Über das Unternehmen:Für ein führendes Unternehmen im Pharmabereich suchen wir einen Regulatory Affairs Manager mit besonderem Schwerpunkt auf CMC (Chemistry, Manufacturing, and Controls) für Nicht-EU-Märkte. Diese Position richtet sich an Fachkräfte, die ihre Expertise in einem dynamischen und internationalen Umfeld einbringen möchten.Unser Kunde ist ein weltweit führendes Pharmaunternehmen, das innovative Produkte und Lösungen im Gesundheitswesen entwickelt und vermarktet. Mit einem starken Fokus auf Forschung und Entwicklung trägt das Unternehmen maßgeblich zur Verbesserung der globalen Gesundheitsversorgung bei. Aufgabenbereich:Verantwortung für die Erstellung und Einreichung von CMC-Dossiers für Nicht-EU-Märkte unter Berücksichtigung globaler regulatorischer Anforderungen.Erstellung und Betreuung von Zulassungsdossiers mit internationalen Partnern.Bearbeitung von Verlängerungen und Änderungsverfahren.Koordination von Mängelbescheiden und Einreichungen.Überwachung der regulatorischen Compliance.Pflege der pharmazeutischen Dokumentation (Modul 3, QOS) im e-CTD-Format.Bewertung und Nachverfolgung von Änderungen (Change-Control). Anforderung:Naturwissenschaftliches Studium oder vergleichbare Qualifikation (Chemie, Biologie, Pharmazie)mind. 2 Jahre Berufserfahrung im Bereich Regulatory Affairs, insbesondere im CMC-Bereich & non-EU.Fundierte Kenntnisse der regulatorischen Anforderungen für Nicht-EU-Märkte.Erfahrungen in Zulassungsverfahren mit bestehenden Zulassungen und Erstzulassungen-DocuBridge Erfahrung von Vorteil.Deutsch fließend in Wort und Schrift (mind. B2); Englisch (mind. B2)Teamorientierte Arbeitsweise. Wichtige Informationen:Vollzeit, unbefristete Position (40 h)Arbeiten in einem hochinnovativen und zukunftsorientierten Unternehmen.Möglichkeiten zur beruflichen Weiterentwicklung in einem internationalen Umfeld. Ihre Vorteile:Flexible Arbeitszeiten und mobiles Arbeiten.Attraktive Benefits wie Hansefit, Jobrad, Deutschlandticket und Kindergartenzuschuss.Umfassendes Onboarding mit Mentoring-Programm.Individuelle Weiterbildungsmöglichkeiten.Internationales, wachsendes Familienunternehmen mit kurzen Entscheidungswegen.

Regulatory Affairs CMC Manager (m/f/x)- Bayern, Germany We are seeking a Senior Regulatory Affairs CMC Manager to join one of our key client's team as a quality expert. This role involves providing expertise on a broad range of drug substances (small molecules, biologicals). The position covers quality-related topics from pre-clinical development through to approved commercial products. Key Responsibilities:Quality aspects of drug development and regulatory requirements, collaborating with cross-functional team experts.Ensure CMC work-packages and documentation are phase-appropriate, meet regulatory expectations, and support regulatory submission approvals.Prepare quality sections for MAA, BLA/NDA, IMPD, and IND.Analyses, identify critical CMC development issues, and develop resolution strategies.Support due diligence processes.Manage operational and strategic aspects with CDMOs.Coordinate filing activities within the cross-functional team and with contributing parties.Stay up to date with regulatory guidance and regulations. Qualifications:Ph.D. or master's degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a related field.Minimum of five years in a scientific/technical CMC development or CMC regulatory affairs role.Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).Excellent communication and negotiation skills in English; German is a plus.Familiarity with CMC and regulatory requirements from pre-clinical to Phase III or commercial stages.Strong team player with excellent interpersonal skills.Proficient in Microsoft Office applications. Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application! Email: s.revesz@sciproglobal.deTel: 0049 (0) 89 26 200 311 (direct dial)LinkedIn: www.linkedin.com/in/sara-revesz-1938b2239

Overview A top mid-sized biopharma company out of the Boston area is hiring for a Director of Clinical Pharmacology. This position is can provide remote flexibility. This company is global biotechnology company with multiple commercialized drug products in the U.S and a great reputation in the space. This company operates in a few different therapeutic areas and requires a senior member to join their clinical pharmacology team and lead strategic decision making to develop their clinical pipeline. You will be acting as a SME in clinical pharmacology working with internal and external teams. You will be using the model informed drug development paradigm to facilitate drug development. As well as providing input to all applicable clinical development plans, protocols, and clinical study reports. You will work on regulatory submissions and represent Clinical Pharmacology at meetings with regulatory agencies. This individual will also help develop strategy to streamline processes in the Clinical Pharmacology group. What would you be doing? Serve as a Clinical Pharmacology SME for early development and late stage clinical projects. Provide guidance on lead modalities and programs to various teams working to determine the right target, molecule, dose, patient population and strategies. Apply knowledge in PKPD and relevant analysis (experience reviewing datasets in R or NONMEM is a plus) to strategize and predict exposure-response as well as dosing. Working closely with multiple different cross functional teams such as PMX to develop study protocols (Phase I – III). Advise on various regulatory documents (INDs, IBs, CDTs). Collaborate with various regulatory agencies (FDA, EMA, PMDA). Requirements: PhD required in pharmaceutical sciences, pharmacology, or related field At least 8+ years in the biotechnology or pharmaceutical industry Experience with clinical pharmacology and PKPD modeling, exposure-response or dose selection Experience with clinical PK data and data analysis (Phase I-IV) Experience in NONMEM and/or R (nice to have) Excellent communication skills