Regulatory Affais and CMC technical writer consultant
Randstad AB / Civilingenjörsjobb / Stockholm
Observera att sista ansökningsdag har passerat.
Visa alla civilingenjörsjobb i Stockholm,
Solna,
Lidingö,
Sundbyberg,
Danderyd eller i
hela Sverige Visa alla jobb hos Randstad AB i Stockholm,
Solna,
Lidingö,
Sundbyberg,
Danderyd eller i
hela Sverige Job description
We are proactively seeking highly motivated and detail-oriented Regulatory Affairs and CMC Specialists to join our team at Randstad Life Sciences Stockholm/Södertälje.
As a consultant at Randstad Life Sciences, you will be employed by Randstad but work on-site at one of our prestigious client locations. Your daily workplace will be dynamic and challenging, offering opportunities for professional growth and development.
As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies within Life Science.
At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.
Responsibilities
Regulatory Submissions:
Prepare and submit CMC regulatory documents to health authorities, ensuring compliance with regional requirements.
Coordinate and support the preparation of Investigational New Drug (IND), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions.
Developing the technical eCTD sections to support Regulatory CMC dossier applications.
CMC Management:
Oversee and manage CMC strategies, ensuring alignment with regulatory requirements.
Collaborate with internal teams to develop and implement CMC plans for product development and commercialization.
Development of the Quality module.
Regulatory Compliance:
Stay current with evolving regulations and guidelines
Providing guidance to the organization on regulatory matters.
Conduct regulatory assessments to identify potential risks and develop mitigation strategies.
Qualifications
Bachelor's or advanced degree in a scientific or related field.
Minimum 1 years of experience in Regulatory Affairs and/or CMC.
Strong understanding of global regulatory requirements and guidelines.
Experience with regulatory submissions and interactions with health authorities.
Excellent organizational and communication skills.
Ability to work collaboratively in a fast-paced, dynamic environment.
Experience
Farmakologi
Reglering
Läkemedelsvetenskap
About the company
Randstad
At Randstad, we see the possible in people. With business all over Sweden and in all areas of expertise, we help people find work that feels good, where they get the opportunity to develop and realize their true potential. With close to 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry. Our mission is to become the world's most valued working life partner. By combining our passion for people with the power of today's technology, we support people and organizations in realizing their true potential. We call it Human Forward.
Ersättning Not specified
Så ansöker du Sista dag att ansöka är 2023-12-29
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Randstad AB (org.nr 556242-1718)
Arbetsplats Randstad
Kontakt Julia Grendler
julia.grendler@randstad.se +46704036701 Jobbnummer 8298692
Observera att sista ansökningsdag har passerat.