Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

Overview

Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs at Olema Oncology. Reports to the Senior Vice President of Regulatory Affairs. Location : Boston, MA or San Francisco, CA. Domestic and international travel up to 20%.

Responsibilities

• Lead the development of the New Drug Application (NDA)
• Lead the development and execution of innovative regulatory strategies supporting Olema products
• 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
• 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 :

And will also include :

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. We are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge

Experience

Attributes

Compensation

The base pay range for this position is expected to be $275,000-$290,000 annually. The total compensation package includes equity, bonus, and benefits. Base pay may vary by location, market, knowledge, skills, and experience.

Important Information

Olema is an equal opportunity employer. We provide an open, flexible, and inclusive work environment and a summary of benefits is available for all applicants. Olema does not accept agency resumes and is not responsible for fees related to unsolicited resumes.

Fraud Alert : We are aware of employment scams. Our official email addresses end in @olema.com; our official site is olema.com; careers : olema.com / careers; : .com / company / olema-oncology. Olema does not conduct interviews via text messages, will not ask you to download anything, will never request payment, and does not make job offers without an in-person interview.

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