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Senior Associate-R&D

Senior Associate-R&D

Elanco

5 - 10 years

7 - 10 Lacs

bengaluru

Posted:13 hours ago| Platform:

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Skills Required

training pharma focus global strategy regulatory compliance management regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

The purpose of Associate Manager/Manager/Senior Manager - Regulatory, is to work cross functionally with Elanco R&D groups, Manufacturing and Quality to develop global regulatory strategy, oversee submission preparation and meet the reporting requirements for the Authorization and Maintenance of registrations of new animal drugs with global regulatory agencies

Demonstrated knowledge of the drug development process and regulatory submissions with expertise in end-to-end life cycle management (LCM) of a multitude of complex pharmaceutical dosage forms

Design/develop regulatory strategy for geo-expansion of marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance

Maintain a positive collaboration and partnership with internal groups in R&D, Quality, Manufacturing and with global regulatory business partners of Elanco

Contribute to pre-submission preparation and proactively communicate regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams, while applying the global strategy into submissions

Ensure the required documentation and any content, quality and/or timelines for global submissions are communicated to the appropriate teams and tracked according to the functional procedures

Keep knowledge up to regarding regulatory guidelines and requirements in all global regions as well as for new technical trends

Minimum Qualification (education, experience and/or training, required certifications):

Degree in Science (BSc; MSc, B
Pharm/M Pharm, Postgraduate in Vet Sciences etc , )

Minimum Experience:

5+ years in Global Regulatory Affairs

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

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Elanco

Pharmaceutical Manufacturing

Greenfield IN

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Senior Associate-R&D