Senior Regulatory Affairs CMC Manager

Employer
CTC Resourcing Solutions
Location
Basel, Canton of Basel-Stadt (CH)
Salary
Negotiable
Closing date
18 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
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Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.

We are currently looking for a Senior Regulatory Affairs CMC Manager to be based in Basel for a 12-months contract position.

As a Senior Regulatory Affairs CMC Manager, you will provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.

Main Responsibilities:

  • Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance;
  • Support implementation of all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products;
  • Produce high quality strategic project documentation and presentations (e.g., project plans, strategic documentation, lessons learned);
  • 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).

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required;
  • Bachelor/Advance Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent;
  • 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.

Due to our reputation for excellence and our proactive approach to networking and promoting CTC, we are able to engage the very best talent, and consequently work with the very best employers in the market who are serious about bringing talent to their organisation. If you are looking for a reliable partner with:

  • Established client and candidate network
  • Excellent and detailed knowledge of local requirements
  • Solid reputation
  • Quick and flexible approach to recruitment
  • High quality of service
  • People focused

Depending on your needs and situation, we offer business partnerships with flexible solutions that can be tailored to your specific resourcing needs - all with a collaborative, open, and friendly approach.

We recruit in the following areas:

  • Pharma/Biotech:
    • Clinical Development
    • Pre-Clinical Development
    • Regulatory affairs
    • Pharmacovigilance
    • Sales & Marketing
    • Supply Chain
    • Communications
    • Medical Affairs
    • General Management
  • Medical Devices / MedTech:
    • Engineering & Product Development
    • Quality & Manufacturing
    • Technical Writing
    • Regulatory Affairs
    • Sales & Marketing
Contact Us
  • Münchensteinerstrasse 41
  • Münchensteinerstrasse 41
  • Basel
  • CH
  • +41 61 695 88 66
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