Regulatory Affairs Cmc Associate Manager

Vor 7 Tagen


Basel, Basel-Stadt, Schweiz SimplyVision GmbH Vollzeit
For our customer located in Basel/Switzerland we are currently looking for a
:Regulatory Affairs CMC Associate Manager (M/F/x)**-

pay rate range - given by our client: 51 chf/h*Hiring Manager Job Description:

  • As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of high quality CMC regulatory documentation for our products and contribute to global regulatory submissions and strategies.

Tasks & Responsibilities

  • Author highquality global CMC documentation for regulatory submissions throughout the product lifecycle for Biologics projects/products.
  • Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Coordinate, collect, store source documentation needed for direct submission to Health Authorities.
  • Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.

Must Haves

Experience

  • Experience in regulatory and/or in the pharmaceutical industry preferred
  • Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.
  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of the drug development process desirable.

Requirements:

  • Education
  • Degree in Science (e.g. Biochemistry, Biology, Biotechnology, Chemistry, Pharmacy) or equivalent. Advanced Degree in Science desirable
  • Good oral and written communication skills with a collaborative and patientfocused mindset
  • Ability to work successfully with global project teams and prioritize activities considering timelines and workload
  • Welldeveloped planning, organizational, negotiation, problem solving and interpersonal skills
  • Computer/IT systems literacy
Did we catch your interest?

  • Basel, Basel-Stadt, Schweiz Source Group International Vollzeit

    Posted: Today Location: Basel, Switzerland Job Ref: BH Job Type: Contract Salary:CHF40 CHF44 per hourExpiry date: 1/18/2023 Contact:Audwin CheungXplore Life Sciences are recruiting for an Associate Regulatory Affairs CMC Manager to work for a Global Leader in Pharmaceuticals based in Basel.This is an 18 Month freelance contract and you must have valid right...


  • Basel, Basel-Stadt, Schweiz Manpower Suisse Vollzeit

    For our client, a leading pharma company in Basel, we are looking for a Regulatory Affairs CMC Associate Manager to start asap.Contract duration: 18 months with extension possibleWorkload:100%Location: Basel cityDescription:As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of high-quality CMC (Chemistry,...


  • Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Regulatory Affairs Manager CMCFor our client in Basel, we are looking for RA CMC Manager who will be responsible for global CMC submission activities for assigned projects.Responsibilities: Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source...


  • Basel, Basel-Stadt, Schweiz SimplyVision GmbH Vollzeit

    For our customer located in Basel/Switzerland we are currently looking for a: Regulatory Affairs CMC Manager (M/F/x)Tasks & Responsibilities / Must Haves Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health...


  • Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career NetworkOur client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for an Regulatory Affairs CMC Manager for 18 month contract role based in Basel, Switzerland.As Associate Manager within our Global Regulatory Affairs CMC team, you support timely...


  • Basel, Basel-Stadt, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Regulatory Affairs Manager - CMC for a pharmaceutical organisation. This role is on a contract basis and is located in Basel.***Responsibilities: Offer regulatory assistance for projects and project teams. Write, evaluate and offer contribution from a CMC perspective on pertinent documents necessary for clinical (IND/IMPD) and...


  • Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career NetworkOur client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading...


  • Basel, Basel-Stadt, Schweiz Moderna Vollzeit

    The Role:Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...


  • Basel, Basel-Stadt, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...


  • Basel, Basel-Stadt, Schweiz Hobson Prior Vollzeit

    Hobson Prior are collaborating with a brilliant pharma establishment who are currently looking for an individual to join their team on a permanent basis located in either Basel or Stockholm. Our client is focused on offering novel remedies that will transform the lives of those suffering from rare illnesses. Th opening position is for a Global regulatory CMC...


  • Basel, Basel-Stadt, Schweiz Stratpharma Vollzeit

    Stratpharma, a fast-growing Dermatology company, is currently looking for a Global Regulatory Affairs Associate to join their dynamic team. This is an exciting opportunity to be part of a company that is experiencing rapid growth and expanding globally.This is a highly successful company who have an impressive 200% year on year growth and are going through...


  • Basel, Basel-Stadt, Schweiz ProClinical Vollzeit

    Salary:Highly CompetitiveJob type:PermanentDiscipline:Project ManagerLocation:Switzerland- Basel, Schweiz Posting date: 27 Feb 2024Reference:57992Proclinical are recruiting for a Regulatory Affairs Manager - EMEA to join a pharmaceutical organisation. This role is on a permanent basis and is located within the EMEA with the ability to either work remotely or...


  • Basel, Basel-Stadt, Schweiz Moderna Vollzeit

    The Role:Here's What You'll Do:Provide leadership for regulatory CMC aspects of product development projectsLead and drive all CMC submission activities (planning,Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelinesDevelop effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA)...

  • Cmc Dossier Manager

    Vor 7 Tagen


    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.CMC Dossier Manager:Role &...


  • Basel, Basel-Stadt, Schweiz Bernwald Personalberatung GmbH Vollzeit

    Unsere Mandantin ist ein Schweizer KMU, das sich in einer Nische im Pharmabereich erfolgreich etabliert hat.In ihrem Auftrag suchen wir eine Persönlichkeit mit ausgeprägtem Verantwortungsbewusstsein als Regulatory Affairs Manager Pharma EU/CH (m/w/d).**Arbeitsort**: Grossraum ZürichAufgaben- Selbständiges Erstellen von CMC-Zulassungsdokumentationen-...


  • Basel, Basel-Stadt, Schweiz Stratpharma AG Vollzeit

    Stratpharma, a fast-growing Dermatology company, is currently looking for a Global Regulatory Affairs Associate to join their dynamic team. This is an exciting opportunity to be part of a company that is experiencing rapid growth and expanding globally.This is a highly successful company who have an impressive 200% year on year growth and are going through...


  • Basel, Basel-Stadt, Schweiz unisite AG Vollzeit

    Die Gesundheit und die Lebensqualität von Patienten zu verbessern, ist das Ziel des forschenden Pharmaunternehmens Boehringer Ingelheim. Seit der Gründung im Jahre 1885 in Familienbesitz, zählt Boehringer Ingelheim zu den 20 führenden Unternehmen der Branche. Für die drei Geschäftsbereiche Humanpharmazeutika, Tiergesundheit und Biopharmazeutika...


  • Basel, Basel-Stadt, Schweiz Stratpharma AG Vollzeit

    Stratpharma, a fast-growing Dermatology company, is currently looking for a Global Regulatory Affairs Associate to join their dynamic team. This is an exciting opportunity to be part of a company that is experiencing rapid growth and expanding globally.This is a highly successful company who have an impressive 200% year on year growth and are going through...


  • Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Cmc Dossier Manager

    Vor 7 Tagen


    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    CMC Dossier ManagerThe CMC Dossier Manager works in the Sobi Technical Operations Department within in the CMC Program Management unit. The role is responsible for technical oversight and the coordination of generation of CMC documentation. Within the scope is the source documentation for process development, process validation, GMP and non-GMP manufacture...