Job Description
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Job Title:  Deputy Manager-Regulatory Affairs
Req ID:  1998
Posting Start Date:  03/11/2026
Job Description: 

Jubilant Bhartia Group

Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S Bhartia and Mr. Hari S Bhartia with strong presence in diverse sectors like Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, Life Science Ingredients, Agri Products, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Jubilant Bhartia Group has four flagships Companies- Jubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited and Jubilant Industries Limited. Currently the group has a global workforce of around 56,000 employees.

Jubilant Pharmova Limited

Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organization (CRDMO), Generics and Proprietary Novel Drugs businesses.

In the Radiopharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Company’s Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectables business offers manufacturing services including sterile fill and finish injectables (both liquid and lyophilization), full-service ophthalmic offer (liquids, ointments & creams) and ampoules.

The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies.

Position Details:

  • Organization: Jubilant Generics Limited
  • Designation: Deputy Manager - Regulatory Affairs
  • Location: Corporate - Greater Noida
  • Job Summary: Lead and manage US Regulatory Affairs activities for assigned product portfolios, ensuring timely preparation, review, submission, and approval of regulatory applications and lifecycle management activities. The role will be responsible for supervising a team of regulatory professionals, allocating work, reviewing deliverables, providing technical guidance and ensuring compliance with FDA regulations and company objectives.

     

Long Description

 

                            Accountabilities                                                       Scope  of work

  • US Regulatory Strategy & Dossier Management
  • Lead preparation, review & submission of regulatory applications for US market, including ANDAs, supplements, amendments, annual reports & correspondence.
  • Review & approve regulatory dossiers to ensure compliance with FDA requirements & company standards.
  • Develop & implement regulatory strategies for new product submissions & post-approval changes.
  • Provide regulatory assessment & classification of mfg, formulation, labeling & packaging changes.
  • Ensure timely response preparation & submission for FDA deficiency letters & regulatory queries.
  • Maintain comprehensive knowledge of FDA regulations, guidance documents, Orange Book requirements & industry trends.
  • Preparation, Review & Submission
  • Review & approve Module 1 & CMC documentation for US submissions.
  • Ensure completeness & quality of submission packages before dispatch.
  • Oversee preparation & review of ANDA submissions, CBE-30 supplements, PAS, Annual Reports, Post-Approval LC Submissions.
  • Ensure timely submission of regulatory filings in accordance with project timelines.
  • Review & approve labeling, artwork, package inserts & prescribing information for regulatory compliance.
  • Support eCTD publishing activities & final submission readiness checks.
  • Coordination

 

 

 

 

 
  • Collaborate with R&D, ADL, QA, Mfg, SCM, PV & Business to support regulatory submissions.
  • Provide regulatory guidance during product development & commercialization activities.
  • Coordinate with API manufacturers & external partners to resolve regulatory & technical issues.
  • Support site transfer projects, alternate source qualifications & TT initiatives.
  • Review technical documents.
  • Technical & Leadership Competencies

 
  • Strong knowledge of USFDA regulations & guidance documents.
  • Hands-on experience with ANDA filing & post-approval changes.
  • Expertise in CMC documentation review.
  • eCTD publishing knowledge.
  • Regulatory strategy development.
  • Labeling & artwork review.
  • Reporting & Maintenance
  • Maintain regulatory files/database/Trackers

 

Person Profile:

  • Qualification: M. Pharma or B. Pharma / PGDRA
  • Experience: 8-10 Years
  • Desired function skills: 
  • Submission planning & project management.
  • Team management and mentoring.
  • Work planning and prioritization.
  • Stakeholder management.
  • Decision making and problem solving.
  • Effective communication and collaboration.
  • Quality and compliance mindset.
  • Desired behavioral skills: 
  • Commitment & ownership
  • Ability to work with Agency time lines
  • Good communication skills

Skills
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