Manager Regulatory Affairs
Manager Regulatory Affairs
Posted on :
20-01-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
20-01-2025
Job Description
Job Title: Manager Regulatory Affairs
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
About Apogee Therapeutics
Founded in 2022 Apogee Therapeutics Inc. (Ticker: APGE) is a wellfunded Nasdaq listed company that offers the opportunity to work in a fastpaced highly dynamic environment. At Apogee you can actively contribute to shaping the company culture take on various roles and responsibilities and grow professionally.
Apogee Therapeutics Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting wellestablished mechanisms of action and incorporating advanced antibody engineering to optimize halflife and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment and we refuse to stop at “good enough.”
We are a fastpaced company committed to building an exceptional company culture founded on our C.O.R.E. values: Caring Original Resilient and Egoless.
If this sounds like you keep reading!
Role Summary
We are seeking a Manager Regulatory Affairs. This newly created role offers an opportunity to work in a fastpaced highly dynamic environment where you help shape the culture and company wear multiple hats and learn quickly. Reporting to the Director of Regulatory Affairs you will have the opportunity to oversee the implementation of regulatory strategies for Apogee’s products in collaboration with project teams and the regulatory affairs department. In this highly visible role you will facilitate preparation and completion of documentation to support submissions to the FDA and to exUS regulatory agencies. Additionally you will serve as the primary interface with regulatory publishing to ensure timely and compliant submissions and represent regulatory affairs on clinical study and execution teams.
Key Responsibilities
What We Offer
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex gender identity sexual orientation race color religion national origin disability protected Veteran status age or any other characteristic protected by law.
To review our privacy policy click here
Founded in 2022 Apogee Therapeutics Inc. (Ticker: APGE) is a wellfunded Nasdaq listed company that offers the opportunity to work in a fastpaced highly dynamic environment. At Apogee you can actively contribute to shaping the company culture take on various roles and responsibilities and grow professionally.
Apogee Therapeutics Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting wellestablished mechanisms of action and incorporating advanced antibody engineering to optimize halflife and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment and we refuse to stop at “good enough.”
We are a fastpaced company committed to building an exceptional company culture founded on our C.O.R.E. values: Caring Original Resilient and Egoless.
If this sounds like you keep reading!
Role Summary
We are seeking a Manager Regulatory Affairs. This newly created role offers an opportunity to work in a fastpaced highly dynamic environment where you help shape the culture and company wear multiple hats and learn quickly. Reporting to the Director of Regulatory Affairs you will have the opportunity to oversee the implementation of regulatory strategies for Apogee’s products in collaboration with project teams and the regulatory affairs department. In this highly visible role you will facilitate preparation and completion of documentation to support submissions to the FDA and to exUS regulatory agencies. Additionally you will serve as the primary interface with regulatory publishing to ensure timely and compliant submissions and represent regulatory affairs on clinical study and execution teams.
Key Responsibilities
- Interact with project teams clinical study teams management consultants and collaborators to facilitate timely acceptance/approval of regulatory submissions including INDs CTAs NDAs BLAs and PIPs/PSPs among others.
- Support the data collection and crossfunctional authorship for regulatory documents. Proofread edit and prepare documents for inclusion in regulatory submissions; coordinate with multiple departments to obtain content needed for submissions.
- Communicate timelines for regulatory submissions to individuals and departments and follow up to ensure timely submission.
- Serve as the primary interface with regulatory publishing to ensure compliant electronic submissions to FDA and exUS regulatory agencies as needed.
- Appropriately archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system.
- Implement use of templates and guidelines for documentation to be included in regulatory submissions; provide formatting assistance and advice to team members.
- With mentoring and guidance from the regulatory affairs leadership team understand and communicate US and international regulatory requirements to ensure quality documents are submitted either directly or in collaboration with a CRO or corporate partner.
- Support global regulatory leads on clinical study and execution teams to ensure that clinical trial deliverables timelines and objectives are met.
- BS/MS/PhD (or equivalent) in regulatory affairs or related scientific discipline.
- Regulatory Affairs Certification (RAC) credential preferred.
- A minimum of 4 years of regulatory experience working in drug development in the biopharmaceutical industry.
- Experience interacting with health authorities including FDA and EMA (preferred).
- Strong project management skills with a high sense of urgency ability to collaborate and influence effectively crossfunctionally.
- Strong communication skills with an ability to present to a variety of stakeholders and tailor message accordingly.
- Experience working in Veeva Regulatory Information Management (RIM) platforms eCTD submissions and Microsoft Office SharePoint/Teams
- Successfully exhibit Apogee’s C.O.R.E. values: Caring Original Resilient and Egoless.
- Ability and willingness to travel up to 10%.
What We Offer
- A great culture grounded in our C.O.R.E. values: Caring Original Resilient and Egoless
- Opportunity to work in a fastpaced highly dynamic environment where you help shape the culture and company wear multiple hats and learn quickly
- Market competitive compensation and benefits package including base salary performance bonus equity grant opportunities health welfare & retirement benefits
- Flexible PTO
- Two oneweek companywide shutdowns each year
- Commitment to growing you professionally and providing access to resources to further your development
- Apogee offers regular all team inperson meetings to build relationships and problem solve
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex gender identity sexual orientation race color religion national origin disability protected Veteran status age or any other characteristic protected by law.
To review our privacy policy click here
/jobs/view/50b7a49015b0e647046b38ae2d10895d
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
