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Regulatory CMC Facilitator

Novartis Pharmaceuticals Corporation

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Location: San Carlos, CA Posted Date: 4/12/2013 Position Type: Full time Job Code: 117144BR Required Education: Bachelors Degree

Description

Manage and facilitate all on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements.


1.     Act as single point of contact and advisor for world wide regulatory intelligence information on the site. Maintain a close collaboration with Global Reg CMC in order to keep track with new regulatory requirements, Global Reg CMC strategies and the knowledge of the global product dossiers (CTD module 3).
2.     Support sites in setting standards for regulatory relevant information included in CMC modules (e.g. specifications for raw materials).
3.     Act as member of the local change control review board and advise all contributors (e.g. the Process Units (PU’s) and QA/QC) including the site change coordinator on the regulatory relevance of change requests, provide general strategic regulatory support.
4.     Perform the product independent pre-evaluation of new change requests to assign/confirm category I or category II classification. Consider current regulatory requirements and trends in order to ensure accuracy and completeness of regulatory relevant information in the change requests while including potential regulatory hurdles. Follow up with Reg CMC for product specific regulatory issues after having consolidated all information available at the site.
5.     Support the site in generation of effective change control strategies particularly when changes affect a wide range of products or other sites/divisions.
6.     Support the variation documentation preparation by facilitating timely provision of good quality source documentation and accurate comments from technical experts to Global Reg CMC while ensuring regulatory compliance
7.     Facilitate the timely writing of high quality CMC modules on site in line with agreed CMC regulatory strategies, assuring technical congruency, regulatory compliance and adherence to best practices (e.g. LEAN).
8.     Support the preparation of CMC responses to health authority questions for site specific products.
9.     Support site specific compliance activities; e.g. participate in the remediation work stream. If requested provide regulatory status and relevant registration documentation for the compliance check.
10.   Support preparation of regulatory commitments and declarations. Maintain overview on commitments impacting the site. Train and develop the site’s personnel on regulatory specific aspects of change management by sharing lessons learned and regulatory intelligence information with the goal of improving their skills and capabilities for handling change requests and keeping the highest level of compliance.
11.   Provide regulatory support during local HA inspections.
12.   Participate in the CMC facilitator network sharing lessons learned and providing expertise to facilitators from other sites.

In addition for local products and products produced for other divisions:

13.   Maintain close contact with local DRA for all activities related to local products and in order to follow regional regulatory trends and requirements
14.    Cooperate with the CMC manager of local DRA in formulating the regulatory strategy for the change of the local products based on information at the site. Ensure accuracy and completeness of regulatory evaluation in the change request.
15.   Review the modules written for local products for content, format, completeness, consistency and adherence to best practice.
16.   Maintain archive of currently filed dossiers for local products.
17.   Support processing of changes related to supply to other divisions/external partners.
18.   Support the preparation of CMC responses to health authority questions for local products.

Requirements

Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.

Desirable: Advanced degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. Fluent English (oral & written). Good skills in site (local) language (oral & written).

Other requirements: A minimum of 8 years pharmaceutical or other related industry is required with a minimum of 2 years’ experience working on a manufacturing site (e.g. QA, QC or production) and 2 or more years’ experience in Regulatory CMC.

Working Knowledge of local and global regulations and submission and approval processes for New Chemical Entities (NCE) and product life cycle management.
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