Ra Cmc Associate Manager

vor 1 Woche


Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

The Life Science Career Network


Our 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 preparation of high quality CMC regulatory documentation for our products and contribute to global regulatory submissions and strategies.


Main 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.

Qualifications and Experience:

-
_Swiss working/residency permit and/or Swiss/EU-Citizenship required; _:

  • Degree in Science (e.g. Biochemistry, Biology, Biotechnology, Chemistry, Pharmacy) or equivalent. Advanced Degree in Science desirable
  • 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.
  • 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

  • Ra Cmc Manager

    vor 1 Woche


    Basel, Basel-Stadt, Schweiz Hobson Prior Vollzeit

    Hobson Prior are looking for a RA CMC Manager to join a brilliant pharmaceutical corporation on a contract basis located in Basel. Our client is focused on improving and prolonging the lives of many.Please note that to be considered for this role you must have the right to work in this location.Key Responsibilities: For this position, you will be accountable...


  • 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...


  • 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 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...

  • Ra Cmc Manager

    vor 1 Woche


    Basel, Basel-Stadt, Schweiz Warman O'Brien Vollzeit

    A Regulatory Affairs CMC Manager is required to join a global pharmaceutical company based in Basel on an 18-month contract.What you will be doing: Support all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or...


  • 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...

  • Cmc Dossier Manager

    vor 1 Woche


    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 &...

  • Cmc Dossier Manager

    vor 1 Woche


    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...


  • 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.Head of CMC Program...


  • Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, there is more we can do to help improve and extend people's lives In Global Regulatory Affairs CMC, our work starts when a compound goes into clinical trials. Novartis has a unique and promising portfolio. All of these innovative projects are aimed at making a...


  • 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...

  • Head of Cmc

    vor 1 Woche


    Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    The RoleAs Head of CMC, you will ensure that late development and lifecycle plan are translated in sustainable reality. For this, you can rely on a team of CMC project lead and CMC dossier managers. They manage end to end complex technical CMC projects, including budget and reporting, CMC regulatory strategy and scientific writing. You will work closely with...


  • Basel, Basel-Stadt, Schweiz Aixial Group Vollzeit

    Senior Manager – CMC Dossier Manager (M/F) Location : Basel, Switzerland Who is Aixial Group ? Aixial Group, we are a CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market. Since 2014, we have been part of the Alten...


  • 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 Bayer Vollzeit

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...

  • Cmc Technical Writer

    vor 1 Woche


    Basel, Basel-Stadt, Schweiz Aixial Vollzeit

    Who is Aixial Group ?Aixial Group, we are a CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market.Since 2014, we have been part of the Alten family.We are developing our activities in Switzerland, France, Belgium, Czech Republic,...


  • 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 Sobi Vollzeit

    Drug Substance CMC LeadSobi 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.Key...