Associate Director, Regulatory Affairs CMC
Olema Oncology, San Francisco, California, United States, 94199
Associate Director, Regulatory Affairs CMC
All candidates should make sure to read the following job description and information carefully before applying. Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for
our patients, for your career, for what’s beyond .
You can view our latest corporate deck and other presentations here .
About the Role >>> Associate Director, Regulatory Affairs CMC
As the Associate Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, you will be responsible for developing and executing the CMC regulatory strategies for Olema product(s) in development and post-approval. You will ensure these strategies are aligned with Health Authority requirements globally and provide guidance and oversight for development of high quality and on-time CMC sections of the regulatory submissions. In addition, you will provide CMC regulatory strategy support and guidance to cross-functional teams within the organization.
This role is based out of our San Francisco, CA office and will require 10% travel.
Your work will primarily encompass:
Provide CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs)
Support regulatory agency interactions to ensure alignment on CMC strategies for initial INDs/CTAs, marketing registration applications, supplements and variations.
Provide CMC support on the global regulatory plan, development plans/clinical study designs and risk assessments
Proactive and effective communication of critical issues and potential mitigations with teams, senior management and key stakeholders in a timely manner
Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
Collaborates well with internal and external teams (CMC, QA, Supply Chain, RA etc)
Assist with the planning, compilation, review, approval and submission of high-quality CMC related sections of regulatory submissions, including responses to questions from various regulatory authorities, working in collaboration with partners in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain and other business partners
Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation
Support interactions with regulatory agencies during inspections
Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
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 is required, preferably in a scientific field; advanced degree is a plus
Excellent knowledge of current CMC regulations and regulatory procedures
Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
Deep understanding of clinical trial requirements for initial INDs/CTAs for all development phases early to late-stage
Experience:
Minimum 8 years of experience working in clinical research, biotech, and/or pharmaceutical company, with minimum 6 years of Regulatory Affairs experience within clinical research or pharmaceutical
Experience in small molecule drug development required; experience in the oncology therapeutic area is a plus
Global CMC regulatory experience for clinical trials is required
Post approval (commercial) experience is a plus
Experience with eCTD requirements and electronic submissions
Experience with international regulatory submissions and processes is a strong plus
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, written and presentation skills
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
Fosters open communication. Listens and facilitates discussion
Maintain learner mindset, with an ability to adapt to an ever-changing environment
Proven ability to prioritize and manage multiple tasks and requests efficiently
The base pay range for this position is expected to be
$190,000 - $205,000
annually, however the base pay 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.
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.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert
: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @ . Our official corporate website is ; our careers page is /careers ; our LinkedIn page is /company/olema-oncology .Please visit these links for official information from Olema. Communication from any other variant is fraudulent. xsgimln Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront paymentsof any kind, and does not make job offers without an in-person interview.
All candidates should make sure to read the following job description and information carefully before applying. Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for
our patients, for your career, for what’s beyond .
You can view our latest corporate deck and other presentations here .
About the Role >>> Associate Director, Regulatory Affairs CMC
As the Associate Director, Regulatory Affairs CMC, reporting to the Senior Director, Regulatory Affairs CMC, you will be responsible for developing and executing the CMC regulatory strategies for Olema product(s) in development and post-approval. You will ensure these strategies are aligned with Health Authority requirements globally and provide guidance and oversight for development of high quality and on-time CMC sections of the regulatory submissions. In addition, you will provide CMC regulatory strategy support and guidance to cross-functional teams within the organization.
This role is based out of our San Francisco, CA office and will require 10% travel.
Your work will primarily encompass:
Provide CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs and MAAs)
Support regulatory agency interactions to ensure alignment on CMC strategies for initial INDs/CTAs, marketing registration applications, supplements and variations.
Provide CMC support on the global regulatory plan, development plans/clinical study designs and risk assessments
Proactive and effective communication of critical issues and potential mitigations with teams, senior management and key stakeholders in a timely manner
Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
Collaborates well with internal and external teams (CMC, QA, Supply Chain, RA etc)
Assist with the planning, compilation, review, approval and submission of high-quality CMC related sections of regulatory submissions, including responses to questions from various regulatory authorities, working in collaboration with partners in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain and other business partners
Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management. Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation
Support interactions with regulatory agencies during inspections
Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
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 is required, preferably in a scientific field; advanced degree is a plus
Excellent knowledge of current CMC regulations and regulatory procedures
Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
Deep understanding of clinical trial requirements for initial INDs/CTAs for all development phases early to late-stage
Experience:
Minimum 8 years of experience working in clinical research, biotech, and/or pharmaceutical company, with minimum 6 years of Regulatory Affairs experience within clinical research or pharmaceutical
Experience in small molecule drug development required; experience in the oncology therapeutic area is a plus
Global CMC regulatory experience for clinical trials is required
Post approval (commercial) experience is a plus
Experience with eCTD requirements and electronic submissions
Experience with international regulatory submissions and processes is a strong plus
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, written and presentation skills
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
Fosters open communication. Listens and facilitates discussion
Maintain learner mindset, with an ability to adapt to an ever-changing environment
Proven ability to prioritize and manage multiple tasks and requests efficiently
The base pay range for this position is expected to be
$190,000 - $205,000
annually, however the base pay 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.
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.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert
: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @ . Our official corporate website is ; our careers page is /careers ; our LinkedIn page is /company/olema-oncology .Please visit these links for official information from Olema. Communication from any other variant is fraudulent. xsgimln Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront paymentsof any kind, and does not make job offers without an in-person interview.