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Novartis Hiring For Regulatory Promotional Material Submission Specialist

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B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Hyderabad

1 - 2 Years | Freshers can Apply Too

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Novartis is hiring a Promotion Submission Specialist for its Hyderabad office. The role focuses on preparing and submitting pharmaceutical promotional materials to the US Food and Drug Administration (FDA), including submissions to the Office of Prescription Drug Promotion (OPDP) and the Advertising and Promotional Labeling Branch (APLB).

Candidates with pharmaceutical industry experience, document submission system knowledge, and skills in regulatory documentation can explore this full-time opportunity.

Novartis Recruitment 2026 – Job Details

ParticularsDetails
CompanyNovartis
Job TitlePromotion Submission Specialist
Job LocationHyderabad, Telangana, India
Work ModeHybrid
Office Requirement3 days per week
Job TypeFull-time
Experience1–2 years of pharmaceutical experience preferred
QualificationBachelor’s degree or equivalent education and/or experience preferred
Job Requisition IDREQ-10089387
Application DeadlineOctober 30, 2026

About the Role

The Promotion Submission Specialist prepares electronic submissions of promotional materials for FDA review. The role includes submissions at first use, requests for advisory comments, and pre-submissions of promotional materials for products under accelerated approval.

The specialist also tracks submissions, maintains relevant procedures and SOPs, monitors applicable FDA regulations, and coordinates with regulatory, marketing, publishing, IT, and compliance teams.

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Key Responsibilities

  • Prepare electronic submissions of promotional materials at the time of first use.
  • Prepare submissions for advisory comments and promotional materials for products under accelerated approval.
  • Use electronic promotional material review systems to complete assigned submission tasks.
  • Support the development, implementation, and maintenance of administrative procedures, working practice documents, and SOPs.
  • Stay updated on FDA regulations, guidance, legal requirements, and Novartis document standards.
  • Prioritize and track submissions while managing daily workloads.
  • Coordinate with Regulatory Advertising and Promotion Reviewers, DRA Operations, publishers, IT, CA&PE, Brand Marketing, and Ethics and Compliance teams.
  • Use AI tools to streamline tasks, generate content, and support decision-making.

Eligibility and Qualifications

Candidates should meet the following preferred qualifications and experience requirements:

  • Bachelor’s degree or equivalent education and/or experience.
  • 1–2 years of pharmaceutical industry experience preferred.
  • Working knowledge of desktop computing and Microsoft Office products.
  • Experience with Adobe Acrobat and other operating submission systems.
  • Ability to learn new systems and programs.

Required Skills

Applicants should demonstrate:

  • Electronic document preparation and submission skills.
  • Workload planning and prioritization.
  • Analytical and problem-solving abilities.
  • Effective written and verbal communication.
  • Strong interpersonal and coordination skills.
  • Flexibility and focus on timely, high-quality submissions.
  • Ability to work independently with limited supervision.
  • Practical proficiency in using AI tools, including prompting, interpreting outputs, and refining results.

Work Schedule and Location Requirements

  • Location: Hyderabad NKC office.
  • Work arrangement: Hybrid, with three days per week in the office.
  • US business hours availability: Candidates must be available during 6:00 PM–10:00 PM IST, or the corresponding US business hours of 7:30 AM–11:30 AM EST, as specified in the job description.
  • Additional availability: Advance coordination for US holiday coverage and on-call availability for critical matters, depending on business needs.
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APPLICATION DETAILS

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