Job title: Associate Manager – CMC Regulatory Writing
Company: Elanco
Job description: Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below. Position Description: This position supports global registration of new an
Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below. Position Description: This position supports global registration of new and existing Animal Health Products by coordinating, preparing and/or delivering registration documentation, data, samples, and reference standards to the global affiliates and agencies. This is done in a timely fashion to support meeting critical registration timelines and is carried out in compliance with Elanco and Global Regulatory standards and guidelines. Functions, Duties, Tasks: Key Responsibilities include, but are not limited to: Coordinate affiliate requested product samples and reference standards for registration purposes Understand analytical test methods and product specifications, calculate needed amounts and identify and order appropriate chemical substances Effectively liaise between Supply Chain, Quality and regulatory affiliates to coordinate complex samples requests meet specified timelines Proactively track and forecast samples needs Work with approved vendors and Elanco Procurement in adherence with Procurement standards to initiate PO’s and process invoices required to route assigned regulatory document work Support affiliates globally by reviewing, coordinating, and/or fulfilling requests for regulatory documents Initiate requests for government issued documents and prepare internally generated administrative documents Route regulatory documents for signatures and legalization Print, scan and ship documents to government agencies and global affiliates Negotiate with affiliates and government agencies around document types and document availability Manage the Elanco LOA/POA template library Support the relationship with Corteva, including collation of information for quarterly updates to Corteva and handling requests to Corteva for utilization of their API with new indications or in new geographies Participate in special projects which support increased efficiency and/or process improvement Other responsibilities, as assigned, to support overall Regulatory objectives and goals Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies. Key Attributes: Excellent organizational, project management, and time management skills Attention to detail Open, clear, and timely communication Strong inter-personal skills and ability to work effectively with cross-functional teams Understanding of the customer needs in order to drive effective solutions. Demonstrated ability to negotiate solutions to complex technical challenges Ability to work in a virtual setting across different cultures and time zones Minimum Qualification (education, experience and/or training, required certifications): Bachelor’s Degree, preferably in a health-related or scientific field or a minimum of 3 years work experience in the pharmaceutical industry, drug development, or in regulatory affairs Advanced Chemical education/knowledge Additional Preferences: Prior Regulatory Affairs experience Multi-lingual Other Information: Domestic and International travel may be required (less than 5% of time). Fluent English is required Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Expected salary:
Location: Bangalore, Karnataka
Job date: Thu, 13 Jan 2022 23:10:22 GMT
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