Junior Regulatory Affairs CMC Manager in Biologics
Posted on Jan 9, 2021 by Stamford Consultants AG
Under supervision, provide timely preparation of high-quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.
The following tasks are to be performed as assigned:
1. Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruence and regulatory compliance, meeting agreed-upon timelines and e-publishing requirements throughout the project life cycle.
2. Prepare CMC responses to health authority questions during development, registration, and product life cycle.
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 strat-egy, 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 depart-ment functions).
Degree in Science (eg 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) (German)
1. Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
2. Working knowledge of chemistry/biotechnology, analytics, or pharmaceutical technology. Knowledge is 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.
8. Computer literacy.
Aerotek, an Allegis Group company. Allegis Group AG, Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek is a company within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on the website.
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