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