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GRCD-0, Sr Specialist Regulatory CMC
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
- Provide end-to-end support for Annual Reports and Renewals for all products, e.g. planning of required activities, attend kick-off/ jour-fixe meetings, contribute to DSP and ensure timely collection of respective requirements and deliverables
- Update and review CMC specific documentation, incl. coordination with countries to compile local CMC variations
- Provides support to Senior Managers of GRA CMC Small Molecule Development by executing assigned tasks to support the creation of sections of CMC dossiers and submission documents. This can include the transfer of data from available technical source documents to support CMC dossier creation, creation of tables with batch data or stability data based on technical source documents, uploading of certificates like CoAs, GMP certificates, MIA, QP declaration, etc. to Veeva Vault.
- Ensures provision of high-quality input into CMC dossiers that meets company's and health authorities’ requirements in accordance with requirements pre-defined by the Senior Manager. Ensures timely provision of deliverables within agreed timelines and proactively communicates any potential delay to the Senior Manager to avoid any impact on overall project and submission timelines.
- Position will be working in a matrix organization cross-functional within GRA with extensive communication and collaboration with Senior Managers from GRA CMC Small Molecules Development. stakeholders from various functions within or outside Global Regulatory Affairs
- The role will support the resolution of complex tasks, under close supervision and guidance provided from the Senior Manager more experienced CMC personnel
Who you are:
- Degree in a Life Science or a related discipline, preferably MSc
- 5-6 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role Minimum 3 years of Global CMC regulatory experience
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by the Company. The Company uses the definition of “fully vaccinated” assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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