Job Description

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals\' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco\'s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

Position Title:

Analyst - CMC Regulatory

Supervisor Title:

Group Leader/Team Leader

Job Path/Level:

P1

Position Type:

Full Time

Job Function:

Global Regulatory CM&C

Location:

Bangalore, Karnataka, India

Position Description:

The purpose of Analyst, Global CMC Regulatory, is to work closely with CMC product managers in sourcing of supporting documents, compilation of CMC dossier sections, tracking of project status and other administrative tasks as needed for the maintenance of registrations of established animal drugs with global regulatory agencies.

This role also executes Veeva Vault related tasks such as authoring, review and approval workflows of CMC dossier sections, initiation of change impact assessments and tracking the submission/approval status.

The person must have a good knowledge of ICH/VICH topics, US FDA and EU quality guidelines.

Functions, Duties, Tasks:

• Author high-quality CMC documentation for submission, under the direction of a CMC product manager, assuring regulatory compliance
• Execute administrative tasks within the Regulatory Information Management System as required to support the maintenance of registrations of established animal drugs
• Maintain a positive collaboration and partnership with internal groups in R&D, Quality and manufacturing
• Maintain a positive business collaboration and partnership with global regulatory business partners of Elanco
• Proactively communicates key issues and any other critical topics related to the submission activities in an adequate and timely manner to CMC product managers
• Ensure the required documentation and any content, quality and/or timelines for global submissions are communicated to the CMC product managers and tracked accordingly
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends

Core Competencies:

• Knowledge of FDA and EU guidelines
• Experience with CMC dossier compilation in CTD for multiple dosage forms
• Strong communication skills, both written and oral
• Ability to make decisions when there is no clear right or wrong answer
• Self-starter, takes initiative
• Timeline driven
• Attention to detail
• Quality and customer focused mindset
• Is able to handle multiple tasks while meeting the agreed upon time frame

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

• Master\xe2\x80\x99s Degree in Science (M. Pharm or MS/MSc in Pharmaceutical and Allied Sciences or Postgraduate Degree in Vet Sciences etc.,)

Minimum Experience:

At least 5 years relevant experience in Global Regulatory Affairs

Additional Preferences:

• Experience working with Regulatory Information Management Tools and Systems

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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