Senior Associate, Regulatory Affairs

🕒 vor 1 Monat

Jetzt Bewerben

Ähnliche Remote-Jobs finden

E-Mails für Remote-Jobs erhalten

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen

Apogee Therapeutics

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

💰 €149.000.000 Series B im 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics ist ein biopharmazeutisches Unternehmen im klinischen Stadium, das sich auf die Entwicklung neuartiger Biologika zur Behandlung von Entzündungs- und Immunerkrankungen konzentriert. Das Unternehmen zielt auf bedeutende Märkte in den Bereichen entzündliche und immunologische Erkrankungen ab, wie z. B. atopische Dermatitis, Asthma, chronisch obstruktive Lungenerkrankung, eosinophile Ösophagitis und andere verwandte Zustände. Apogee Therapeutics strebt an, den aktuellen Behandlungsstandard zu verändern, indem es Antikörpertherapeutika vorantreibt, die auf etablierte biologische Mechanismen abzielen und das Potenzial haben, dermatologische, respiratorische und gastroenterologische Probleme zu adressieren. Das Unternehmen ist dazu verpflichtet, ein psychologisch sicheres Arbeitsumfeld zu schaffen, während es innovative Behandlungsoptionen für Menschen mit diesen Erkrankungen priorisiert.

Beschreibung

• Data steward of regulatory data in the RIM system (e.g., enter, update, and maintain), ensuring accuracy, completeness, and timeliness • Create, archive, and maintain regulatory submissions, Health Authority correspondence, and Health Authority commitments within the RIM system, in accordance with internal standards • Maintain submission trackers, timelines, track submission history and Health Authority commitments to ensure visibility into milestones • Coordinate with cross-functional teams and Regulatory Operations to support US submission planning, compilation, and timely delivery of regulatory documentation • Support preparation and organization of regulatory submission components (e.g., INDs, CTAs, amendments) • Perform QC activities (including eCTD QC for US submissions, as appropriate) to ensure completeness, consistency, and technical readiness • Support inspection readiness activities (e.g., TMF health checks, document completeness reviews) • Support department meetings and cross-functional communication, including agenda development, coordination of materials, and documentation of outcomes

🎯 Anforderungen

• BS (or equivalent) in related scientific discipline • 2+ years of experience working in the pharmaceutical/biotechnology industry (regulatory affairs experience preferred) • Strong organizational skills, attention to detail, and ability to manage multiple tasks concurrently • Strong written and verbal communication skills to clearly convey operational considerations and collaborate effectively with internal and external stakeholders • Proven proficiency in MS Word, Excel, Power Point; SharePoint/Teams (preferred) • Experience working in Veeva Regulatory Information Management (RIM) platform and eCTD submissions (preferred) • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Position requires up to 10% travel including mandatory in-person attendance at All Hands meetings typically held twice per year.

🏖️ Vorteile

• 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 base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave • 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