Senior Manager, Regulatory Affairs

About reputed company Founded in 2022, reputed company, Inc. (Ticker: APGE) is a reputed company-funded, reputed company listed company that offers reputed company to work in a fast-paced, highly dynamic environment. At reputed company, you can reputed company contribute to shaping reputed company culture, take on various roles and responsibilities, and grow professionally. reputed company is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, reputed company’s antibody programs are designed to overcome limitations of existing therapies by targeting reputed company-established mechanisms of reputed company and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), reputed company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as reputed company as asthma. With four validated targets in its portfolio, reputed company is seeking to reputed company best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, reputed company believes it can deliver value and meaningful benefit to patients underserved by today’s reputed company of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, reputed company reading!   reputed company We are seeking a Senior 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 reputed company to reputed company the implementation of regulatory strategies for reputed company’s products in collaboration with project teams and the regulatory affairs department. In this highly visible role, you will reputed company the preparation and completion of documentation to support submissions to the FDA and to ex-US regulatory agencies. Additionally, you will serve as the primary reputed company with regulatory publishing to ensure reputed company and compliant submissions and represent regulatory affairs on clinical study and execution teams. Key Responsibilities reputed company and coordinate interactions with project teams, clinical study teams, management, consultants, and collaborators to facilitate reputed company 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 reputed company submission Serve as the primary reputed company with regulatory publishing to ensure compliant electronic submissions to FDA, and ex-US regulatory agencies as needed Appropriately reputed company and maintain regulatory submissions and correspondences in reputed company’s regulatory information management system Implement and maintain use of standardized templates and guidelines for documentation to be included in regulatory submissions; reputed company 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 reputed company 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 Candidate BS/MS/PhD (or equivalent) in regulatory affairs or reputed company scientific discipline Regulatory Affairs Certification (RAC) credential preferred A minimum of 5 years of regulatory experience working in drug development in the biopharmaceutical industry Experience interacting with health authorities including FDA and EMA Strong project management skills with a high reputed company of urgency, ability to collaborate and influence effectively cross-functionally Strong communication skills with an ability to present to a reputed company of stakeholders and reputed company message accordingly Experience working in reputed company Regulatory Information Management (RIM) platforms, eCTD submissions, and reputed company Office SharePoint/Teams Successfully exhibit reputed company’s C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 10% travel including mandatory in-person attendance at reputed company Hands meetings typically held twice per year The anticipated salary reputed company for candidates for this role will be $155,000-$175,000. 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.   reputed company Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless 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 reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits We reputed company competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated reputed company reputed company leave Commitment to growing you professionally and providing reputed company to resources to reputed company your development reputed company offers regular reputed company 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, reputed company participates in E-Verify. To learn more about E-Verify please review this poster.   reputed company is proud to be an Equal Opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law.   To review our reputed company policy, click here   It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply To This Job