Sr. Scientist, Regulatory Affairs

Job Description

We invite you to join our mission of advancing the prevention and treatment of diseases. The purpose of Global Labeling is to drive labeling strategy and ensure high-quality and compliant labeling documents which, provide the safe and effective use of products for patients and healthcare providers globally.

As part of Labeling Strategy function in Global Labeling, you will be accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (e.g., CCDS, CCPPI, CCIFU) , US Labeling, and EU Labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of other country’s Local Labeling.

The Senior Scientist, Global Labeling Lead is responsible for:

• developing, maintaining, and implementing Core Labeling for assigned products in line with internal standards and guidelines

• developing, maintaining, and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines

• assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products

• providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements

• serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions for assigned products

• leading cross-functional teams to develop, review and approve Core and Local Labeling documents

• recommending strategies and labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority

Education

• Required: Bachelor’s degree in a scientific or medically related discipline.

• Preferred: Advanced degree (M.S., Pharm.D, Ph.D.).

Required Experience & Skills

• Minimum of 3 years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance).

• Experience in leading cross-functional labeling team (including senior management) exhibiting a combination of active listening skills and the confidence to address labeling issues, develop plans of action, drive consensus, and oversee completion of labeling project.

• Ability to assimilate clinical and scientific information, labeling precedent and competitor labeling, and present it concisely. Understanding of medical concepts and terminology.

• Project management skills with the ability to handle multiple projects and prioritize work accordingly.

• Proactive problem-solving ability with the ability to make appropriate recommendations/decisions.

• Tolerance for ambiguity and action-oriented.

• Strong written and oral communication skills.

• Attention to detail and accuracy.

• Ability to influence and negotiate.

Required Skills:

Adverse Event Report, Clinical Medicine, Compliance Investigations, Decision Making, Detail-Oriented, Disease Prevention, Documentations, Employee Training Programs, Labeling Compliance, Maintenance Processes, Manufacturing Compliance, Multi-Management, Negotiation, Oral Communications, Pharmaceutical Management, Policy Implementation, Proactive Thinking, Records Retention Management, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Strategy Development, Regulatory Submissions, Technical Writing

Preferred Skills:

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US and Puerto Rico Residents Only:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other