Senior Manager, Global Regulatory Affairs CMC

Scorpion Therapeutics; Boston (MA); On-site; USD 150,000 - 180,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with match

Disability and life insurance

Tuition reimbursement

Paid volunteer time off

Holidays and well-being benefits

Sick time and paid vacation

Job summary

Scorpion Therapeutics is seeking a Regulatory CMC professional to lead regulatory strategies for clinical and post-market activities. The role involves coordinating with GRA CMC Product leads, ensuring compliance with global CMC requirements, and guiding submissions across development stages.

You will work with Health Authorities, draft documentation, and communicate regulatory developments to stakeholders, requiring attention to detail and strong collaboration across teams.

Qualifications

• BS/BA in a scientific discipline; advanced degree preferred.
• 6+ years regulatory CMC or device experience, including major variations and support for IND/IMPD or NDA/BLA.
• Strong understanding of global regulatory CMC requirements.
• Excellent written and oral communication; leadership and teamwork.

Responsibilities

• Lead execution of regulatory CMC strategies for assigned products.
• Serve as RA CMC delegate for the GRA CMC Product Lead across clinical development and commercial lifecycle.
• Apply global regulatory CMC regulations to enhance regulatory success and compliance.
• Plan, execute, and manage regulatory submissions per the strategy from GRA CMC Product/Device leads.
• Define CMC content (data/documentation) requirements and review for conformance; anticipate future challenges.
• Support CMC preparation for meetings with Health Authorities.
• Interact with international Health Authorities on administrative topics.
• Evaluate change proposals for global regulatory impact; ensure and enhance regulatory compliance.
• Communicate developments impacting regulatory success to stakeholders; exercise sound judgment and timely escalation.

Skills

Regulatory CMC knowledge

Communication skills

Leadership & teamwork

Attention to detail

Education

BS/BA in a scientific discipline

Advanced degree preferred

Job description

Responsibilities

• - With some supervision, lead execution of regulatory Chemistry, Manufacturing & Controls (CMC) investigational, registration, and/or post-approval strategies for assigned products.
• - Serve as RA CMC delegate for the GRA CMC Product Lead across clinical development and commercial lifecycle.
• - Apply global RA CMC regulations and guidelines to enhance regulatory success and compliance.
• - Use precedents and regulatory intelligence to support robust, accurate submissions.
• - Plan, execute, and manage regulatory submissions per the strategy from GRA CMC Product/Device leads.
• - Define CMC content (data/documentation) requirements and review for conformance; anticipate future challenges.
• - Support CMC preparation for meetings with Health Authorities.
• - Interact with international Health Authorities on administrative procedural topics.
• - Evaluate change proposals for global regulatory impact; ensure and enhance regulatory compliance.
• - Communicate developments impacting regulatory success to stakeholders; exercise sound judgment and timely escalation.

Qualifications

• - BS/BA in a scientific discipline; advanced degree preferred.
• - 6+ years pharmaceutical Regulatory CMC or Device experience, including major variation/amendment leadership and/or support for initial IND/IMPD or initial NDA/BLA (equivalent industry experience considered).
• - Strong understanding of scientific principles and global regulatory CMC requirements (drug development and post-market support).
• - Proven ability to understand/communicate regulatory strategy; analytical attention to detail; assess alternative approaches.
• - Excellent written and oral communication; emerging leadership and teamwork; inclusive culture.

Benefits

• - Medical, dental, vision, 401(k) with match, disability and life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, and paid vacation are mentioned.