Achieva Group Ltd

Regulatory Affairs CMC Manager

1 day left

CHF68 - CHF77 per hour
02 Feb 2021
04 Mar 2021
Sophie Fosh
Full Time
Contract Type
Experience Level
Senior Management
Job title: Regulatory Affairs CMC Manager

Job Purpose:
Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.

Our large global pharmaceutical client has a new vacancy for a Senior Global Regulatory Manager.
The Senior Global Program Regulatory Manager works independently under limited supervision to provide strategic and operational regulatory direction and may support the global program team representative for programs through development, registration and approval/post approval.
 The Senior Global Program Regulatory Manager ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team representative.

Responsibilities include:
  • Responsible for implementing regulatory strategy and managing operational activities for assigned regions.
  • Determines requirements and sets objectives for Health Authority (HA) interactions
  • Implements strategy across regions in line with global strategy.
  • Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval.
  • Proposes options to minimise risk.
  • Responsible for finalisation and on time submission of annual reports and renewals across assigned regions.

Ideal Background:
  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
  • Life Science BSc minimum
  • Global/ International Clinical Trial Application
  • Experience working with CMC

- Languages: Fluent English required (oral and written).
Good skills in site (local) language desired (oral)

- Experience/Professional requirement:
1.Regulatory experience preferred, and/or experience in drug/bio pharmaceuticals
2.Working knowledge of chemistry/biotechnology, analytic or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
3.Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
4.Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
5.Effective planning, organisational and interpersonal skills.
6.Reasonable approach to risk assessment.
7.Excellent written/spoken communication and negotiation skills.
8.Computer literacy.

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