Tbwa Chiat/Day Inc
Manager, Regulatory Affairs
Tbwa Chiat/Day Inc, Jackson, Mississippi, United States,
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, 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 well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life 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 fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values:
C aring,
O riginal,
R esilient and
E goless.If this sounds like you, keep reading!Role SummaryWe are seeking a Manager, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, 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 ex-US 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 ResponsibilitiesInteract 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 cross-functional 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 ex-US 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.Ideal CandidateBS/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 cross-functionally.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%.The anticipated salary range for candidates for this role will be $120,000-$140,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.What We OfferA great culture, grounded in our C.O.R.E. values:
C aring,
O riginal,
R esilient and
E goless.Opportunity to work in a fast-paced, 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, one-week company-wide shutdowns each year.Commitment to growing you professionally and providing access to resources to further your development.Apogee offers regular all team, in-person meetings to build relationships and problem solve.E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify.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.
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C aring,
O riginal,
R esilient and
E goless.If this sounds like you, keep reading!Role SummaryWe are seeking a Manager, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, 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 ex-US 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 ResponsibilitiesInteract 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 cross-functional 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 ex-US 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.Ideal CandidateBS/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 cross-functionally.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%.The anticipated salary range for candidates for this role will be $120,000-$140,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.What We OfferA great culture, grounded in our C.O.R.E. values:
C aring,
O riginal,
R esilient and
E goless.Opportunity to work in a fast-paced, 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, one-week company-wide shutdowns each year.Commitment to growing you professionally and providing access to resources to further your development.Apogee offers regular all team, in-person meetings to build relationships and problem solve.E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify.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.
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