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Regulatory Alliance Manager Vacancy 2021 @ Novartis
Novartis invited candidates with an MSc degree in chemistry for the post of Regulatory Alliance Manager. Pharma job opening 2021. Pharmacy job 2021. Regulatory Alliance Manager job opening 2021. Pharma job opening 2021. Pharmacy job 2021. Check out all the details
Job Id: 319880BR
Job Title: Regulatory Alliance Manager
Minimum requirements
What You’ll bring to the role:
• Higher University education preferably in Chemistry, Pharmacy or other natural sciences
• Min. 3-5 years in regulatory roles of the pharmaceutical industry
• Good communication skills
• Experience in direct customer contact will be preferred
• Knowledge of Regulatory guidelines for the areas mentioned above
• Organizational awareness and experience working cross-functionally and in global teams is a plus
• Ability to work under pressure, demonstrating initiative and flexibility
• High-level understanding of Regulatory quality, standards, and policies.
Your Responsibilities
Your responsibilities include, but not limited to:
• Act as single point of contact for all customer-related regulatory topics. Provide expert guidance in developing regulatory strategies for specific business opportunities. Coordinate regulatory support with Global DRA
• Regularly participate in customer meetings (F2F and conference calls) and lead the discussion on regulatory topics.
• Monitor/understand internal and external business drivers and manage site-/product-related resources (Reg. Affairs, Production, QA) to fulfil requirements from regulatory authorities and customers with API and FDF related inquiries
• Expand and maintain a network of contacts in all relevant production sites and with internal and external technical and regulatory experts, participate and/or organize meetings and conferences to gather relevant information. Represent B2B in the local and global Sandoz regulatory setup
• Act as a service expert in B2B with a detailed technical, quality and regulatory product and process know-how and highly developed communication skills
• Support sales teams to coordinate technical and regulatory customer inquiries (incl. claims, questionnaires, etc.) with internal functions (Reg. Affairs, Production, QA, Product Managers, etc.) to facilitate growing sales with new customer/product combinations. Provide cutting-edge services on technical, quality-related and regulatory services to customers
• Update and maintain product (API) filings with regulatory bodies (FDA, EDQM, etc.); organize and distribute regulatory documents (e.g. CEPs, etc.)
• Secure adherence to quality systems, internal guidelines, customer needs and local market regulations in countries worldwide. Develop a regular training sequence for the CSA and Sales teams to make them more familiar with the product-related TCC service portfolio and the relevant procedures
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