Please note that this position is based in Princeton, NJ. Acadia’s hybrid model requires this role to work in our office three days per week on average.
The Manager of Regulatory Affairs (RA) Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing input on labeling requirements and strategic guidance during label development, assisting the Head of RA Labeling with cross functional labeling discussions with Labeling Management Team (LMT) and Executive Labeling Committee (ELC) as appropriate, and label-related Health Authority negotiations. They will oversee end-to-end labeling process including lifecycle management of labeling and artwork for all Acadia products both in development and on market. This will include management of internal global Company Core Data Sheet (CCDS) process, labeling SOP, initial draft label development, managing label review and finalization process, and managing post-approval labeling updates.
Primary Responsibilities
- Support with developing draft labeling text (e.g. USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management
- Support implementation of a labelling review and approval process, including documentation of label history, LMT/ELC decisions, and exceptions from CCDS to facilitate end to end global labeling process
- Ensure labeling strategy is aligned with overall regulatory and program strategy by working collaboratively with key internal stakeholders, including but not limited to Regulatory Affairs, Clinical Research, Drug Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, and Supply Chain
- Assist with cross-functional labeling and related forums and meetings, such as LMT to support draft Label development
- Interact with Regulatory Strategy Lead to ensure timely submission and implementation of global labeling requirements that are consistent with the company’s position in the CCDS and in compliance with local labeling requirements
- Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities
- Support the implementation and maintenance of policies and procedures for the creation and management of labeling and communicate to appropriate stake holders
- Manage the review, QC and approval process for all product labeling components and CCDS
- Support the development of labeling negotiations strategic plans and assist with implementing feedback from health-authority on draft labeling..
Education and Experience
Bachelor degree in a scientific discipline or related field; advanced degree (e.g., PharmD) preferred. Targeting 2 years of Regulatory Affairs experience. A thorough understanding of global regulatory labeling requirements and strategic labeling planning preferred.
Key Skills:
- Must have strong knowledge labeling content development through regulatory submission and review process, Health Authority negotiations resulting in product approval
- Knowledge of US and international regulations as they apply to pharmaceutical drug development
- Strong writing skills; able to process scientific data and effectively summarize into the appropriate detail for labeling content.
- Experience in organizational management, including matrix management of senior professionals and higher- level project teams.
- Ability to work in a cross-functional team environment and a flexible team-oriented
- Demonstrated problem solving abilities and conflict resolution
- Excellent verbal and written organizational and communication
- Skilled at negotiating with business partners or management regarding matters of significance to the organization.
- Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational 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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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 [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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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.
