Regulatory Affairs Director of Cmc

Vor 6 Tagen

Berlin, Deutschland Hobson Prior Vollzeit

Hobson Prior are currently seeking for a Regulatory Affairs Director of CMC to join a brilliant pharmaceutical organisation on permanent basis with the ability to work across various sites in Europe. Our client is focused on providing the best possible remedies to protect the health and wellbeing of people.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- For this role you will be guiding interactions with health agencies to approve on CMC regulatory methods and data needs to enable successful approval of allocated products/projects.
- Participate in CMC process initiatives to assist in the production of internal international and local SOPs and guidance papers.
- Offer training and direction to less experience personnel in the EU CMC regulatory team.
- You will anticipate when and how regulatory problems may influence the business and conscientiously and swiftly advice project teams and management appropriately.
- Any other assigned duties.

**Requirements**:

- Familiarity with small molecule dosage forms as well as with biological products which would be beneficial for the role.
- Comprehension of eCTD needs and familiarity with planning CMC documentation for new product EU MAAs such as Module 3, Module 2 QOS, Module 1 Quality connected administrative documents, etc.
- Prior involvement in writing post-approval variations for CMC alterations.
- Know-how of EMA and ICH regulatory CMC/Quality regulations suitable across the product life cycle.
- Experience with age-suitable paediatric construction needs and assisting in planning CMC sectors for PIPs.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Berlin, Berlin, Deutschland Terumo Europe, Middle East & Africa Vollzeit 50.000 € - 80.000 € pro Jahr

    At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you'll grow your expertise while staying true to your personal aspirations.  Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading;...

  • Cmc Specialist

    Vor 6 Tagen

    Berlin, Deutschland Bausch + Lomb Vollzeit

    The Global Regulatory CMC Bausch + Lomb team plays a critical role as part of the strategy for Bausch Health. For this reason, we are currently recruiting for one CMC Specialist (M/F/x) with Polish language skills **Purpose**: Timely preparation and update of pharmaceutical Chemistry, Manufacturing & Control (CMC) documentations for medicinal products with...

  • CMC Director

    Vor 6 Tagen

    Berlin, Berlin, Deutschland WuXi Biologics Vollzeit 80.000 € - 120.000 € pro Jahr

    Summary:Oversight of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team. The position will also participate in business development activities such as visiting clients and promoting WuXi Biologic's services at conferences/trade shows.Responsibilities:Provide technical and...

  • Regulatory Affairs Coordinator

    vor 1 Woche

    Berlin, Deutschland JobMatchingPartner Vollzeit

    We have been entrusted with finding the right person for an interesting and perhaps a little unusual role, based in Berlin, Germany. Our client is a Sportsbetting operator, licenced in Germany and Austria. Reporting directly to the Managing Director, the **Regulatory Affairs Coordinator** will be responsible for overseeing the coordination of the...

  • Clinical & Regulatory Affairs Specialist

    vor 15 Stunden

    Berlin, Deutschland Meditrial Europe Ltd. Vollzeit

    **Company Overview**: Meditrial is a dynamic and rapidly growing multinational company specializing in providing clinical and regulatory services to medical device companies in the USA and Europe. With a commitment to excellence and innovation, we empower our clients to navigate complex regulatory landscapes and bring life-changing medical devices to market...

  • Gruppenleiter Cmc

    vor 1 Woche

    Berlin, Deutschland MCM Klosterfrau Vertriebsgesellschaft mbH Vollzeit

    Wir sind ein unabhängiges und traditionsreiches Unternehmen. Die Qualität unserer Mitarbeiter, ihre Motivation und ihr Engagement sind zentraler Bestandteil unseres Unternehmenserfolges, der uns in zu einem führenden Anbieter bei der Selbstmedikation in Deutschland macht. Wir suchen Sie als Gruppenleiter (m/w/d) CMC (Chemistry Manufacturing...

  • Biocidal Team Leader

    Vor 7 Tagen

    Berlin, Deutschland Staphyt Vollzeit

    Staphyt veille au respect de l'égalité femmes/hommes : Cliquez ici pour télécharger l'index d'égalité femmes/hommes pour Staphyt FranceAt Staphyt, our Regulatory Affairs Division helps clients navigate complex regulatory environments and successfully bring their chemical or biological substances and products to market. We support projects across Plant...

  • Regulatory Affairs Manager

    vor 1 Woche

    Berlin, Berlin, Deutschland LGC Vollzeit 60.000 € - 80.000 € pro Jahr

    UnternehmensbeschreibungWerde Teil von Axolabs – Wo Innovation auf Wirkung trifft im Bereich RNA-TherapeutikaBei Axolabs arbeitest du in einem internationalen Team, das wegweisende Fortschritte in der Entwicklung von Nukleinsäure-basierten Arzneimitteln erzielt – von der computergestützten Wirkstoffentwicklung über Hochdurchsatz-Screening bis hin zur...

  • Regulatory Affairs Manager

    vor 1 Woche

    Berlin, Berlin, Deutschland LGC Group Vollzeit 50.000 € - 80.000 € pro Jahr

    Unternehmensbeschreibung LGC Standards ist ein Unternehmensbereich der LGC Group, dem britischen National Measurement Institute für chemische und bioanalytische Messungen. Wir sind ein weltweit führendes Herstellungs- und Dienstleistungsunternehmen von Qualitätssicherungs- und Forschungsinstrumenten, die den analytischen Bedarf in mehr als 120 Ländern...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Berlin, Berlin, Deutschland LGC Group Vollzeit 60.000 € - 85.000 € pro Jahr

    Unternehmensbeschreibung Werde Teil von Axolabs – Wo Innovation auf Wirkung trifft im Bereich RNA-TherapeutikaBei Axolabs arbeitest du in einem internationalen Team, das wegweisende Fortschritte in der Entwicklung von Nukleinsäure-basierten Arzneimitteln erzielt – von der computergestützten Wirkstoffentwicklung über Hochdurchsatz-Screening bis hin zur...