Senior Manager RA CMC (LCM)

☞ Hobson Prior

Aussicht: 110

Update Tag: 22-04-2024

Ort: Nyon Vaud VD

Kategorie: Der Umsatz

Industrie:

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Jobinhalt

Salary:

CHF140000 - CHF150000 per annum

Job type:

Permanent

Location:

Nyon, Schweiz

Function:

Regulatory Affairs, CMC
Posted:04/01/2024

Ref:

BBBH24249
Hi I’m
Syem
, I manage this role

Hobson Prior are currently seeking for a Senior Manager RA CMC (LCM) to join a fantastic healthcare organisation on a permanent basis located in Nyon. Our client is focused on developing life-saving treatments and devices.

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

Key Responsibilities:

  • Responsible for translating agency queries in regulatory CMC positioning, to produce an understanding story line and CMC replies.
  • You will serve as the regulatory affairs CMC lead for roll out actions and LCM.
  • Engage with the regional regulatory group and country contacts linking to proposal planning, timelines for replies and notify them about upcoming alterations to the product that lead to variations.
  • Accountable for engaging with CMC teams and site representatives for preparing response to queries and specific CMC documentation requests.
  • For this role, you will handle preparing CMC linked documents, CMC regulatory data allocated role out and LCM actions.
  • Implement the CMC RA method for allocated products.
  • Handle the CMC regulatory actions and CMC proposal method of reports and proposals that best serve the business requirements and guarantee compliance with the regulatory systems.
  • Any other assigned duties.

Requirements:

  • Acquaintance with engaging with regulatory agencies.
  • Familiarity with biological development.
  • Educated to a degree level in a life science or similar field though an advanced degree would be more ideal.
  • Demonstrable experience in regulatory affairs CMC.
  • Familiarity with handling global regulatory proposals, BLA/MAA or variations.
  • Fluency in the English language though knowledge in a second language would be beneficial.
  • Communication skills both verbally and in writing.
  • Interpersonal abilities.
  • An organised individual with the ability to plan appropriately.
  • A high attention to detail.
  • Works well in teams.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

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.

By providing your details and submitting this form, you confirm you have read and understood our privacy policy. We only share your personal details with our group companies at
acaciumgroup.com/affiliates
and those categories of third parties in our privacy policy at
hobsonprior.com/privacy-policy
.
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Frist: 06-06-2024

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