SVP, Regulatory Operations - Freelance

AsSenior Vice President, Regulatory Operations (Freelance),you will providestrategic regulatory expertiseto support an internal team preparing for an upcoming product launch. Thisnon-client-facing rolewill focus onrefining FDA submission materials and timelines, ensuringsubmissions 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)andOPDP (Office of Prescription Drug Promotion), as well as the complexities ofaccelerated approvals.

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

Key Responsibilities:

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

• Act as the team'sprimary resourcefor questions on regulatory standards, submission best practices, and risk mitigation strategies.

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

• Advise the team on theagency's rolewithin 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 minimizeresubmission delaysor regulatory approval challenges.

• Provide expert guidance on navigatingaccelerated approval timelines, ensuring compliance with FDA regulationswhile balancing the demands of creative and impactful communication strategies.

• Serve as a strategic partner to ensureregulatory-first thinkingis 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 experiencein 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 withFDA marketing regulations, enforcement trends, and best practices forrare disease productsor niche therapeutic areas.

Key Skills and Competencies:

• Regulatory Educator:Proven ability totrain internal teamsby translating complex regulatory requirements into clear, actionable guidance.

• PRC Review Leader:Hands-on experience conductingmock 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 anon-client-facingcapacity.

• Problem Solver:Capable ofproactively 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: $125.00 - $150.00

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.