Senior Specialist- Regulatory Affairs

Job Summary:

Regulatory Affairs Specialist

Key Responsibilities:

1. Regulatory Submissions & Product Maintenance

• Prepare, compile, and support regulatory submissions (renewals, site registrations, and minor variations) for India and APAC countries.
• Assist in maintenance of registrations and product licenses in regulatory systems (e.g.,

  Veeva Vault

  ,

  SharePoint

  , internal databases).
• Support

  labeling review

  and

  project creation

  in the

  Artwork Management System

  (WebCenter).
• Ensure timely dispatch and tracking of dossiers for regulatory applications.

2. Regulatory Systems & Documentation

• Maintain up-to-date records of submissions and approvals in regulatory systems.
• Perform regular updates in

  Veeva Vault

  related to life cycle management (LCM) activities.
• Assist with generation of regional and local regulatory reports.

3. Cross-functional & Operational Support

• Coordinate

  sample requests

  through internal platforms (e.g.,

  K2 system

  ).
• Support

  vendor payments

  and country-specific administrative tasks.
• Facilitate communication within the RA team (top-down and bottom-up) and with other internal functions.

4. Regulatory Intelligence & Process Improvement

• Conduct

  regulatory intelligence

  searches and maintain country-specific updates in the

  Country Regulatory Tool system

  .
• Participate in regional/global/local

  process improvement initiatives

  and support harmonization of hub procedures.
• Assist in the review and refinement of internal RA processes to improve efficiency.

5. Stakeholder Engagement & Strategic Alignment

• Align with internal stakeholders and country RA teams on submission strategies for India and APAC.
• Collaborate with global RA counterparts to ensure alignment with corporate policies and timelines.

6. Additional Responsibilities

• Provide support for

  CDSCO, Import Licensing, and State FDA

  requirements.
• Represent Regulatory Affairs in cross-functional meetings when required.
• Travel as needed to support business requirements.

Qualifications & Requirements:

• Educational Background:

• Bachelor's or Master's degree in

  Pharmacy

  , or

  PhD

  in a related field.

• Experience:

• Minimum

  510 years of experience

  in

  Indian Regulatory Affairs

  .
• Strong working knowledge of

  CDSCO

  ,

  Import Registration

  , and

  State FDA

  regulations.
• Experience working with APAC regulatory submissions is a plus.

• Technical Skills:

• Proficient in

  Veeva Vault

  ,

  SharePoint

  ,

  Artwork Management Systems

  , and

  regulatory documentation platforms

  .
• Familiarity with tools like

  K2

  , vendor payment systems, and document tracking tools.

• Soft Skills:

• Excellent

  verbal and written communication

  in English.
• Strong

  organizational, analytical

  , and

  problem-solving

  skills.
• Ability to manage multiple tasks simultaneously and work independently.
• A collaborative team player with a proactive mindset.