Director Regulatory Affairs CMC San Francisco, CA (Hybrid) 6 month initial contract (likely extension and conversion to FTE) This client is a clinical-stage precision oncology biotech focused on creating cutting-edge therapies to target cancer treatments. Responsibilities: Develop and implement CMC regulatory strategies to facilitate the clinical development and eventual marketing approval of investigational products Oversee the creation and upkeep of the PDM and quality sections for regulatory submissions, including initial IND, IMPD/CTA, NDA, MAA filings, and amendments, as well as preparing responses to inquiries from Health Authorities (HAs) Act as the PDM regulatory representative on project teams, offering CMC regulatory support to ensure compliance with relevant regulatory requirements during the clinical development of investigational products Collaborate with the corporate regulatory team, CMC subject matter experts, and/or CROs to identify regional and country-specific CMC requirements, driving PDM submission timelines to achieve business objectives Engage with the FDA and other global regulatory bodies as needed. Provide regulatory assessments and guidance on PDM-related change controls, deviations, and investigations throughout the product lifecycle Requirements: Preferably an advanced degree (MSc or PhD) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a related field is preferred The candidate should have over 12 years of experience in pharmaceutical/biotech drug development, including more than 4 years in global CMC regulatory affairs, with expertise in PDM development for NCEs/small molecules They should have a proven track record in leading global PDM-related submissions (IND, IMPD/CTA, NDA, MAA, etc.) A deep understanding of US and international GMP quality regulations, current industry practices, and the ability to interpret and apply these to development projects and regulatory issues for marketed products is essential.

SciPro has partnered with an exciting and fast-growing global business where innovation meets impact! As a collaborative force, experts in inhalation technology and oral delivery systems are looking to revolutionize healthcare, addressing unmet patient and consumer needs.On a mission to impact wellness and healthcare management, we are supporting them on their search for a Global Head of Clinical Development, VP. In the role, you'll lead strategic planning and execution of global clinical development programs, ensuring operational excellence and fostering cross-functional collaboration.With a track record of success in pharmaceutical leadership and a passion for making a difference, you'll thrive in the dynamic environment of a company at a stage of transformation. If you want to be part of shaping the future of healthcare whilst unlocking your own career growth opportunities, this is the role for you!Key Responsibilities:Build and effectively lead the Global Clinical Operations department.Represent the Global Clinical Operations as a part of the company's Corporate Leadership and Strategy Teams.Foster a culture of motivation, collaboration and inspection readiness.Strategically lead clinical development plans and drive successful implementation.Key Requirements:Experience with major regulatory bodies - FDA and EMA requirementsFinancial acumen to create and manage clinical budgetsExcellent negotiation skillsExperience in drug development across multiple therapeutic areas

Manager - Regulatory & Medical Writing (m/f/x) | Freiburg / hybrid Unser Kunde ist ein familiengeführtes Pharmaunternehmen, das sich auf innovative Arzneimittel im Feld der Gastroenterologie und Hepatologie fokussiert hat. Mit den bestmöglichen Therapien versucht das Unternehmen, die Sicherheit in Alltagssituationen von Betroffenen mit chronischen Darmerkrankungen sowie Stoffwechselprobleme, zu ermöglichen. Welche Aufgaben haben Sie als "Manager - Regulatory & Medical Writing "? Übernahme der Gesamtverantwortung für die Erstellung verschiedener wissenschaftlicher und regulatorischer Dokumente, einschließlich der wissenschaftlichen und inhaltlichen Bewertung sowie der Abstimmung mit Fachabteilungen.Verantwortung für die Erstellung wissenschaftlicher und regulatorischer Dokumente, einschließlich präklinischer und klinischer Module, Orphan Drug Designations, PIPs und Briefing-Dokumente.Regulatorische Betreuung von Entwicklungsprojekten, Fokus auf präklinische und klinische Fragestellungen, PIPs, Orphan Designation und Scientific AdviceZusammenarbeit mit globalen Vertriebspartnern und Tochterunternehmen weltweit bei Neuzulassungen und Lifecycle-Management.Koordination und Umsetzung regulatorischer Tätigkeiten im Pharmakovigilanz-Bereich, z. B. PSUR-Einreichungen.Regulatorische Unterstützung bei Ein- und Auslizensierungsaktivitäten und Entwicklung von Zulassungsstrategien.Company Core Data Sheets (CCDS) o Darauf basierend Erstellung und Aktualisierung der Produktinformationstexte für regulatorische Prozesse (Neuzulassungen, Variations, Renewals etc.)Regulatorische Unterstützung bei Ein- und Auslizensierungsaktivitäten (Due Diligence) und bei der Entwicklung von Zulassungsstrategien Welche Anforderungen sollten Sie als " Manager - Regulatory & Medical Writing " mitbringen? Studium der Pharmazie, Humanmedizin oder in den NaturwissenschaftenLangjährige Berufserfahrungen im Bereich Regulatory Affairs, idealerweise min. 7 JahreErfahrungen als Regulatory Medical Writer (Module 2.5. & 2.7.), sowie Erstellung von PIPsErste Erfahrungen mit Zulassungsverfahren in den USAFundierte Kenntnisse der medizinischen NomenklaturGute Kommunikation - und PräsentationsfähigkeitenTeamfähigkeit und FlexibilitätFließend in Englisch und DeutschFormularbeginn Was bietet Ihnen das Unternehmen?Vertragsart: unbefristeter VollzeitvertragUrlaub: 30 Tage / Jahr + ZusatzurlaubHomeoffice: up to 60% remote / mobilArbeitszeiten: 40 Stunden / WocheZugang: Parkplätze vor Ort und sehr gute Anbindung an öffentliche VerkehrsmittelStarttermin: So bald wie möglich Meine Kontakdaten:Email: inderhees@sciproglobal.deTel: 0049 (0) 89/26 20 09 25 (direct dial)Xing: https://www.xing.com/profile/Marlene_Inderhees/cvLinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/ Sind Sie an dieser Stelle interessiert? Dann sollten Sie sich jetzt bewerben! Wenn Sie weitere oder alternative Stellenangebote wünschen, freue ich mich auch über Ihre Bewerbung!Ich freue mich auf Ihre Bewerbung!

Senior Clinical Regulatory Affairs Manager (m/f/x) | Bavarian | PharmaIn a dynamic and collaborative environment, this role supports multidisciplinary teams focused on groundbreaking drug development, including small molecules, biologicals, and advanced therapies. This role spans the entire development lifecycle, from initial research to final approval processes.What will your tasks as "Senior Clinical Regulatory Affairs Manager (m/f/x)" be?Offering strategic regulatory advice to development teams.Overseeing clinical development within project teams.Crafting and implementing global regulatory development strategies.Managing interactions with global regulatory agencies. Your requirements as a "Senior Clinical Regulatory Affairs Manager (m/f/x)"?Master's degree in Life Science or Medicine or veterinary medicine10 years of experience in the pharmaceutical industryHands-on experience in strategic clinical development and regulatory strategy.Experience with multiple pharmaceutical companies and/or regulatory authorities is preferred.Capable of working independently, managing multiple tasks, and prioritizing under time constraints.Familiarity with EU and US regulatory proceduresExcellent written and oral communication skills in English, German as a second language is a nice to have What does the role as "Senior Clinical Regulatory Affairs Manager (m/f/x)" offer to you?Relocation support is available, including assistance with accommodationHybrid working model with 40-60% home office possibleOpportunities for professional growth by exposure to a wide range of innovative projects, focusing on expanding specialist skills rather than advancing to higher managerial levels.The role does not include client acquisition responsibilities. 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!My contact details:Email: inderhees@sciproglobal.deTel: +49 089 26 20 09 25 I look forward to your application!

Senior Medical Writer (m/f/x) | Bavaria |Pharma This role focuses on creating medical documentation throughout all development phases for small molecules, biologics, cell-based, and modern targeted/personalized therapies. What will your tasks as "Senior Medical Writer (m/f/x)" be?Set up medical documentation for all development phases of small molecules, biologics, cell-based, and modern targeted/personalized therapies.Develop and draft essential documents required during the clinical development stage, such as clinical study protocols, investigator brochures, clinical study reports, and publications.Draft a variety of high-quality regulatory documents needed for marketing applications, such as non-clinical and clinical summaries, clinical overviews, risk management plans, product information documents, and responses to inquiries from regulatory agencies.Perform strategic gap analyses of draft regulatory documents and clinical data packages and conduct critical literature searches to support and strengthen the messaging.Document and support agency meetingsPrepare documents aimed at expediting drug development and approval, such as Fast Track and Breakthrough DesignationGenerate additional documents as needed for specific projects, such as Orphan Drug Applications, Diversity Plans, and Pediatric Investigation Plans.Collaborate closely within cross-functional project teams, both internally and with clients. Your requirements as a "Senior Medical Writer (m/f/x)"?Master's degree in Life Science or Medicine or veterinary medicineExtensive experience in medical writing (preferably over 10 years) covering a wide range of regulatory documents.Thorough understanding of EMA, FDA, and ICH regulations and guidelines.Ability to work independently, analyze and summarize data (clinical, non-clinical, quality).Excellent written and oral communication skills in English, German as a second language is a nice to haveCapability to handle multiple tasks concurrently while meeting tight deadlines. What does the role as "Senior Medical Writer (m/f/x)" offer to you?Relocation support is available, including assistance with accommodationHybrid working model with 40-60% home office possibleOpportunities for professional growth by exposure to a wide range of innovative projects, focusing on expanding specialist skills rather than advancing to higher managerial levels.The role does not include client acquisition responsibilities.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!My contact details:Email: inderhees@sciproglobal.deTel: +49 089 26 20 09 25I look forward to your application!