- Serve as the Regulatory Operations Lead on project submission planning and submission processes, while proactively managing critical operational issues, and ensuring timely submission.
- Provide regulatory operations expertise and leadership to cross functional teams supporting Olema's pipeline (Review clinical protocols, informed consent forms, Investigator's Brochures, CMC, site documentation etc. for regulatory compliance).
- Oversee and prepare documentation to support global regulatory filings to ensure accuracy, applicability, consistency, and control of regulatory documents. Interact with SMEs for accuracy of content.
- Assist the Global Regulatory Lead in meetings for response to Heath Authority requests, content verification and follow-ups with functional leads.
- Coordinate and prepare responses to Requests for Information from health authorities.
- Provide regulatory eCTD submission support to INDs, CTAs, IMPDs. NDAs, JNDA/BLAs and other regulatory submissions.
- Conduct operational risk assessments and develop robust mitigation measures.
- Maintain and track all regulatory submissions to Health Authorities and the Health Authority correspondences.
- Identify, implement, and administrate enterprise document management systems and publishing tools such as: file transfer, tracking and archival.
- Provide expert support and guidance on Regulatory Information Management to the teams.
- Advise and train on acceptable eCTD and document publishing formats to ensure compliance globally across industry standards.
- Perform quality assurance of submission documents and published output to ensure compliance with global eCTD requirements.
- Assist with development and implementation of regulatory processes related to submission standards, working practices and quality controls.
- Monitor changes in regulations and keep project teams and management informed of such changes.
- Maintain expertise with current and future global regulatory submission standards and their implementation within Olema.
- Build strong partnerships with functions and key stakeholders within Olema, and share knowledge and expertise with teams.
- Assist the Head of Regulatory Affairs and Quality Assurance in Departmental Operations and vendor management.
- BS or MS in a relevant discipline is required.
- Knowledge and experience of eCTD submissions.
- Knowledge and experience with enterprise document management systems (eDMS), preferably Veeva regulatory information management.
- Knowledge of U.S. and international regulations including cGMP, GCP, GPV, GLP, ICH guidance documents.
- Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking.
- Minimum 10 years pharmaceutical industry experience in Regulatory Affairs.
- People management experience is preferred.
- Demonstrated leadership skills while working in a fast paced and changing environment.
- Experience in build and submission of NDA/BLA and life-cycle management is highly desirable.
- Displays strong proactive acumen and inclusive way of engagement to drive decision making, turnaround time improvement and effective ways of working.
- Influences the cross-functional team to adapt fit-for purpose solutions to meet the expected timelines.
- Ability to understand, analyze and develop recommendations from multiple complex sources such as scientific and operational perspectives.
- Excellent written and verbal communication skills.
- Excellent negotiation and organizational skills.
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Director, Regulatory Affairs Operations - Boston, United States - Olema Oncology
Description
Who We Are >>> Why You Should Work With UsOlema 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 3 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 , 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 theircamaraderie , 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 >>> Director, Regulatory Affairs Operations
As the Director of Regulatory Affairs Operations, reporting to the Vice President of Regulatory Affairs and Quality Assurance, you will develop and lead global regulatory operations to support the advancement of multiple clinical trials. This role provides leadership in the operational guidance and execution of regulatory concepts within cross - functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables.
This role is based out of our Cambridge, MA office and may require 15% travel.
Your work will primarily encompass:
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:
#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.
