Executive Director - Regulatory Advertising and Promotions

November 1

Apply Now

Receive Emails with Similar Jobs

PTC Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

Orphan and Ultra-orphan Disorders • Oncology • Anti-infectives

501 - 1000

Description

• Provides strategic advice and tactical management for regulatory advertising and promotions • Leads negotiations with FDA’s OPDP and APLB for assigned products • Ensures regulatory compliance while managing business risks • Collaborates with internal departments and external resources on promotional materials • Reviews and approves advertising and promotional materials for compliance with FDA regulations • Develops and maintains regulatory procedures for advertising and promotional materials • Monitors, interprets and communicates updates on FDA guidance to internal stakeholders • Supports emerging department business needs as determined by regulatory leadership

Requirements

• Bachelor’s degree in a scientific or technical discipline • Minimum of 10 years’ experience in Regulatory Affairs Ad/Promo • Experience managing direct reports • Product Launch experience • Rare disease, Oncology and/or other relevant therapeutic area experience is desirable • Advanced knowledge of FDA guidelines and regulations • Outstanding communication skills • Hands-on experience in leading promotional OPDP submissions • Familiarity with Veeva PromoMats and RIM • Ability to engage, influence and navigate senior stakeholders • Strong interpersonal skills • Ability to work independently and collaboratively in a fast-paced environment • Analytical thinker with excellent problem-solving skills • Excellent planning, organization and time management skills

Benefits

• Short- and long-term incentives • Medical, dental, vision, and retirement savings plans