AD/Director, Regulatory Affairs CMC

BridgeBio Inc.; United States; Sur place; USD 190 000 - 285 000; Plein temps

Résumé du poste

Scorpion Therapeutics seeks a Regulatory Affairs CMC professional focused on global regulatory strategy and dossier preparation for drug development in biopharma. The role reports to the Executive Director and operates remotely in the U.S. with quarterly visits to San Francisco.

You will develop CMC strategies, manage global submissions (ROW), coordinate regulator queries, and ensure compliance with global regulations while leveraging AI tools to increase efficiency.

Qualifications

• 7+ years in pharmaceutical/regulatory CMC functions.
• Bachelor's degree in life sciences or related field.
• Excellent communication and project management skills.
• Proficiency with Veeva and document management systems.
• Demonstrated ability to leverage AI tools for efficiency.

Responsabilités

• Develop CMC regulatory strategies for global submissions.
• Manage creation and submission of regulatory documentation (ROW marketing applications).
• Coordinate responses to health authority questions.
• Support interactions with regulators.
• Ensure compliance with global regulations.

Connaissances

Excellent communication

Project management

Formation

Bachelor's degree in life sciences or related field

Outils

Veeva

AI tools for regulatory efficiency

Description du poste

Role

Regulatory Affairs CMC professional focused on global regulatory strategy and dossier preparation for drug development in biopharma, reporting to the Executive Director.

Responsibilities

• develop CMC strategies
• manage the creation and submission of regulatory documentation (including ROW marketing applications)
• coordinate responses to health authority questions
• support interactions with regulators
• ensure compliance with global regulations

Qualifications

• minimum 7 years in pharmaceutical/regulatory CMC functions
• bachelor's degree in life sciences or related field
• excellent communication and project management skills
• proficiency with document management systems like Veeva
• demonstrated ability to leverage AI tools for efficiency

HighValue: involvement in biopharma drug development, with emphasis on CMC regulatory processes, global compliance, and cross-functional collaboration.

Location

remote U.S. role requiring quarterly visits to San Francisco; salary range $190,000-$285,000 USD.