Manager, Regulatory Affairs

Job Requisition ID: 32387

Department: REG

Category: Corporate - MA

Location:

US Field

Date: 14 Nov 2024

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

This individual is expected to work closely with the Regulatory Affairs team and cross functional teams as required. This individual will report into our Associate Director of Regulatory Affairs, offering a range of support as required with a focus on pharmaceutical promotional material, labeling, and product compliance.

This individual will also have the occasional travel to our Hattiesburg, MS location and other travel as needed by the company. This individual will have a focus on our recently acquired product RSDL.

As Regulatory Affairs Manager, your responsibilities will include:

Promotional materials/Labeling:

• Contributes regulatory expertise for the development and submission of promotional materials and labeling components.
• Provides regulatory review for promotional material and labeling 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
• Evaluates and communicates the impact of new regulations on company products.
• Ensures consistency and adherence to regulations for regulatory submissions.
• Updates internal company procedures to align with current regulations
  
  

Other

• Acts as a regulatory expert and participates as an active team member of multi-disciplinary teams
• Assists in regulatory FDA interactions and meetings
• Coordinates IND and NDA/BLA submissions including amendments, supplements, variations, meeting requests, briefing packages, annual reports, IR/RFI responses, orphan drug designation requests
• Updates internal regulatory database (ie, Veeva Vault)
• 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:

• Bachelors Degree in Life Sciences or relevant field preferred
• Pharmaceutical experience highly preferred
• 5+ years of experience in Pharma or Regulatory
• Previous experience in medical devices is a plus
• Excellent verbal and written communication and interpersonal skills
  
  

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.