Director, Regulatory Affairs (US)

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 of the whole US portfolio. 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 to ensure the maintenance, compliance, possible extension program and acquisition, and provide a support for local process notably on PRC review.

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

Regulatory Strategy

• Ensure an efficient and accurate reporting to global level
• Develop, recommend 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
• Continue to develop a strong relationship with local authorities

Regulatory Advertising, Promotion and Labelling:

• Leads process to update labeling components including managing meetings, timelines, and review process.
• Ensures labeling is consistent with core company position.
• Responsible for regulatory product/promotional review for drug and medical device products and contributes to promotional review committee for all company products and medical device
• Serve as the company subject matter expert for regulatory review of advertising and promotion materials, providing direction and regulatory expertise for promotional materials
• Participate to continuous improvement of review process and educate the local regulatory team to reinforce our internal capacity
• Ensures regulatory requirements are met for promotional materials submissions and labeling submissions (annotations, Structured Product Labeling (SPL) documents)

 Compliance:

• Assures product compliance with applicable regulations throughout the lifecycle of the product

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

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 applicable U.S FDA regulations and guidance and their interpretation relevant to prescription drug advertising, promotion and labelling and PhRMA guidelines
• Excellent interpersonal and communication abilities, including verbal, written, teamwork and leadership skills  
• A proven leadership and strong emotional intelligence
• 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)

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.