Remote Principal Regulatory Labeling Strategist

Opus Regulatory, Inc.; United States; À distance; USD 210 000 - 300 000; Plein temps

Avantages offerts par ce poste

Health coverage

Dental coverage

Vision coverage

Prescription drug coverage

Life Insurance

Short-Term Disability

401(k)

Résumé du poste

Opus Regulatory, Inc. is seeking a Principal Consultant, Regulatory Affairs Labeling to manage regulatory labeling requirements for multiple projects across US and international markets.

The role involves leading labeling strategy, coordinating with client SMEs and authorities, and delivering compliant labeling content. You will drive timelines, review CCDS and TPL contents, and provide expert guidance on US, EU, and ICH requirements within a dynamic, client-focused team.

Qualifications

• 5-10+ years pharmaceutical regulatory affairs experience within Labeling.
• Bachelor’s degree; advanced degree preferred.
• Global and international regulatory experience.
• Proven project management skills.
• Ability to work independently and to be innovative in tackling operational challenges.

Responsabilités

• Manage daily regulatory labeling requirements for one or more projects across US/EU/ROW.
• Design and implement labeling strategy and operations.
• Lead preparation and update of Target Product Label (TPL) and CCDS content.
• Provide regulatory labeling expertise within client teams and with authorities.
• Support RA requirements for drug products and assess CCDS content risks.
• Develop and drive regulatory labeling timelines and deliverables.
• Represent client RA in meetings and cross-workstream activities.

Connaissances

Regulatory strategy

Global experience

Project management

Independent work

Formation

Bachelor’s degree

Advanced degree in science (preferred)

Description du poste

Opus Regulatory, Inc. is seeking a Principal Consultant, Regulatory Affairs Labeling to manage regulatory labeling requirements for multiple projects across US and international markets.

The role involves leading labeling strategy, coordinating with client SMEs and authorities, and delivering compliant labeling content. You will drive timelines, review CCDS and TPL contents, and provide expert guidance on US, EU, and ICH requirements within a dynamic, client-focused team.