Assistant Manager - Regulatory Affairs (US)

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations.

Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets.

Kindly refer www.jubilantpharmova.com for more information about organization.

JOB RESPONSIBILITIES:

;;;;;;;;;;;;; Accountabilities;;;;;;;;;;;;;;;;;;;;;;;;;;; Scope of work

• US

• Drug Dossier Authoring, Reviewing and Submission of ANDA (US)
• Product life cycle management (LCM) activities
• Assessment of post approval changes
• eCTD publishing
• Thorough knowledge of CMC and Module 1 requirements
• Labelling submission, SPL preparation

• Preparation and Submission

• Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline.
• Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities.
• Artworks (PIL, labels) and labeling files preparation along with SPL preparation.
• Coordinate with cross-functional teams for desired regulatory data and accordingly plan and complete regulatory filing activities
• Review and finalization of artwork/label as per current guideline.
• Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends
• eCTD publishing

• Coordination

• Interface with R and D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner
• Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements
• To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R and D/ADL against DMF/Dossier requirements

• Reporting and Maintenance

• Maintain regulatory files/database