Strategic Regulatory Labeling & Promo Lead

ALKU; Los Angeles (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

ALKU is seeking an Associate Director in Los Angeles to provide strategic and operational leadership for regulatory labeling. You will be responsible for managing the development and execution of regulatory labeling strategy for the clients pipeline and marketed products, ensuring regulatory compliance and quality assurance.

The ideal candidate will have over 8 years in the biotech or pharmaceutical industry and experience in leading cross-functional teams. Knowledge of FDA regulations and strong collaboration skills are essential for this role.

Qualifications

• Minimum 8+ years in the biotech or pharmaceutical industry leading labeling.
• Experience leading cross-functional meetings and strategic discussions.
• Ability to review regulatory documents for accuracy and adherence.

Responsibilities

• Manage development and approval of labeling documents.
• Liaise with Commercial, Medical Affairs, and Legal for regulatory advice.
• Lead interactions with FDA for promotional materials submissions.

Skills

Regulatory strategy development

Cross-functional collaboration

FDA regulations knowledge

Document formatting knowledge

Education

Bachelor’s degree in life sciences or related discipline

Tools

Veeva RIM

PromoMats

Job description

ALKU is seeking an Associate Director in Los Angeles to provide strategic and operational leadership for regulatory labeling. You will be responsible for managing the development and execution of regulatory labeling strategy for the clients pipeline and marketed products, ensuring regulatory compliance and quality assurance.

The ideal candidate will have over 8 years in the biotech or pharmaceutical industry and experience in leading cross-functional teams. Knowledge of FDA regulations and strong collaboration skills are essential for this role.