Skip to main content

This job has expired

You will need to login before you can apply for a job.

Sr./Director, Global Regulatory Strategy Lead - Regulatory Affairs

Employer
Olema Oncology
Location
Boston, Massachusetts
Start date
Sep 19, 2022

View more

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

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

Olema Oncology (OLMA) is a biopharmaceutical company developing innovative targeted therapies for women’s cancers. Our lead program, OP-1250, a potential best-in-class complete estrogen receptor antagonist (CERAN) / selective estrogen receptor degrader (SERD), is in Phase 2 clinical development for the treatment of ER+/HER2- Breast Cancer. Our goal is to transform the standard of care for women living with cancer by developing more convenient and effective therapies.

Onto something bigger, 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. 

Strategically located in two large biotech hubs – San Francisco, CA and Cambridge, MA – we offer a flexible work environment and the best of both coasts

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

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

(a) Lead the development and execution of innovative regulatory strategies supporting Olema products

(b) 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

(c) 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 our Boston, MA or San Francisco, CA office.

Your work will primarily encompass:

  1. Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed
  2. 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
  3. Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices
  4. Provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD etc.)
  5. Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives
  6. Identify gaps and develop risk mitigation strategies for the regulatory submissions
  7. Ensure Olema’s regulatory activities are robust and are in compliance with Health Authority (HA) regulatory requirements
  8. Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams
  9. Be flexible to adapt and accommodate additional duties as assigned

And will also include the following:

  1. Lead the development of Regulatory Affairs department policies, SOPs, and work instructions
  2. Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)
  3. Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives and impact on Olema’s programs
  4. Lead the global regulatory team(s) and ensure execution of the Regulatory strategies to achieve the company objectives
  5. Mentor and develop other regulatory colleagues in the department

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:

  • 10-12 years’ experience in Regulatory Affairs in Pharma/Biotech
  • Minimum of 3 years direct leadership experience
  • Experience in Oncology Therapeutic area is strongly preferred
  • Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions (IND/CTx to NDA/BLA or Marketing Applications)
  • Experience with development and execution of regulatory strategies in Oncology TA is strongly preferred
  • Ability to work in a fast-paced environment in a hands-on fashion
  • Excellent oral, written, and presentation skills
  • Strong organizational skills

Attributes:

  • Self-starter
  • Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities
  • Ability to travel domestically and internationally, as required (approximately 25%)

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.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert