Requirement of Regulatory Affairs - Pharm Chemicals Solution in EMD Millipore, Division of Merck & Co. | US - MA - Billerica
Millipore is a Life Science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. As a strategic partner, we collaborate with customers to confront the world's challenging human health issues. From research through development to production, our scientific expertise and innovative solutions help customers tackle their most complex problems and achieve their goals.
Post: Regulatory Affairs - Pharm Chemicals Solution
• Creating good relations and advocacy of PCS (MM) interests in industry business organizations and with authorities, e.g., RX-360, IPEC, EFCG
• Effective coordination of strategic activities of experts in global regulatory bodies and business associations
• Secure flow of information from/to regulatory bodies and business associations and PCS global organization
• Safeguard PCS BF strategic interests and objectives in arising guidance, standard and regulations
• Actively participates and represents MM in business associations, RX-360, IPEC, EFCG
• Builds and keeps personal relationships to local, national and international authorities
• Coordinates processes with internal functions for the commenting/drafting of guidelines, regulations and standards
• Increases the influence of PCS in important regulatory bodies and business associations, e.g., RX-360, IPEC, EFCG
• Respond to customer regulatory and quality inquiries, need to understand their product portfolio.
• Coordinate the completion of various customer regulatory documents
• Remain current and knowledgeable on regulatory changes and evaluate their effects and impact on business
• Scientific and technical support and satisfy the request of customers about regulatory in collaboration with regulatory service in MDA
• Responsible for all quality complaints for Trackwise workflow and complaints definition
• Follow up of all relevant local regulatory development
• Training of sales and marketing as well as customer on regulatory topics.
• Consults and inform global marketing and sales about new trends and developments
• Coordinates lobbying activities of experts in regulatory bodies and business associations
• Builds processes for the flow of information and regulatory intelligence within the PCS organisation
• Decision on the implementation of regulatory requirements after consultation of Marketing and Product - Management
• Definition of processes to implement upcoming regulatory needs and requirements
• Diploma Chemistry, Pharmacy, Biology or related Health Science
• Knowledge of Chemical, pharmaceutical Regulation in VRC, SFDA.
• Knowledge in Regulatory Affairs, QM, QA, QC and proficient in MS Office software (Word, Excel, Power point).
• Demonstrated good communications & project management skills
Education: Diploma in Chemistry, Pharmacy, Biology
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: DRA
End Date: 26th Nov., 2011
Job ID: 1101993
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