Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

About the Role >>> Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

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

1. Lead the development of the New Drug Application (NDA)  
2. Lead the development and execution of innovative regulatory strategies supporting Olema products
3. Represent Regulatory Affairs on cross-functional teams as the subject matter expert and provide regulatory guidance and oversight to the global project teams, Study Execution Teams, and the Executive Committee
4. Provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD etc.) 

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

Your work will primarily encompass: 

Lead the development and submission of the NDA for the company's lead program

• Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed 
• Represent Regulatory Affairs on cross-functional teams as the SME and provide regulatory guidance and 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 
• Provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD etc.) 
• Represent Olema with Global Health Authorities and lead Agency interactions to achieve company objectives 
• Identify gaps and develop risk mitigation strategies for the regulatory submissions 
• Ensure Olema’s regulatory activities are robust and are in compliance with Health Authority (HA) regulatory requirements 
• Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams 
• Be flexible to adapt and accommodate additional duties as assigned 

And will also include: 

• 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 and impact on Olema’s programs 
• Lead the global regulatory team(s) and ensure execution of the Regulatory strategies to achieve the company objectives 
• Mentor and develop other regulatory colleagues in the department 
• Support SVP Regulatory Affairs, as required 

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

• Minimum of 12 years’ experience in Regulatory Affairs in Pharma/Biotech 
• Minimum of 3 years direct leadership experience
• Experience with development and execution of regulatory strategies in Oncology Therapeutic area is strongly preferred 
• Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
• Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), is a must  
• Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on the regulatory strategy for a given product is required
• Ability to work in a fast-paced environment in a hands-on fashion 
• Excellent oral, written, and presentation skills, with experience presenting to the leadership teams
• Demonstrated proficiency in organizational awareness, including experience working cross-functionally representing the Regulatory Affairs function and on global teams
• Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines
• Experience in all phases of development and post marketing activities is highly preferred
• Demonstrated ability to analyze and interpret efficacy and safety data
• Strong understanding of regulatory operational activities

Attributes

• Self-starter 
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities 
• Team Player 
• On site presence at the headquarter is required (minimum 2 days a week)

The base pay range for this position is expected to be $275,000-$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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