Regulatory Affairs CMC Associate Manager (m/f/o)

Peppercorn - talent acquisition. For more than 30 years, we support our clients in the personnel recruitment for fixed and temporary placements. We are a financially independent company within the FAVORIS group.

For an international pharmaceutical company located in Basel we are looking for a:

Regulatory Affairs CMC Associate Manager (m/f/o)

Purpose:


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



Tasks & Responsibilities:
 

• 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).

Requirements:
 

• Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
• Fluent English required (oral and written)
• Good German skills desired (oral)
• 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

Start date: 01.03.2021
End date:  17.12.2021, extention possible
Work location: Basel
Workload: 100%