Regulatory Affairs - Senior Executive / Executives /Office

Responsibilities of a Regulatory Affairs - Senior Executive / Executives /Office

• Preparation of applications to regulatory bodies for all necessary approvals. FDA, CDSCO, international regulatory bodies.
• To collect and verify all technical documents and information from various departments at the manufacturing site.
• Prepare and review dossiers and submission of dossiers.
• Review of dossiers and compile re-registration documents.
• To reply any queries raised by respective regulatory authority, in timely manner.
• Overseeing of the regulatory process filing necessary applications and handling all government interactions.
• Provide Regulatory support to various departments
• Accompanying development projects and revising already existing technical documentations.
• Liaisoning with responsible regulatory authorities (national/international) as well as with notified bodies.

Skills needed

• Indian FDA guidelines knowledge
• Understanding & knowledge of standards of various international regulatory bodies /ROWBONA/EU
• Organizational Skills- Work assignment, time management, working within strict time frames.
• Ability to solve regulatory queries & compliance matters.
• Knowledge of dossier types and filing requirements,----- CTD/ACTD/E-CTD..

Requirement :

1) Prefer professionals with experience in Document (Process, Analytical) review, Dossier preparation and Submission- for ROW, EU and Other country.

2) Regulatory Affairs Senior Executive / Officers - more than One year experience in Pharma Regulatory Affairs will be preferred

Required Candidate profile

• Effective oral and written communication skills in English Language
• Must have a systematic approach to solving problems.
• Must be able to keep calm and make quick, clear decisions while coping with pressure.
• Excellent PC skills , should be proficient with the usage of the internet as a tool to find necessary & useful information.

Perks and Benefits :

Salary not a constraint for the right candidate based on potential and experience.

Requirement:
Be willing for immediate appointment, if selected