Senior Manager, Regulatory Affairs Strategy

About the Role >>>Senior Manager, Regulatory Affairs Strategy

As the Senior Manager, Regulatory Affairs Strategy, reporting to the Senior Director, Regulatory Affairs, you will provide regulatory strategy support in partnership with cross functional teams and subject matter experts and manage regulatory aspects through all phases of development. 

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

Your work will primarily encompass: 

• Provides regulatory strategy support on regulatory projects 
• Uses knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals
• Participates in the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met
• Under the guidance of the Global Regulatory Leader, authors and/or reviews sections of IND/CTA, NDA/MAA/NDS, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements
• Under the guidance of the Global Regulatory Leader, liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes
• Maintains awareness of global regulatory environment and assess impact of changes on business and product development programs. Facilitate policy and development of standard interpretation of global regulation
• Manages critical issues and takes leadership for the regulatory contribution

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 required; advanced degree preferred
• Thorough understanding of drug development process in the biotechnology or pharmaceutical industry and healthcare environment including regulatory requirements and policy trends

Experience: 

• 8+ years in the biotechnology or pharmaceutical industry and a minimum of 5 years in Regulatory Affairs
• Experience supporting regulatory submissions for drugs and/or biologics, with oncology experience preferred
• Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities
• Interactions with external business partners and Regulatory Agencies

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 and written skills. Fosters open communication. Listens and facilitates discussion
• 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

The base pay range for this position is expected to be $166,000 - $181,000 annually. However the base pay and/or level 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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