Job Description

Location: Boston, MA (Remote)

Focus: Rare disease/biologics

Job Overview: Reporting to the Head of Regulatory Affairs CMC, the Director will lead CMC regulatory strategies, align global requirements with development plans, and manage submissions and interactions with Health Authorities, driving team and corporate objectives.

Primary Job Responsibilities:

• Develop CMC regulatory strategies, pinpointing critical issues and acceleration opportunities.
• Serve as the regulatory point of contact in internal and cross-functional CMC meetings.
• Guide project teams on global CMC regulatory strategies and compliance requirements.
• Initiate and lead proactive discussions with global health authorities.
• Organize and engage in CMC regulatory interactions with agencies like FDA and EMA.
• Assist in GMP inspections and manage comprehensive regulatory submissions.
• Collaborate with external contractors to maintain and update regulatory plans.
• Oversee CMC regulatory project reviews, budget management, and routine updates.
• Keep informed on new CMC regulatory policies and manage resolution of regulatory issues.

Primary Job Requirements:

• Bachelor's in science with 10+ years in CMC Regulatory Affairs with escalating responsibility within the biopharma sector.
• Experience in securing approvals for market applications is mandatory.
• Must possess global post-approval product life-cycle management experience.
• Proven track record in strategic drug development and commercial support.
• Demonstrated success in global regulatory affairs, including drug registrations in US, EU, and beyond.
• Strong leadership with adept communication skills for influential regulatory strategy guidance.
• Independent work ethic, commendable teamwork, and excellent oral/written communication proficiency.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us

Job Tags

Similar Jobs