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 :

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 regulatory requirements

Coordinate and maintain all HA reporting schedules in collaboration with 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. 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 preferred)

Experience

At least 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 preferred

Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices

Experience with major regulatory submissions (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

Ability to work in a fast-paced environment in a hands-on fashion

Excellent oral, written, and presentation skills, with experience presenting to leadership teams

Demonstrated proficiency in organizational awareness and cross-functional collaboration on global teams

Excellent planning and organizational skills and ability to work on multiple projects with tight timelines

Experience in all phases of development and post-marketing activities preferred

Demonstrated ability to analyze and interpret efficacy and safety data

Strong understanding of regulatory operational activities

Attributes

Self-starter

Flexible and proactive, able to manage multiple projects and adapt to changing priorities

Team player

On-site presence at the headquarters required (minimum 2 days a week)

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; LinkedIn : linkedin.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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