Regulatory CMC Senior Manager - Switzerland

1 day left

Location
Switzerland
Salary
Competitive
Posted
19 Jul 2019
Closes
18 Aug 2019
Ref
RACMC - CRBG
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Scope of Responsibilities:
This person will work with the Director, Regulatory Affairs very closely and be a member of
multifunctional teams (company internal team members and third party CMO’s). They will provide
support for the needs of the Company from a regulatory point of view to ensure successful applications
with health agencies in the most efficient way. The individual may execute tasks like editing Module 3
sections and play a consultative role when choosing third parties by partnering across business
functions.

Specific responsibilities:
• Responsible for the timely completion of well organized, scientifically sound regulatory CMC
submissions, to include agency meeting packages, DMFs, INDs, CTXs, NDAs and MAAs,
amendments and supplements, responses to requests for information, etc. Writing of
Module 3 sections/participation in submission preparation is expected.
• Maintains an in depth level of understanding of the assigned compounds, their
characteristics, manufacturing aspects and specifications/analytical methods
• Reviews technical reports and summary documents (chemistry, manufacturing and quality)
for adherence to regulatory guidelines, strategies, and commitments.
• Contributes to writing expert summaries of CMC submissions
• Leads third party CMC teams on task forces as needed
• Leads RA review of Change Controls and co-ordinates with QA to ensure successful
implementation
• Leads preparation for CMC meetings with Health Authorities
• Maintains an understanding and awareness of existing and forthcoming legislation and
guidelines related to CMC.
• Provides regulatory expertise and policy support for GMP and represents the RA team as
CMC expertise on project teams

Work Experience/Education:
• Minimum of 5 years pharmaceutical/biotech industry experience in CMC Regulatory Affairs with
at least 10 years in the pharmaceutical industry in a technical compliance role of which 5 years
working with FDA/EMA related projects.
• Bachelor’s degree in scientific discipline preferred, or comparable experience.

Functional/Technical Knowledge & Skills:
• Strategic thinker, planner, and implementer. Excellent organizational skills.
• Excellent communication skills, knows how to present data/issues both to a technical and nontechnical audience
• Able to plan and execute regulatory projects, and proven record of delivering results within
business-defined timeframes.
• Sound knowledge of FDA/ EMA regulations and guidelines in the CMC arena, including GMP.
Knowledge of requirements in other regions is of advantage.
• Ability to write and edit technical documents
• Proven ability to work on complex problems where analysis of the situation or data requires an
evaluation of intangible variables.
• Demonstrates potential for a high level of collaboration with others and independent thought.
• Candidate must be fluent in English (verbal and written)
• Proficient in Microsoft Outlook, Word & Excel

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