regulatory affairs manager in visp

publié:
lieu
visp, valais
secteur
life sciences
type d'emploi
temporaire
numéro de référence
9317
contact
mayank chaubey, basel professionals it & life sciences
téléphone
058 201 55 50
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description du poste

Our client, a big pharmaceutical located in northern part of Switzerland is currently looking for

Regulatory Affairs Manager

Location: Northern Switzerland

Contract: until 31.12.2017 (High possibility of extension)

Start date: ASAP

Job Description:

In the role the candidate will be responsible for the Regulatory submissions onsite. The candidate is required to have strong experience in regulatory submissions, minimum 5-8 years in, CMC Regulatory Affairs, Competent in Microsoft Office Software (Word, Demonstrated ability to manage priorities and work under tight timelines, Experience of preparing and authoring module 3 CTD, e.g. for IND/IMPD and NDA/MAA/BLA, Superb organizational skills and attention to detail.

Responsibilities:

  • Prepare and support DMFs and NDA/MAA/BLA for customers (for small molecules, ADCs and/or microbial biotech products).
  • Support site specific regulatory documents.
  • Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions.
  • Maintain documented regulatory project plans in line with best practice recommendations.
  • Update functional leads and maintain transparency of information across regulatory function.

Skills and Competencies:

  • Prepare and support DMFs and product licence applications for customers.
  • Provide strategic and operational regulatory direction for projects under responsibility.
  • Lead and implement all submission activities (planning, review, coordination, submission) for new document creation and document updates.
  • Support country-specific regulatory documents.
  • Support assessment of change requests.
  • Oversee preparation of answers to Health Authority Questions or customer requests on regulatory documents.
  • Establish and maintain sound working relationships with internal and external customers.
  • Definition of the necessary source documents together with the project team.
  • Participation in project team meetings.
  • Maintenance and administrative update of company’s own regulatory documents (such as DMF, SMF).
  • Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the LCM-C RA team.
  • Support the implementation of change control activities within the Global Regulatory LCM-C team, as appropriate.
  • Projects under responsibility include development and marketed drug substances (synthetic or semi-synthetic small molecules, biologics or antibody-drug conjugates) for human or veterinary use.

Education:

  • Masters: Biochemistry, Masters: Biology, Masters: Chemistry

Language(s): 

  •  English, French, German

If that interest you then we are looking forward to receiving your application with the following:

  • your CV in English/German
  • latest Work Certificates
  • your Motivation Letter
  • the date of your availability

Apply now to be considered – Good to know you!

For more information and your application, please contact:

Mayank Chaubey, PhD

Consultant Professionals Life Sciences Randstad (Suisse) SA

T +41 58 201 55 62; M +41 79 513 24 83

mayank.chaubey@ch.randstad.com

 

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