Associate Director, Regulatory Affairs, Advertising and Promotion at Acadia Pharmaceuticals

Waltham, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

BiopharmaceuticalIndustries

Requirements

BA/BS degree in a scientific discipline; advanced scientific degree preferred
Minimum 7+ years of Pharmaceutical/Biotech industry experience in drug advertising and promotion review
4+ years’ experience as the primary Regulatory representative in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations, and guidance documents, including direct experience communicating with OPDP
Significant Subpart H and/or Subpart E submission experience
Excellent verbal and written communication skills
Strong attention to detail with the ability to check documents for accuracy and consistency
Proficiency using promotional review software, such as Veeva Promomats
Ability to navigate complex regulatory framework while remaining solutions-oriented to address corporate objectives
Knowledge of clinical study design and statistical analyses in the assessment of promotional claims
Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders
Consistently meets deadlines without compromise to work

Responsibilities

Reviewing and approving the regulatory content of materials created for product promotion, corporate, and other non-promotional materials to assess for compliance with applicable regulations, guidance documents, and internal policies/best practices
Represent the commercial regulatory perspective at the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Legal/Compliance
Lead discussions in review committees, collaborating with stakeholders from Legal, Medical, and commercial teams to reach consensus on promotional materials
Serve as internal expert on FDA regulations, guidance and enforcement trends governing the promotion of Madrigal products
Assume a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities
Manage interaction with the Office of Prescription Drug Promotion (OPDP) including response to regulatory inquiries, preparation of submissions for advisory comments, and timely preparation and submission of promotional materials under cover of FDA Form 2253
Ensuring stakeholder awareness on planned and approved label updates and how they impact Promotional and Medical materials; provide key stakeholders with guidance on implementation of ISI and labels in a timely manner
Align and maintain effective communication channels with Medical, Marketing, Regulatory, Legal, and corporate counterparts
Provide training on FDA regulations for advertising and promotion to employees and agents of Madrigal
Participate in company working groups on advertising and promotion standards and guidelines
Assist on the development strategies of US labeling to ensure support for anticipated promotional messages and claims
In the absence of the Senior Director, responsible for day-to-day operations

Skills

Regulatory Affairs

FDA Regulations

Promotional Review

OPDP Interactions

FDA Form 2253

Compliance Review

Promotional Materials

Cross-functional Collaboration

Regulatory Strategy

Acadia Pharmaceuticals

Develops therapies for neurological disorders

About Acadia Pharmaceuticals

Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia differentiates itself by targeting areas with significant unmet medical needs, ensuring that their products address critical health challenges. Their goal is to improve the quality of life for patients suffering from these disorders while also promoting diversity, equity, and inclusion within their operations.

Dallas, TexasHeadquarters

1993Year Founded

$813.4MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Paid Vacation

Paid Holidays

Paid Sick Leave

Paid Parental Leave

Tuition Reimbursement

Risks

Increased competition in CNS drug market may impact Acadia's market share.

Potential clinical trial delays could affect drug approval timelines.

Dependence on partnerships poses risks if collaborations face challenges or dissolve.

Differentiation

Acadia focuses on CNS disorders with unmet medical needs, like Parkinson's and Rett syndrome.

The company has a strong R&D foundation, developing innovative small molecule drugs.

Acadia's strategic partnerships enhance its research capabilities and market reach.

Upsides

Acadia's collaboration with Saniona expands its portfolio with SAN711 for neurological disorders.

Health Canada's approval of Daybue boosts Acadia's presence in the Canadian market.

The rise of personalized medicine aligns with Acadia's targeted therapy approach.

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