Director, Promotional Compliance & Launch Strategy

Otsuka America Pharmaceutical Inc.; Juneau (AK); Remoto; USD 186.000 - 279.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical coverage

Dental coverage

Vision coverage

Life insurance

Descrizione del lavoro

Otsuka America Pharmaceutical Inc. is seeking a qualified Regulatory Affairs professional focused on promotional labeling compliance for prescription drug and device products.

The role involves strategic regulatory guidance, review of promotional messaging, and cross-functional partnership to support rare disease launch initiatives. The candidate will monitor FDA rules, ensure timely submissions to OPDP, and train internal teams on promotional compliance.

Competenze

• 6+ years of experience in pharmaceutical advertising and promotion compliance
• Experience leading or supporting pharmaceutical product launches
• Experience supporting rare disease products
• Strong regulatory risk management guidance
• Understanding of U.S. regulatory requirements
• Excellent communication of complex scientific concepts
• Knowledge of product labeling and FDA rules

Mansioni

• Review and approve promotional materials for compliance
• Provide strategic regulatory guidance during pre-launch and launch activities
• Coordinate cross-functionally with Commercial, Medical, Legal and Regulatory teams
• Ensure submissions to OPDP on FDA Form 2253 in a timely manner
• Monitor regulatory changes and update processes accordingly
• Deliver training on promotional compliance to staff and affiliates
• Liaise with OPDP and support regulatory discussions as needed
• Lead or mentor promotion compliance team members

Conoscenze

Regulatory strategy

Cross-functional collaboration

FDA promotional rules

Regulatory guidance

Communication

MS Office

Veeva PromoMats

CREDO

Outlook/Teams

Adobe Acrobat

Formazione

Bachelor’s Degree; PharmD/PhD/MS preferred

Strumenti

MS Office

Veeva PromoMats

CREDO

Outlook

Descrizione del lavoro

Otsuka America Pharmaceutical Inc. is seeking a qualified Regulatory Affairs professional focused on promotional labeling compliance for prescription drug and device products.

The role involves strategic regulatory guidance, review of promotional messaging, and cross-functional partnership to support rare disease launch initiatives. The candidate will monitor FDA rules, ensure timely submissions to OPDP, and train internal teams on promotional compliance.