January 9th, 2023 Regulatory Affairs

Regulatory Affairs Advertising/Promotion Future Opportunities

San Diego, California, United States

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Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.

Acadia Pharmaceuticals is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 years, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. If you’re looking for a company where you’ll make a difference every day and work on a team where authenticity, equity, and innovation are valued—Acadia is the place for you.

At Acadia, we developed the first and only therapy (NUPLAZID®) approved for hallucinations & delusions associated with Parkinson’s disease psychosis. We have our headquarters in San Diego along with offices in Princeton, New Jersey and Basel, Switzerland. Our late-stage development efforts are focused on central nervous system disorders and Rett syndrome, a rare disease. As we move forward, we are exploring novel approaches to pain management, cognition and neuropsychiatric symptoms in central nervous system disorders.

Although this is not a current opening, Acadia will be looking for individuals who are a strong fit within our Regulatory Affairs Team. Please submit your resume and we will be in touch if we have any upcoming roles that fit your skills and interests! 

 

 

Position Summary

The Regulatory Affairs Advertising and Promotion Director is responsible for reviewing internal and external communications including advertising and promotional activities as well as facilitation of labeling development, maintenance, and distribution for all Acadia products! This role coordinates the development and implementation of regulatory strategies for promotion and advertising plans and provides Regulatory leadership and mentorship in the Medical, Legal, and Regulatory Review process to support approval and dissemination of marketed products and disease state promotional material.

Primary Responsibilities

  • Performs document-level publishing tasks including formatting, bookmarking, and QC (publishing-focused)
  • Independently publishes routine submissions to Acadia INDs and NDAs including but not limited to: general correspondence, protocol amendments, information amendments, and annual reports/PADERs/DULRs
  • Works with senior regulatory operations team members, submission managers, and other team members to publish and coordinate QC of large submissions including but not limited to: original NDAs and supplements, original INDs and major information amendments, responses to health authority questions

Qualifications

  • Desired 5+ years experience in Regulatory Affairs or related function
  • Prior experience working in Advertising, Promotion, and Labeling activities

Additional roles within our Regulatory Affairs department with potential future opportunities include:

  • Regulatory Affairs CMC
  • Regulatory Affairs Operations
  • Regulatory Affairs Strategist

 

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.

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