Director Regulatory Affairs Innovative Medicines (IM) Labeling
Teva Pharmaceuticals
5 days ago
Remote friendly (West Chester, PA)
United States
Corporate Functions
Director of Regulatory Affairs, Innovative Medicines (IM) Labeling
Responsibilities:
- Develop and maintain labeling for an assigned portfolio of product(s); serve as labeling contact with FDA.
- Lead cross-functional labeling and Company Core Data Sheet (CCDS) development teams.
- Oversee development and maintenance of labeling SOPs and other process documents.
- Collaborate with cross-functional teams on labeling development and governance committees.
Qualifications:
- Bachelor’s degree required, preferably in life sciences, pharmacy, or related field.
- Minimum 6 years of relevant biopharmaceutical industry experience focused on U.S. drug/biologic labeling across multiple lifecycle stages.
- Experience supporting small molecule and biologic products (combination product experience a plus).
Skills/Knowledge:
- Expert-level knowledge of FDA labeling regulations and guidance (format, content, and post-marketing change submissions).
- Familiarity with Structured Product Labeling (SPL) and drug listing; CCDS and Company Core Safety Information (CCSI); Summary of Product Characteristics (SmPC); document management systems.
- Strong analytical and writing skills; ability to translate complex scientific/regulatory information into clear labeling language.
- Ability to influence and build credibility as a trusted advisor across functions and seniority levels.
- Basic understanding of drug development and worldwide regulatory labeling guidelines as applied to U.S. labeling in a global company.
- Exceptional attention to detail, organization, and ability to manage multiple priorities in a fast-paced environment.
Benefits:
- Comprehensive Health Insurance (Medical, Dental, Vision, Prescription) starting first day (if enrolled).
- 401(k) with employer match (up to 6%) and annual 3.75% Defined Contribution.
- Paid Time Off (vacation, sick/safe time, caretaker time, holidays).
- Company-paid Life and Disability insurance.
Application Instructions:
- Apply through Teva’s internal career site on Twist.
Responsibilities:
- Develop and maintain labeling for an assigned portfolio of product(s); serve as labeling contact with FDA.
- Lead cross-functional labeling and Company Core Data Sheet (CCDS) development teams.
- Oversee development and maintenance of labeling SOPs and other process documents.
- Collaborate with cross-functional teams on labeling development and governance committees.
Qualifications:
- Bachelor’s degree required, preferably in life sciences, pharmacy, or related field.
- Minimum 6 years of relevant biopharmaceutical industry experience focused on U.S. drug/biologic labeling across multiple lifecycle stages.
- Experience supporting small molecule and biologic products (combination product experience a plus).
Skills/Knowledge:
- Expert-level knowledge of FDA labeling regulations and guidance (format, content, and post-marketing change submissions).
- Familiarity with Structured Product Labeling (SPL) and drug listing; CCDS and Company Core Safety Information (CCSI); Summary of Product Characteristics (SmPC); document management systems.
- Strong analytical and writing skills; ability to translate complex scientific/regulatory information into clear labeling language.
- Ability to influence and build credibility as a trusted advisor across functions and seniority levels.
- Basic understanding of drug development and worldwide regulatory labeling guidelines as applied to U.S. labeling in a global company.
- Exceptional attention to detail, organization, and ability to manage multiple priorities in a fast-paced environment.
Benefits:
- Comprehensive Health Insurance (Medical, Dental, Vision, Prescription) starting first day (if enrolled).
- 401(k) with employer match (up to 6%) and annual 3.75% Defined Contribution.
- Paid Time Off (vacation, sick/safe time, caretaker time, holidays).
- Company-paid Life and Disability insurance.
Application Instructions:
- Apply through Teva’s internal career site on Twist.