Director, Regulatory Affairs Lead

4 weeks ago

Parsippany, New Jersey, United States Ferring Pharmaceuticals Inc. Full time
Job Title: Director, Regulatory Affairs Lead

Job Summary:

We are seeking a highly skilled Director, Regulatory Affairs Lead to join our team at Ferring Pharmaceuticals Inc. in Parsippany, New Jersey. As a key member of our Regulatory Affairs department, you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling, and submission operations within US RA.

Key Responsibilities:

* Manage the US RA Ad Promo, submission operations, labeling, and compliance group staff, including objective setting and career development activities and motivate line reports to achieve shared and individual goals.

* Serve as subject matter expert and provide direction and regulatory expertise for Ferring's promotional materials, medical, and payer communications.

* Serve as primary contact with the FDA (OPDP/APLB), including responding to agency inquiries and managing company requests for advisory review of advertising and promotional material.

* Reviews and approves Form FDA-2253 submissions as needed.

* Support the US commercial and brand teams, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics.

* Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are aligned with U.S. promotional regulations, corporate standards, and policies and business objectives.

* Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks.

* Ensure consistent application of FDA advertising and promotion regulations, and guidances across product portfolios and compliance with Ferring policies and procedures whilst remaining consistent with labeling.

* Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters, and policy issues and trends affecting the pharmaceutical/biologics industry. Communicate significant changes in FDA perspective to relevant stakeholders.

* Contribute to promotional and medical review and standards development; contributes to local or global process improvement initiatives for activities related to regulatory advertising and promotion.

Requirements:

* Requires a BA/BS degree; advanced degree preferred (PharmD, PhD, MS, MBA, JD).

* 10+ years of industry experience including 5+ years of advertising promotion experience.

* At least 1-year experience as a line manager.

* Strong knowledge of PhRMA guidelines, FTC guidelines, and applicable US regulations and guidance and their interpretation relevant to prescription drug advertising, promotion, and labeling.

* Experience with US labeling requirements and strong knowledge of the drug development process, including development of labeling to achieve desired promotional claims.

* Excellent verbal and written communication skills.

* Attention to detail and ability to manage multiple priorities simultaneously.

* Strong interpersonal skills with ability to demonstrate strategic and analytical thinking.

* Demonstrated ability to negotiate and influence others effectively.

* Demonstrates and proactively advocates working together in the spirit of openness, honesty, and transparency that encourages engagement, collaboration, respectful interactions, and trust.

About Ferring:

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support, and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our 'People First' philosophy.

Our Compensation and Benefits:

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $174,000 to $254,150, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education, and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

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