Full Time
Gurgaon, Mumbai
Posted 3 days ago

JOB DESCRIPTION

Job Title: Regulatory Affairs Sr. Associate (API)

Job purpose:

To ensure that the below-listed tasks should be done carefully for a successful submission, and approval of the assigned products.

Education & Experience:

  • MSc. Biotechnology
  • 3+ years of experience in handling Regulatory Affairs function.

Roles & Responsibilities:

  • Reviewing of the DS part of the dossier for the US, EU, and ROW.
  • Reviewing of SFDA templates and compiled a dossier of Drug Substances.
  • Reviewing of e-Functionalities and eCTD published dossiers.
  • Level-1 review of Analytical method validations.
  • DMF review and gap sheet release for US, EU, and ROW.
  • Preparation of Query responses and client responses.
  • Archival of master data and emails received from respective clients.
  • Review of Product History Sheet & management of the data in the server of the respective projects.
  • Updated guidelines review.
  • Self-training and improvement.

Knowledge, Skills and Abilities:

  • Excellent technical data interpretation skills.
  • Strong project management skills.
  • Excellent interpersonal skills including problem solving.
  • Strong negotiation skills.
  • Excellent oral and written communication skills with strong presentation skills.
  • Significant knowledge of global, regional, national and other document development guidelines.
  • In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
  • Great judgment and decision-making skills.
  • Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
  • Ability and desire to work in a team-oriented environment.
  • Excellent written and verbal communication skills.
  • Highly proficient with Microsoft Word, PowerPoint and Excel.
  • Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner.
  • Possesses a collaborative, results-driven style.
  • Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines.

Location: Gurgaon /Mumbai

No. of Openings: 3 positions

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