AD/Director, Regulatory Affairs CMC

The role

This regulatory professional will manage internal regulatory processes and prepare documents for regulatory submissions. They will develop global CMC regulatory strategies and collaborate with cross-functional teams to meet business objectives.

What you will do

• Develop global CMC regulatory strategies in collaboration with manager and CMC subject-matter experts
• Collaborate with cross-functional teams to create and prepare CMC sections of regulatory dossiers
• Help prepare and communicate timelines
• Plan and coordinate preparation of the CMC sections
• Manage the author, review and approval workflows
• Provide recommendations to team on regulatory strategy
• Provide RA CMC support for Health Authority interactions
• Work with team on strategy and responses to Health Authority CMC questions
• Provide support from triage through finalization of regulatory responses
• Maintain current knowledge of applicable global regulations, guidance and standards

Required qualifications

• Minimum of a bachelor’s degree
• Minimum of 7 years experience in pharmaceutical or related industry in regulatory affairs, CMC or related function, eg, drug development/manufacturing/QC/QA
• Excellent communication skills
• Attention to detail
• Independently able to manage projects and deliver output in a timely manner with limited direction of manager
• Excellent computer skills, e.g., Microsoft suite of applications/software and document management system such as Veeva
• Demonstrated self-starter with the ability to take initiative, work independently, and proactively identify and execute tasks with minimal supervision
• Excellent interpersonal, active listening, and influencing skills
• Demonstrated ability to leverage artificial intelligence tools to support and enhance the execution of complex tasks

Nice to have

• life sciences discipline preferred

Benefits

• Market-leading compensation
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Pre-tax commuter benefits (transit and parking)
• Referral bonus for hired candidates
• Subsidized lunch and parking on in-office days
• 100% employer-paid medical, dental, and vision premiums for you and your dependents
• Health Savings Account (HSA) with annual employer contributions
• Flexible Spending Accounts (FSA)
• Fertility & family-forming benefits
• Expanded mental health support (therapy and coaching resources)
• Hybrid work model with flexibility

About the company

BridgeBio uses a moneyball for biotech approach, pooling projects and promising early-stage research from academia together to reduce risk and unleash innovation. They build bridges to groundbreaking advancements in rare disease and develop medicines for patients with unmet needs.