Regulatory Affairs Specialist - Medical Devices (m/f/x) | hybrid They commitment to precision and innovation, combined with the scientific expertise of experienced industry professionals, has allowed them to build a strong reputation and establish they products with an international clientele. As part of they team, you'll have the opportunity to contribute to groundbreaking advancements in reproductive healthcare, working in a dynamic environment where quality and excellence are at the forefront. What are your responsibilities as a " Regulatory Affairs Specialist (m/f/x)"?Manage regulatory submissions for medical devices, ensuring compliance with MDR (Medical Device Regulation) and other relevant standards.Prepare, review, and submit technical documentation, ensuring products meet regulatory requirements.Serve as the primary contact with regulatory authorities, handling queries and negotiations.Monitor changes in regulations and ensure timely implementation of new requirements across all relevant departments.Collaborate with cross-functional teams, including R&D, Quality Assurance, and Product Management, to ensure product compliance.Provide regulatory guidance during product development and lifecycle management. What requirements should you bring as a "Regulatory Affairs Specialist (m/f/x)"?A minimum of 3 years of professional experience in Regulatory Affairs within the medical technology or medical devices industry.In-depth knowledge of EU Regulation 2017/745 or 746, as well as other regulatory frameworks, is essentialUniversity degree in a relevant field such as Life Sciences, Engineering, or a related discipline.Experience preparing technical documentation and managing submissions to regulatory authorities.Excellent communication skills and ability to work with cross-functional teams.Fluency in both German and English. What does the company offer you? Contract type: Permanent full-time contract.Vacation: 27 days/yearHome office: Up to 40% remote/mobile.Working hours: 40 hours/week.A dynamic work environment with a flat organizational structureOpportunities to quickly take on responsibility and make a meaningful impactStart date: As soon as possible My contact details:Email: m.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/ Are you interested in this position? Then you should apply now! If you desire additional or alternative job opportunities, I also welcome your application. I look forward to receiving your application!

Junior 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 "Junior 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 " Junior 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!

Manager - Regulatory Affairs CMC (m/f/x) | Bayern | Pharma In this role, your primary responsibility is to support the Regulatory Affairs team for one of our key clients. If you are motivated and enjoy working on exciting projects and innovative products, don't hesitate to apply! What will your tasks as "Manager - Regulatory Affairs CMC (m/f/x)" be?Creation, organization, and administration of documents (particularly CMC documentation/US "Micro package"QM system and validation summaries, statements/confirmations) for national and international regulatory projects.Preparation of CTD modules and conduct of CTD reviews.Submission/receipt of Site Accreditation/Site Registration.Assessment/responding to customer and regulatory authority inquiries regarding Regulatory Affairs topics. Your requirements as a "Manager - Regulatory Affairs CMC (m/f/x)"?Successfully completed a scientific degree (e.g., Pharmacy, Biology, Chemistry, Food Chemistry), BSc, MSc, MDRA.Several years of professional experience/knowledge in drug approval (national, EU, global). Knowledge of GMP compliance is advantageous.Experience in Regulatory Affairs CMC.Several years of experience in preparing CMC dossiers.Prior experience with tech transfer processes and knowledge in Regulatory Affairs Intelligence is a plus.Strong communication and team skills.Ability to work independently with high dedication.Excellent communication skills, confident demeanor, motivation, team spirit, and assertiveness.High scientific methodological competence combined with customer orientation.Excellent German and English language skills. Information about our client:The company is one of the largest pharmaceutical companies in the world who operates globally in European and non-European countries. Our client is known for having a portfolio of around 20 well-known pharmaceutical products and for their constant growth within the industry. Application process:CV to my email: revesz@sciproglobal.deCall with a presentation of the companyI am your contact person for the entire application process (interviews to contract negotiations) i.e. You don't have to apply yourselfDiscuss other exclusive positions that are tailored to your profile My contact details:Email: revesz@sciproglobal.deTel: +49 89 26200311 (direct dial)LinkedIn: linkedin.com/in/sara-revesz-1938b2239 I look forward to your application!

Vice President Global Head of Safety REMOTE Competitive Compensation Package Based on Experience Base + Annual Bonus + Stock Options   SciPro Global is partnered with an exciting Clinical Stage Immuno-Oncology Biotech that is gearing up for an NDA in the US, while they have 10 approved products Globally. In preparation for this, they're looking to bring in a Head of Safety to lead Safety Strategy, as well as the overall Safety department. With a strong owned pipeline, and a growing partnered pipeline too, this biotech has plenty of stability and potential.   Responsibilities include (but not limited to): Leading Safety Strategy for entire pipeline of products. Driving the safety strategy during NDA/BLA submission. Building a strong Safety team. Safety operations oversight. Hands on Safety Science work as needed such as aggregate reports, signal detection, benefit risk assessment. Responding to health authority queries regarding safety & risk sections of regulatory documents. Cross functionally act as Safety SME for assigned products & liaise with other Clinical counterparts across the organization. Communicate safety updates with external & internal stakeholders. Provide safety input for clinical study design activities. Identify ways of improvement for team & safety group.   Requirements include (but not limited to): Medical Doctor or Foreign Equivalent Oncology Experience required. Management experience. Experience leading a Safety department. Solution Oriented mindset & motivated!   Are you looking to join a brand name company to grow your career?   Apply now to begin the process!

Regulatory Affairs Consultant Remote (AUS) - Contract This company is a well-funded biotech firm specializing in the development and delivery of advanced therapies for cancer patients. Their leading-edge research and development focus on providing novel, life-saving therapies for patients with various forms of cancer, striving to improve outcomes and quality of life. Qualifications/Respoonsibilities: Experience filing and aiding in DGA discussions Experience with filing BLA/MAA Scope of the role includes DGA interactions, module 1 (reviewing/updating administrative work) Guide the team through strategic discussions with DGA Provide gap assessment for submissions Experience with biologics, oncology experience (cell therapy preferred)