Specialist - IM&S
Novartis
Hyderabad, AP India
2d ago

Your responsibilities :

Your responsibilities include, but are not limited to :

1. Support regulatory teams during the submission process in all administrative and technical steps according to global procedures

2. Prepare and dispatch / submit documentation packages for predefined submission types and region(s) in compliance with Health Authority requirements

3. Ensure eCTD lifecycle maintenance according to ICH and regional specifications

4. Ensure timely update of submission data in the regulatory information management data-bases and verify that the data is kept compliant

5. Be involved in the timely and efficient processing of regulatory, submission-relevant docu-ments like M1, eApplication Form, COPPs, GMP Certificates

6. Maintain communication network with regulatory functions like RCCs, MRCc and country organizations and non-regulatory stakeholders according to guidance documents

7. Ensure escalation procedures are followed in case of issues and delays

8. Might be involved in document preparation activities like scanning, bookmarking, linking and other activities to ensue document submission readiness

9. Might be involved in document bulk upload activities

Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic.

1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking : how can we continue to pioneer access in an ever-

more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Join us, and help reimagine access to medicine.

Minimum requirements

What you’ll bring to the role :

1. Masters Degree in Science or Pharmacy with Minimum 2 years to 5 years of relevant experience in Regulatory submission publishing.

2. Ability to plan and priorities workload

3. Ability to work in a matrix environment

4. Ability to build effective relationships across teams

5. Active command in English with excellent written and spoken communication skills

6. Good knowledge of Regulatory tools.

7. Creative thinking and effective interdisciplinary collaboration with other functions.

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