Reg Affairs - CMC - Basel
On behalf of one of the top 3 Pharma companies who are looking for a Regulatory Affairs, Associate Manager, on a contract basis for at least 12 months to be based in Basel, this is a contingent worker role, where extensions are expected, giving you longevity in the role. It also is a chance to be a part of one of the largest pharmaceutical companies in the world, where extensions are expected allowing you to gain exposure with a reputable name and ultimately build further value for your profile. This is a contract with guaranteed working hours of 40 hours per week, paying 55CHF an hour.
1.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.
2.Prepare CMC responses to health authority questions during development, registration and product lifecycle.
3.Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
4.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.
5.Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
6.Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
7.Establish and maintain sound working relationships with partners and customers.
8.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).
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
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)
- Experience/Professional requirement:
1.Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
2.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.
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, organizational and interpersonal skills.
6.Reasonable approach to risk assessment.
7.Excellent written/spoken communication and negotiation skills.
Call me Daniel Watson at NonStop Recruitment now for a confidential conversation. Contact me on D.Watson@nonstop-recruitment.com or +41 435 080 817, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a clinical research professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
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