Regulatory Affairs CMC Senior Manager / no-603

Location
CH-Basel
Start
01/04/2022
End
31/12/2022
Workload
100 %
All-in / Hour
60chf/h gross
Total Hours
1.568

Deadline:

 

Regulatory Affairs CMC Senior Manager / no-603

Location
CH-Basel
Workload
100 %

Start

01/04/2022

End

31/12/2022

DEADLINE

  • CH-Basel
  • CH-Basel01/04/202231/12/2022100 % 1.56860chf/h gross

For our customer located in Basel/Switzerland we are currently looking for a: Regulatory Affairs CMC Senior Manager (m/f/d)

  • Location: Basel
  • Branch: Pharma
  • Duration: 8 months+

Tasks & Responsibilities

  • Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
  • Prepare CMC responses to health authority questions during development, registration and product lifecycle.
  • Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
  • Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
  • Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
  • Establish and maintain sound working relationships with partners and customers.
  • Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).

Must Haves

  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • Desirable:
    Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
  • Languages: Fluent English required (oral and written).
    Good skills in site (local) language desired (oral)
  • Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
  • Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
  • Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
  • Effective planning, organizational and interpersonal skills.
  • Reasonable approach to risk assessment.
  • Excellent written/spoken communication and negotiation skills.
  • Computer literacy.

Did we catch your interest? 

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Preferred Interview Dates

Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
More optional Information about your way of finding us
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

  • CH-Basel
  • CH-Basel01/04/202231/12/2022100 % 1.56860chf/h gross

For our customer located in Basel/Switzerland we are currently looking for a: Regulatory Affairs CMC Senior Manager (m/f/d)

  • Location: Basel
  • Branch: Pharma
  • Duration: 8 months+

Tasks & Responsibilities

  • Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
  • Prepare CMC responses to health authority questions during development, registration and product lifecycle.
  • Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
  • Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
  • Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
  • Establish and maintain sound working relationships with partners and customers.
  • Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).

Must Haves

  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • Desirable:
    Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
  • Languages: Fluent English required (oral and written).
    Good skills in site (local) language desired (oral)
  • Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
  • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
  • Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
  • Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
  • Effective planning, organizational and interpersonal skills.
  • Reasonable approach to risk assessment.
  • Excellent written/spoken communication and negotiation skills.
  • Computer literacy.

Did we catch your interest? 

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Preferred Interview Dates

Files must be less than 5 MB.
Allowed file types: txt rtf pdf doc docx.
If not - no problem - we'll organize one.
More optional Information about your way of finding us
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.

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