Regulatory CMC Associate Manager

Harvey Nash is looking for a Regulatory CMC Associate Manager for a 10 month project in Switzerland.

The role is for a candidate to provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.

You are responsible for

. Authoring 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 life cycle
. Preparing CMC responses to health authority questions during development, reg-istration and product life cycle
. Identifying the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
. Identifying 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
. Keeping knowledge up to date with regard to regulatory guidelines and require-ments in all global regions as well as for new technical trends
. Actively participating as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned
. Establishing and maintaining sound working relationships with partners and customers
. Assuming activities in support of the general department such as annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions)

Minimum:

Degree in Science (eg 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)

Requirements:

. 0-4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
. Working knowledge of chemistry/biotechnology, analytics or phar-maceutical technology. Knowledge of the drug development pro-cess 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

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.