Regulatory operations

As Senior Vice President, Regulatory Operations (Freelance), you will provide strategic regulatory expertise to support an internal team preparing for an upcoming product launch. This non-client-facing role will focus on refining FDA submission materials and timelines, ensuring submissions and overall process is compliant , and advising on regulatory best practices to minimize risk and maximize launch readiness.

This role requires a seasoned regulatory expert with extensive experience in pharmaceutical marketing launches, specifically with deep knowledge of FDA submission processes . This role in particular would focus on APLB (Office of Prescription Drug Promotion) and OPDP (Office of Prescription Drug Promotion), as well as the complexities of accelerated approvals.

As a trusted advisor, you will provide guidance, tools, and actionable recommendations to ensure the team is equipped to execute the launch with confidence and precision.

Key Responsibilities:

• Provide high-level recommendations to optimize the team’s day-to-day operations, project management workflows, planning tools, and detailed launch timelines.

• Act as the team’s primary resource for questions on regulatory standards, submission best practices, and risk mitigation strategies.

• Establish repeatable best practices, SOPs (Standard Operating Procedures), and templates to streamline future product launches and improve collaboration with medical, legal, and regulatory review teams.

• Advise the team on the agency’s role within the submission process, providing actionable recommendations to strengthen collaboration with clients and partner agencies.

• Support submission readiness by identifying potential gaps or risks, creating contingencies to minimize resubmission delays or regulatory approval challenges.

• Provide expert guidance on navigating accelerated approval timelines, ensuring compliance with FDA regulations while balancing the demands of creative and impactful communication strategies.

• Serve as a strategic partner to ensure regulatory-first thinking is embedded without hindering creativity, enabling the development of compliant and powerful launch campaigns.

What You’ll Need to Succeed:

Experience and Credentials:

• 10+ years of experience in regulatory affairs, pharmaceutical marketing, or relevant communications roles, with specific expertise in FDA submission processes (APLB and OPDP).

• Advanced degree in a life sciences field (MSc, PhD, or PharmD preferred) or equivalent professional experience.

• Strong familiarity with FDA marketing regulations, enforcement trends, and best practices for rare disease products or niche therapeutic areas.

Key Skills and Competencies:

• Regulatory Educator: Proven ability to train internal teams by translating complex regulatory requirements into clear, actionable guidance.

• PRC Review Leader: Hands-on experience conducting mock PRC reviews, with a keen ability to identify risks, refine materials, and improve compliance outcomes.

• Detail-Oriented Strategist: Highly skilled in regulatory strategy development, ensuring submission materials are precise and risk-free.

• Collaborative Partner: A team player who fosters a collaborative and supportive environment, providing expert advice in a non-client-facing capacity.

• Problem Solver: Capable of proactively identifying risks, addressing compliance gaps, and delivering practical, actionable solutions to overcome challenges.

The Weber Shandwick Collective recognizes that your health and wellbeing are a priority. This is why we offer a full suite of benefits including:

• Medical
• Dental
• Vision
• 401k (with employer match)
• Tuition Reimbursement
• Juice Money - $60 monthly reimbursement to be used towards purchases that nourish your health, mind, body, and soul
• MyDays - Flexible holiday schedules
• Short-Term Disability
• Paid Employee Family Leave
• Family Building Benefit

NYC Salary range: $125.0 - $150.0

Where an employee or prospective employee is paid within this range will depend on, among other factors, actual ranges for current/former employees in the subject position; market considerations; budgetary considerations; tenure and standing with the company (applicable to current employees); as well as the employee’s/applicant’s background, pertinent experience, and qualifications.

Weber Shandwick is proud to be an Equal Opportunity/Affirmative Action employer. Weber Shandwick recruits qualified applicants without regard to race, color, religion, gender, age, ethnic or national origin, protected veteran status, physical or mental disability, sexual orientation, gender identity, marital status or citizenship status.

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