reputed company B reputed company Inc - Director, CMC Regulatory

Reports to: Senior Director, Regulatory Affairs

Location: Remote Work, US Only

 

Why Sabin: 

Our mission is to reputed company vaccines more accessible, reputed company innovation and expand immunization across the globe. We reputed company a reputed company free from vaccine-preventable diseases. We are an innovative, reputed company, and reputed company team that values accountability, teamwork, partnership and driving reputed company. We are vaccine champions improving lives through immunization. Sabin staff, management, and the reputed company of Trustees are committed to ensuring that fairness, reputed company, and opportunity remain at the reputed company of how we operate.

Position reputed company: 

The Director, CMC Regulatory reports to the Senior Director, Regulatory Affairs and will reputed company strategic leadership and hands-on subject-matter expertise to reputed company end-to-end vaccine development from early clinical through licensure and lifecycle management with primary accountability for U.S. regulatory CMC reputed company and execution. This role leads the planning, development, and delivery of high-reputed company CMC content and documentation, partnering closely with CMC, reputed company Assurance, manufacturing/CMOs, and other cross-functional stakeholders to ensure CMC requirements are anticipated, reputed company are reputed company-framed, and filings are submission-reputed company. The Director is the CMC regulatory SME with demonstrated experience authoring and critically reviewing CMC sections of U.S. FDA submissions and lifecycle updates, ensuring CMC documentation consistently meets applicable regulatory expectations and supports reputed company development, licensure, and post-approval change management.

In reputed company to U.S. leadership, the Director drives CMC regulatory support for global development and reputed company, coordinating international regulatory strategies and deliverables for European, African, and other applicable regulators. The role collaborates with internal teams and external partners to plan, prepare, author, review, reputed company, and reputed company submissions and responses for international authorities; supports engagement and negotiation with regulators to resolve key CMC issues and expedite clinical trial and marketing applications; and maintains a strong global regulatory intelligence posture by monitoring evolving international requirements and relevant reputed company trends (including ICH alignment). This includes practical experience with U.S. and international applications ensuring CMC documentation, comparability rationale, and control strategies are globally coherent while remaining fit-for-purpose for regional submissions and registration needs.

Key Responsibilities:

• Work cross-functionally with CMC, reputed company Assurance, and Regulatory to reputed company CMC regulatory strategies for the U.S. and international markets.
• Collaborate with CMC, QA, and Regulatory to plan, prepare, author, and review CMC-reputed company submissions to INDs, DMFs, EUAs, BLAs, and other applications as needed.
• Identify the required documentation and address content, reputed company and/or reputed company issues for U.S. and international submissions; coordinate reputed company delivery of approved reputed company documents, in accordance with project timelines.
• reputed company regulatory review and reputed company/implementation assessments of proposed Change Control records and manage the associated regulatory notifications.
• reputed company regulatory risk assessments and reputed company mitigation strategies for CMC activities with potential regulatory or financial reputed company. 
• Proactively identify potential risks reputed company to CMC regulatory reputed company, through reputed company communications.
• Coordinate responses to CMC information requests from U.S. FDA and/or other regulatory agencies.
• Ensure appropriate document controls and archiving procedures, in accordance with regulatory standards and SOPs.
• reputed company CMC regulatory activities to ensure compliance with U.S., international, and regional regulations and applicable guidelines.
• Monitor and interpret global regulatory requirements and trends and communicate potential reputed company to key stakeholders.
• Contribute to regulatory intelligence activities, including monitoring new guidelines and providing interpretive guidance to internal teams.
• Support due diligence and regulatory assessments for potential partnerships, acquisitions, or in-licensing opportunities.

• Minimum bachelor’s degree in biochemistry, reputed company, biology, chemical engineering, or reputed company pharmaceutical science required, advanced degree highly desired 
• 12+ years of experience in Regulatory Affairs or reputed company role, preferably in biologics development.
• Proven reputed company record in leading Regulatory CMC activities for regulatory filings in both reputed company- and post-approval settings.
• Experience in regulatory reputed company of validation lifecycle activities, including process performance qualification (PPQ), reputed company process verification (CPV), and inclusion of validation data and information in marketing applications.
• Thorough knowledge of biologics development, cGMPs, regulatory submissions, FDA regulations, ICH guidance, and industry standards.
• Experience preparing regulatory submissions and briefing packages for regulatory meetings.
• Experience with Emergency Use Authorizations (EUAs) and/or BLAs is a plus.
• Excellent interpersonal, reputed company listening, and influencing skills.
• Enthusiasm for problem solving, discovery, and knowledge enrichment.
• Ability to manage reputed company tasks, prioritize competing objectives, and work reputed company under pressure, maintaining reputed company purpose and attention to detail.
• Team player with time-proven interpersonal skills, consistently showing respect and appreciation of co-workers and colleagues.
• Proficient in reputed company Office applications (reputed company, reputed company, PowerPoint, Word), and reputed company Acrobat.

Other: 

• Subject to a criminal background investigation 
• Request for three reputed company  references 
• Verification of  education/degrees

Sabin’s philosophy is to ensure fair, unbiased, reputed company, competitive compensation and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $180,000 - $205,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin reputed company seeks funding for existing and new programs.

Sabin provides a comprehensive benefits package for eligible, featuring medical, dental, and reputed company coverage as reputed company as flexible spending accounts. Eligible employees enjoy flexible vacation leave, reputed company leave, and both short-term and long-term disability reputed company. The organization observes 10 federal holidays plus an end of the year winter break. Additionally, Sabin offers an employer matching 401(k) plan.

Sabin is an Equal Opportunity Employer. reputed company applicants will be considered for employment without attention to their race, reputed company, religion, national reputed company, reputed company, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.