Director, Regulatory Affairs, US at SERB Pharmaceuticals

Come and Save Lives with Us!

SERB Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. We have over 470 employees in 16 countries and a group revenue in excess of €350m.

Our portfolio 80+ rescue medicines make a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.

Our Purpose is supported by our 4 key values:

• We make patients our priority
• We act with integrity and accountability
• We work together as one team
• We look for better ways forward

Broad Overview

The Director of Regulatory Affairs (U.S.) will be responsible for leading the regulatory strategy and overseeing all regulatory activities for the company's U.S. operations. This individual will lead US regulatory affairs professionals and work closely with the Global Regulatory Affairs team and cross functionally teams. This individual will report into our Head of Global Regulatory Affairs offering a range of support as required with a focus on Regulatory Advertising, Promotion and labeling activities.

In this role, the individual will drive regulatory strategies and labelling product compliance initiatives to support FDA approvals and maintain regulatory compliance across our product portfolio.

As the Director of Regulatory Affairs, your responsibilities will include:

Regulatory Strategy

• Develop and implement the U.S. regulatory strategy aligned with the company’s business goals and objectives
• Lead and execute U.S. regulatory activities, ensuring compliance for product marketing
• Serve as key regulatory team leader for business development activities (due diligence)
• Provide regulatory expertise and guidance to senior management and cross-functional teams.
• Lead the preparation and submission of regulatory filings (e.g., 510(k), PMA, NDA, BLA) for new products, product modifications, and renewals
• Advise on regulatory risks and offer strategies for risk mitigation throughout the product development lifecycle

Regulatory Advertising, Promotion and Labelling:

• Serve as the company subject matter expert for regulatory review of advertising and promotion materials and provide regulatory leadership to the respective cross-functional teams, providing direction and regulatory expertise for promotional materials
• Contributes to promotional review committee for all company products and medical device
• Responsible for regulatory product/promotional review for drug and medical device products
• Provides regulatory review for labelling submissions
• Ensures regulatory requirements are met for promotional materials submissions and labeling submissions (annotations, Structured Product Labeling (SPL) documents).
• Leads process to update PI or labeling components including managing meetings, timelines, and review process.
• Ensures labeling is consistent with core company position.

Compliance:

• Assures product compliance with applicable regulations throughout the lifecycle of the product
• Identifies and communicates the impact of new regulations on company products.
• Develops and maintains current regulatory knowledge in the areas of advertising and promotion and CCDS and advises management of significant developments
• Maintains regulatory and technical sections of CTD filings to ensure compliance with global filings in line with company scientific data
• Ensures consistency and adherence to U.S. regulations for regulatory submissions
• Responsible for revising, integrating and aligning U.S. regulatory SOPs with global regulatory SOPs
• Updates internal company procedures to align with current regulations

Team Leadership and Development:

• Lead, mentor, and develop a team of regulatory affairs professionals
• Foster a culture of continuous learning, compliance, and excellence within the Regulatory Affairs department
• Provide training to staff on regulatory requirements, guidelines, and company procedures

Other

• Acts as a regulatory expert and participates as an active team member of multi-disciplinary teams
• Manage meetings and interactions with the FDA, including pre-IND, pre-NDA, and other advisory meetings
• Coordinates IND and NDA/BLA submissions including amendments, supplements, variations, meeting requests, briefing packages, annual reports, IR/RFI responses, orphan drug designation request
• Supports budgeting and forecasting for US team
• Other duties as assigned by Line Manager

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

To be successful in this role, you should demonstrate:

• Strong knowledge of PhRMA guidelines, and applicable U.S FDA regulations and guidance and their interpretation relevant to prescription drug advertising, promotion and labelling
• Excellent interpersonal and communication abilities, including verbal, written, teamwork and leadership skills
• 10+ years of pharmaceutical company experience including 5+ years of advertising promotion experience
• Bachelor's Degree in Life Sciences or relevant field; advanced degree preferred (PharmD, PhD, MS, MBA, JD)
• At least 1-year experience as a line manager
• Previous experience in medical devices is a plus

Company Benefits:

• Vacation, Sick and Personal Time
• Medical, Dental, Vision and other Voluntary benefits
• Paid Parental Leave
• Tuition Assistance
• Discretionary Bonus Plan
• Competitive 401(k)

EEO Disclaimer

SERB is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any protected characteristic protected by federal, state, or local laws. If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment requirements, or otherwise participating in the employee selection process, please direct your inquiries to the HR Department.