Senior Director, Global Regulatory Strategy

About the Role >>> Senior Director, Global Regulatory Strategy 

As the Senior Director, Global Regulatory Strategy reporting to the Senior Vice President of Regulatory Affairs, your main responsibilities will include the following:  

• Leading the development and execution of innovative regulatory strategies supporting Olema products  
• Representing Regulatory Affairs on cross-functional teams as the subject matter expert and providing regulatory guidance and oversight to the global project teams
• Providing strategic and tactical guidance and leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, IMPD etc.)  

This role is based either out of our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%. 

Your work will primarily encompass:  

• Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed  
• Represent Regulatory Affairs as the SME across cross-functional teams and provide regulatory guidance/oversight to the global project teams, Study Execution Teams, and the Executive Committee  
• Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices (e.g., companion diagnostics)  
• Be accountable for, provide both strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DSUR, IMPD etc.)  
• Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives  
• Proactively identify gaps and develop risk mitigation strategies for regulatory submissions in alignment with the team(s) and management 
• Ensure Olema’s regulatory activities are robust and in compliance with Health Authority (HA) regulatory requirements  
• Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams  
• Serve as the point of contact with external parties and vendors supporting regulatory activities (e.g., CROs, contractors etc)   
• Participate in and contribute to cross-functional and departmental objectives  
• Maintain flexibility to adapt and accommodate additional duties as assigned  

And will also include the following:  

• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions  
• Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)  
• Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives, policies and their potential impact on Olema’s programs  
• Lead the global Regulatory team(s) and ensure execution of the regulatory strategies to achieve company objectives  
• Mentor and develop colleagues in the Regulatory department   

Ideal Candidate Profile  >>> Innovative Experienced Regulatory Strategy Leader  

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 in a scientific discipline  
• Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred   

Experience:  

• 12 years’ experience in Regulatory Affairs in Pharma/Biotech  
• Minimum of 3 years direct leadership experience  
• Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions  
• Experience with leading the NDA/BLA or Marketing Applications is desirable.) 
• Experience in Oncology Therapeutic area is required 
• Experience with development and execution of regulatory strategies in Oncology TA is required  
• Ability to work in a fast-paced environment in a hands-on fashion  
• Excellent oral, written, and presentation skills  
• Strong organizational skills  

Attributes:  

• Self-starter  
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities

The base pay range for this position is expected to be $270,000 - $290,000 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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