development activities, serving as regulatory expert as part of cross-functional diligence teams to assess external assets/opportunities. Acts as a resource to the broader regulatory function, including mentorship of less experienced staff.
- Provides strong regulatory and scientific leadership to the overall development team to ensure that the development plan provides for optimal scientific positioning and highest regulatory probability of success.
- Interprets and applies regulations in the creation of timely and innovative regulatory strategies for US and international markets.
- Represents the regulatory function on cross-functional development teams.
- Plans, prepares, and reviews submissions to regulatory authorities including FDA, EMA and other global health authorities to support the conduct of clinical trials and approval of marketing applications (including but not limited to Investigational New Drug (IND), Clinical Trial Authorization (CTA), New Drug Application (NDA), and Marketing Authorization Application (MAA). Works with regulatory submissions coordinator to develop submission timelines and work with cross-functional teams to planned objectives.
- Serves as the primary point of contact with Regulatory Authorities and develops strong working relationships with counterparts of FDA, EMA, and other regulatory authorities
- Interacts with regulatory agencies, coordinating the preparation and supporting documentation as well as leading meetings and other interactions; maintains correspondence and other records of interaction.
- Manages all maintenance plans for regulatory investigative and marketing applications for assigned projects.
- Acts as regulatory expert for diligence of external assets as part of business development activities.
- Monitors, analyzes, and disseminates intelligence on regulatory matters that may affect ongoing development programs.
- Provides regulatory guidance and/or training to external departments.
- Prepares and revises internal procedures for continuous improvement.
- Manages activities performed by regulatory
- Advanced degree in a life science required, e.g. PhD, PharmD or Master’s degree. An equivalent combination of relevant education and applicable job experience may be considered.
- 10+ years of experience in regulatory affairs management in the pharmaceutical/biotechnology
- Experience in neuroscience drug development a plus
- Global experience required
- Prior experience managing development and submission of NDAs/MAAs and INDs
- Thorough knowledge of US and international regulations as they apply to pharmaceutical and biologic drug development
- Prior experience leading regulatory agency interactions, meetings (including Advisory Committees or Scientific Advise procedures)
- Full lifecycle experience from early development to managing marketed products
- Ability to work in a cross-functional team environment and a flexible team-oriented perspective
- Excellent verbal and written communication skills as well as interpersonal, management, and organizational skills
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.
The salary range for this role is $214,000.00 to $267,500.00. Actual amounts will vary depending on experience, performance, and location. 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.
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
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.