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Senior Manager, Regulatory Affairs Strategy

Employer
Olema Oncology
Location
San Francisco, California
Start date
Feb 18, 2024

View more

Discipline
Marketing, Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Who We Are >>> Why You Should Work With Us

Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers. Olema’s lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 2 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com, or follow us on Twitter and LinkedIn.

Onto something big, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer. 

Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses. 

While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities. While at home, employees can make the most of their time – whether that’s picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees the best of both work models.  

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, CA or 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. 

#LI-CK1

Important Information >>>

We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.

Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations. The health and safety of our employees is important to us!

Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

Additional Note/Fraud Alert:  Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.  Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.

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