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默克药厂
Senior Director, Regulatory Advertising and Promotion
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Senior Director, Regulatory Advertising and Promotion

发布于 43 分钟前

高层管理(VP/总经理/CEO)

Boston, Massachusetts, United States
高级经验
全职员工
混合式弹性办公
本科
合规
Compliance
Fda Regulations
Leadership
Regulatory Affairs
Advertising And Promotion
Labeling Strategy
Opdp
Promotional Review

AI 估算 · 127k–190k

Senior regulatory leadership role with disclosed salary range; reflects high-level expertise and industry standards.

职位详情

关于这个职位

This senior leadership role is responsible for overseeing FDA regulatory compliance for promotional materials in the pharmaceutical industry. You will lead promotional review processes, interact with FDA, and shape regulatory strategies. It requires deep regulatory expertise and strong leadership skills.

最低要求

Bachelor’s degree in science or health related discipline. Advanced degree (PhD, MD, MS, PharmD) highly preferred.

Minimum 10 or more years of pharmaceutical industry or related experience with an emphasis in regulatory or scientific disciplines, with a minimum of seven years of direct experience as the primary reviewer of advertising and promotional materials.
Demonstrated in-depth expertise in FDA regulations governing promotion development, implementation, and promotional review processes, with the ability to shape organizational interpretation and application.
Comprehensive understanding of the clinical development lifecycle, regulatory policy, labeling strategy, and FDA approval processes, applied to inform and guide cross-functional strategic decisions.
Proven ability to lead and resolve highly complex promotional regulatory challenges, driving innovative, compliant solutions across products and therapeutic areas.
Exceptional diplomacy, influence, and negotiation skills, recognized for building consensus and effectively engaging senior stakeholders; demonstrated strategic and analytical leadership in shaping business and regulatory outcomes.

工作职责

Provide cross-functional leadership and representation for Regulatory Affairs on Promotional Review Committees, ensuring U.S. promotional materials are compliant with regulatory requirements while shaping and aligning with overarching corporate and portfolio strategies.

Serve as the senior strategic liaison to FDA promotional review divisions (OPDP and APLB), overseeing high-impact interactions, guiding complex regulatory negotiations, and ensuring consistency and quality in correspondence and advisory submissions.
Define and shape innovative, compliant regulatory strategies and solutions for highly complex and business-critical promotional concepts, enabling enterprise objectives while proactively mitigating regulatory risk across the portfolio.
Lead the oversight and evaluation and positioning of product claims for assets in development, ensuring scientifically robust, compliant messaging and guiding the development of Important Safety Information (ISI) and Brief Summary documents.
Establish and advance the strategic framework for advertising and promotion processes, standards, and SOPs, driving continuous improvement, governance, and operational excellence across the organization.
Lead enterprise interpretation of evolving regulatory trends, guidance, and enforcement activities, and proactively shape organizational strategy by advising senior Regulatory Affairs leadership, review committees, and cross-functional stakeholders on implications for business decisions and compliance.
Identify and provide solutions during labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion.
Oversee and provide direction on regulatory communications, including responses to FDA action letters and high-visibility interactions with OPDP and APLB.
Champion and oversee department-wide capability building, including the strategy, design, and execution of training programs to strengthen organizational expertise and compliance awareness in promotional regulations.
Serve as a key strategic leader across the organization, influencing senior stakeholders across Marketing, Legal, Medical, and Regulatory functions to enable compliant, effective, and business-aligned promotional execution.
Provide leadership oversight for internal audits and CAPAs in partnership with Quality, ensuring strong governance, regulatory alignment, and continuous improvement in compliance practices.
Is seen as a leader and is sought out by peers. Creates capacity to provide support to team members. Proactively seeks opportunities to take on more complex projects and provide promotional regulatory training and coaching to team members. Mentors new hires.
Influence and drive alignment with senior commercial and functional leadership, building consensus and shaping decisions to balance business objectives with regulatory requirements.

优先资格

Experienced leading or supporting drug promotion and product launches is preferred.

Comprehensive understanding of the pharmaceutical industry Regulatory Affairs landscape prescription drugs and labeling considerations.
Demonstrated ability to lead and foster a culture of continuous learning and process improvement across the organization.

AI 洞察

优缺点分析

优点

  • Key strategic role in a top-tier pharmaceutical company, influencing promotional regulatory landscape.
  • Attractive compensation and benefits, including base pay range and performance-based bonuses.
  • High visibility with FDA and senior leadership, providing significant professional credibility.
  • Opportunity to shape innovative compliance strategies and mentor teams.
  • High responsibility and pressure to ensure regulatory compliance, with risk of penalties for non-compliance.
  • Complex stakeholder management across multiple functions and global teams.
  • Requires continuous learning to stay updated with evolving FDA guidance and regulatory trends.
  • This role suits experienced regulatory professionals with deep promotion review expertise and strong leadership capabilities, who thrive in high-stakes, strategic environments.

缺点 / 挑战

暂无明显挑战项

角色解读

  • This is a senior leadership role, with potential to advance to Vice President or Head of Regulatory Affairs within the organization.
  • Opportunities to expand scope to global regulatory leadership or broader compliance functions.
  • The role offers visibility and influence at enterprise level, positioning for executive leadership roles in the pharmaceutical industry.
  • Lead the strategic regulatory oversight of U.S. promotional materials, ensuring compliance with FDA regulations and internal policies.
  • Chair and participate in Promotional Review Committees, guiding cross-functional teams to approve compliant promotional content.
  • Serve as the senior liaison to FDA divisions (OPDP/APLB) for complex regulatory negotiations and high-visibility communications.
  • Develop and implement regulatory strategies for product claims, labeling, and promotional processes across the portfolio.
  • Deep expertise in FDA regulations governing pharmaceutical promotion, including OPDP/APLB guidance.
  • Strong leadership and influence skills to align senior stakeholders across legal, marketing, and regulatory functions.
  • Comprehensive understanding of clinical development, labeling, and regulatory approval processes.
  • Excellent negotiation and communication skills for FDA interactions and cross-functional decision-making.

申请策略

  • Tailor your resume to explicitly address each minimum qualification, using metrics and outcome-focused achievements.
  • Research EMD Serono’s therapeutic areas (Oncology, Neurology, Fertility) and align your experience with their portfolio.
  • Highlight significant experience in regulatory advertising and promotion review, specifying years as primary reviewer.
  • Showcase leadership in cross-functional teams and FDA interactions, with concrete examples of negotiations.
  • Emphasize understanding of clinical development and labeling strategy, with examples of successful promotional claims positioning.
  • Include any experience with drug launches or complex portfolio management.
  • Deepen knowledge of FDA’s OPDP and APLB operations and recent enforcement trends.
  • Enhance strategic communication and negotiation skills for senior-level engagement.

面试指南

  • Use the STAR method (Situation, Task, Action, Result) to provide structured and concise examples.
  • Emphasize your strategic role, collaboration with stakeholders, and the impact of your decisions on business outcomes.
  • Highlight your ability to interpret regulations and translate them into actionable compliant strategies.
  • How have you navigated complex FDA negotiations regarding promotional materials?
  • Describe a time you led a Promotional Review Committee to approve a challenging piece of promotion.
  • How do you stay current with evolving FDA guidance on advertising and promotion?
  • How would you balance business objectives with regulatory compliance in a promotional strategy?
  • Have you been involved in product launches? What regulatory challenges did you address?

职位点评

75
综合评分

High-compensation senior regulatory leadership role in a stable pharmaceutical company, with hybrid work and meaningful social impact.

从薪资福利、成长空间、工作节奏和岗位方向综合评估，方便横向比较。

更适合这类人
This role is best suited for experienced regulatory professionals who prioritize high compensation and career prestige over rapid upward mobility in a stable, purpose-driven industry.
表现最好
薪资福利
相对薄弱
成长发展
薪资福利85
成长发展65
工作生活70
使命价值80

薪资福利

85较高

This role offers a highly competitive base salary range and comprehensive benefits, though actual compensation may vary based on location and experience.

薪资信号偏高 (126K-189K/月)
福利待遇health insurance、paid time off (PTO)、retirement contributions、performance-based bonuses

成长发展

65中等

While the role provides opportunities for career advancement and continuous learning, it is already a senior position with limited further upward mobility within the same domain.

技术前沿非技术岗（不适用）
成长机会personal development、career advancement、continuous learning
业务类型ambiguous

工作生活

70中等

The hybrid work model (3 days in office) provides some flexibility, and the location in Boston Seaport is convenient. However, the senior role may demand significant time and travel (up to 20%).

工作模式混合式弹性办公
办公地点市区核心地段
加班情况未提及（无法判断）
工作生活平衡flexible working culture

使命价值

80较高

Working in the pharmaceutical industry to help create, improve, and prolong lives provides a strong sense of purpose and positive social impact.

行业发展稳定成熟行业
社会影响正向社会影响力较高
使命信号help create, improve and prolong lives、for patients
创新程度稳健跟随主流

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