Sr. Manager Labelling

Senior Manager, Global Labeling Compliance

Key Responsibilities:

1. Leadership & Team Management:

• Manage and develop

  a team of labeling specialists, providing direction, mentorship, and performance feedback to foster professional growth.

• Create a collaborative environment

  , guiding cross-functional teams to meet global labeling objectives and deliverables.

• Set clear goals and priorities

  for the labeling team, ensuring alignment with broader Regulatory Affairs and organizational strategies.

2. Labeling Planning & Execution:

• Oversee end-to-end labeling projects

  , from content creation and revisions to final implementation, ensuring on-time, in-full delivery of labeling materials.

• Coordinate across functions

  (e.g., Regulatory Affairs, Quality, Operations, Supply Chain) and regions to manage complex labeling changes and meet international requirements.

• Develop and manage project plans

  , defining timelines, milestones, and resources, and proactively identifying and mitigating potential risks or delays.

3. Compliance & Inspection Readiness:

• Ensure alignment

  with global regulatory requirements and company standards, maintaining consistent inspection readiness across labeling activities.

• Implement effective controls

  for tracking, auditing, and updating labeling content, ensuring accurate and compliant product information.

• Collaborate with Quality Assurance teams

  to address and close any compliance gaps or findings from audits, ensuring ongoing compliance.

4. Stakeholder Management:

• Manage relationships with external vendors

  , such as translation and artwork providers, by setting clear Service Level Agreements (SLAs) and key performance indicators (KPIs) to ensure optimal performance.

• Communicate effectively

  with global teams, regional affiliates, and third-party partners, maintaining transparency and driving successful outcomes across labeling processes.

5. Continuous Improvement & Systems Optimization:

• Identify and implement opportunities

  to enhance labeling workflows and processes, driving efficiencies and cost savings without compromising quality or compliance.

• Leverage technology

  , including Labeling Management Systems, to improve labeling accuracy, data integrity, and cross-functional visibility.

• Champion best practices

  , developing Standard Operating Procedures (SOPs), work instructions, and training materials to ensure quality and compliance in all labeling activities.

Basic Qualifications:

• Doctorate degree

  and

  3 years

  of Pharmaceutical, Regulatory, or Quality Management experience OR

• Master's degree

  and

  8 to 12 years

  of Pharmaceutical, Regulatory, or Quality Management experience OR

• Bachelor's degree

  and

  12 to 14 years

  of Pharmaceutical, Regulatory, or Quality Management experience OR

• Diploma

  and

  16 to 18 years

  of Pharmaceutical, Regulatory, or Quality Management experience.

Preferred Qualifications:

• Proficiency in project management

  and vendor oversight, ideally within a global or matrixed organization.

• Experience with electronic Labeling Management Systems

  , such as

  Veeva Vault

  or similar tools.
• Strong knowledge of

  global regulatory labeling requirements

  , including

  US, EU

  , and

  emerging markets

  .

• Strong analytical skills

  for troubleshooting, process mapping, and implementing continuous improvement initiatives in labeling and compliance processes.

Soft Skills:

• Excellent

  leadership

  , communication, and interpersonal skills.
• Ability to

  prioritize tasks

  in a fast-paced, dynamic environment.

• Problem-solving

  and decision-making skills with a focus on compliance and operational excellence.
• Ability to

  collaborate across multiple teams

  , aligning on global strategies and deliverables.
• Strong

  attention to detail

  and

  commitment to quality

  in all aspects of work.

What We Offer:

• Opportunity to

  lead and shape

  global labeling compliance initiatives in a highly dynamic and innovative environment.
• A collaborative, cross-functional working atmosphere that fosters

  professional growth

  and development.
• Competitive compensation, benefits, and

  flexibility

  for remote or hybrid work.
• The chance to make an

  impact in the biotech industry

  , ensuring compliance while driving continuous improvements in labeling and regulatory processes.