Job Description

• The Regulatory Affairs Associate, with minimal guidance prepares, reviews and submits high quality annual reports with FDA within Annual report timelines and in accordance with regulatory guidelines and applicable federal laws.
• With minimal guidance, ensure to compile and complete the Annual reports of high-quality, following the regulatory guidelines and internal processes within time lines.
• Coordinate with all supporting departments for obtaining documents for annual report submissions.
• Should archive and maintain all post approval submissions in a systematic way in RA library.
• Assists in Projects Assigned for Post-Approval team (Client, CBE-30, CBE0).
• Assists technical services team by providing required information from the submissions as and when required.
• Organize and maintain submission components associated with a regulatory submission electronically.
• This may include scanning, converting to pdf, bookmarking, hyper linking, electronic processing and uploading in e-CTD Xpress e.t.c. under superior guidance.
• Gain more knowledge in the use of e-CTD structures for submissions.
• Works with colleagues in resolving regulatory issues and/or problems.
• Should archive and maintain all submissions in a systematic way.
• Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department.
• Maintain current knowledge of regulations and other issues that affect products and industry.
• Maintain the regulatory databases up to date and as per the set criteria's.

Requirements:

• Master's degree is Science or Technical, at least 3 Years of experience in Pharmaceutical Industry.
• Regulatory Affairs or related coursework.
• Working knowledge and experience with 21 CFR, US FDA guidance, ICH guidelines.
• Strong computer skills in order to learn new programs as quickly as possible.
• Experience in MS Word, Excel, Outlook and Adobe Acrobat is a must.
• Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required.
• Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects.
• Excellent written and verbal communication skills and interpersonal skills.
• Ability to communicate effectively and collaboratively as part of a team in a respectful manner.
• Ability to work independently, self-starter.
• Good problem-solving skills and analytical ability.
• Strong computer skills to learn new programs as quickly as possible.
• Experience in MS Word, Excel, Outlook, and Adobe Acrobat is a must.

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