Senior Director, Regulatory Affairs Cmc

About the Role >>>Senior Director, Regulatory Affairs CMC 

As the Senior Director, Regulatory Affairs CMC reporting to the VP, Regulatory Affairs and Quality Assurance you will be responsible for developing and executing the CMC regulatory strategies for Olema product(s) in development and post-approval. You will ensure these strategies are aligned with Health Authority requirements globally and provide guidance and oversight for development of high quality and on-time CMC sections of the regulatory submissions. You will provide CMC regulatory strategy support and guidance to cross-functional teams within the organization. 

This role is based out of our San Francisco, CA or Cambridge, MA office and will require 10%travel. 

Your work will primarily encompass: 

• Provide CMC regulatory expertise and leadership for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs). 
• Lead negotiations with regulatory agencies to ensure alignment on CMC strategies, resolve CMC issues and oversee proactive interactions with regulators globally (US, EU and Japan) for initial INDs/CTAs, marketing registration applications, supplements and variations. 
• Provides strategic regulatory CMC direction on programs to support the global regulatory plan, development plans/clinical study designs, risk assessments, critical issue management and Health Authority interactions.  
• Proactive and effective communication of critical issues and potential mitigations with teams, senior management and key stakeholders in a timely manner.  
• Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
• Manage and ensure compliance with all reporting requirements, including annual and periodic reports. 
• Collaborate effectively with internal and external teams (CMC, QA, Supply Chain, RA etc).  
• Be responsible for planning, compilation, review, approval and submission of high-quality CMC related sections of regulatory submissions, including responses to questions from various regulatory authorities and working in collaboration with partners in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain and other business partners.  
• Maintain responsibility for all CMC Regulatory timelines. 
• Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management.
• Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation. 
• Support interactions with regulatory agencies during inspections. 
• Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs. 

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus. 
• 15+ years of drug development, including 10+ years of Regulatory Affairs experience in the Biotech/Pharmaceutical industry. 
• Expert knowledge of current CMC regulations and regulatory procedures. 

Experience: 

• Experience in small molecule drug development required; experience in the oncology therapeutic area is a plus.  
• Global CMC regulatory experience is required. 
• Post approval (commercial) experience is a plus. 
• Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP. 
• Experience with eCTD requirements and electronic submissions.  
• Experience with international regulatory submissions and processes is a strong plus. 

Attributes: 

• Strong business acumen and ability to successfully work with international and cross functional partners.  
• Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.  
• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.  
• Excellent verbal, written and presentation skills.   
• Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.  
• Fosters open communication. Listens and facilitates discussion. 

The base pay range for this position is expected to be $260,000 - $275,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

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