About Acadia Pharmaceuticals
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.
Position Summary
The Manager, Regulatory Affairs is responsible for implementing global regulatory strategies and submissions for product(s) in the assigned asset teams. This role will assist senior Regulatory Affairs department staff in the development of regulatory strategy and compilation of documentation to support US and global regulatory submissions for clinical trials and marketing applications.
Primary Responsibilities
- Oversee and manage all phase of regulatory submissions
- Plan and prepare complex regulatory documents required for health authority submission and/or approval with minimal supervision, ensuring all documentation meets regulatory standards and guidelines
- With senior level instruction and oversight, contribute to comprehensive regulatory strategic plans that align with the company’s strategic objectives
- Manage incoming correspondence from regulatory authorities, coordinating with cross-functional teams and subject matter experts providing complete and timely responses to requests for information; may serve as primary point of contact for regulatory authorities on assigned programs depending on experience
- Maintain subject matter expert knowledge on regulations, guidance, and regulatory intelligence utilizing subscription-based services and public databases
- Coordinate the posting of clinical trial information in public registries to ensure transparency and compliance with regulatory requirements
- Execute team, group, and/or project objectives to ensure they align with regulatory strategy and corporate goals
- Maintain clear and effective communication within the regulatory affairs function and across other departments, particularly at the project team level
- Participate in professional associations, industry forums, and trade groups to stay current on regulatory intelligence, applying this knowledge to assigned programs
- Work with growing independence under the direction of a supervisor, demonstrating initiative and leadership in regulatory activities
Education/Experience/Skills
- Bachelor’s degree in a life science or related field required, advanced degree is desired. Targeting 5 years progressively responsible experience. An equivalent combination of relevant education and applicable job experience may be considered.
- Must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations.
- Specific requirements include but are not limited to:
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- At least 5 years of experience in US and global Regulatory Affairs in the pharmaceutical/ biotechnology industry
- Bachelor degree in a scientific discipline, advance degree preferred
- Strong knowledge of US regulations and requirements; exposure to EU regulations desirable
- Strong business acumen and demonstrated ability to make sound decisions that contribute positively to the business
- Strong team leader that has customer service approach and is solution oriented
- Excellent attention to detail, written and verbal communication, and strong influencing and negotiating skills
- Ability to prioritize and handle multiple projects simultaneously
- Business travel ~10% as required
Scope
Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors ad an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization
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. Employee must occasionally lift and/or move up to 15 pounds.
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.
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 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 accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
Notice for California Applicants: Please see our California Applicant Privacy Notice 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 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.