Senior Manager, Regulatory Affairs Labeling

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Posted : 16-May-24

Location : multiple,

Type : Full Time

Categories :

Quality / Risk Management Regulatory Compliance Submission & Registration US Regulatory Affairs

Salary Details :

1099 and W2 options available

Preferred Education :

4 Year Degree

Additional Information :

2 openings available.

Internal Number : GLLABELING

This is an exciting contract role for a regulatory professional with expertise in labeling. We are looking for someone who is proactive and dynamic, with excellent communication skills and a can-do attitude.

The role can be fully remote, or hybrid working on-site with this global biopharma company.

The key responsibilities of this role are as follows :

• Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory Strategy by providing labeling expertise (labeling regulations, internal processes and competitor analyses) for CCDS, USPI and SmPC (Centralized / Mutual Recognition / Decentralized Procedure) for medium to low complex projects in the Lifecycle Management (LCM) projects
• Serves as primary contact for cross-functional Labeling Team, and works as interface for Country Regulatory Managers to support timely and quality submissions globally
• Coordinates labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality
• Ensures effective planning of all cross-functional labeling activities
• Reviews country labels to ensure labeling compliance
• Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities
• Participates in key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals

Educational / Skill Requirements

• Masters of Life Sciences or equivalent, with thorough understanding of scientific principles or Bachelor of Life Sciences with at least 2 years of Labeling / Regulatory Experience
• Good Understanding of Drug Development and Commercialization of prescription medicines
• Ability to understand regulatory implications of product strategy related to labeling development, assessment and management
• Excellent verbal and written communication skills

G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse.

All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.

• Labelling : 2 years (Preferred)
• Regulatory Affairs : 5 years (Preferred)

Create a Job Alert for Similar Jobs About G&L Healthcare Advisors Are you ready to be best in class? At G&L, we use subject matter expertise and decades of experience gained in every aspect of Regulatory Affairs, Quality Assurance and Clinical Development to meet the challenges faced by healthcare companies globally.

From product development and submissions to company-wide change management, we design, implement, and run quality, results-focused outcomes for everyone we work with.

Connections working at G&L Healthcare Advisors https : / / regulatorycareers.raps.org / jobs / 20108432 / senior-manager-regulatory-affairs-labeling