Growing Pharmaceutical, Biotechnology and Medical Device companies always need TOP Talent. Since 1996, MakroScientific’s proven staffing solutions have helped many Life Sciences companies succeed and visualize their goals by increasing innovation and decreasing costs while maintaining the complex service level expectations.
Our global presence with offices in USA (NJ, PA, IL, CA) and offices in UK, Europe and Asia enables us to be a powerful contributor and connector of right Talent.
Job Description 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.
Responsibilities
Compile and complete annual reports with high quality, following regulatory guidelines and internal processes within time lines.
Coordinate with all supporting departments for obtaining documents for annual report submissions.
Archive and maintain all post approval submissions in a systematic way in RA library.
Assists in projects assigned for Post-Approval team (PAS, CBE-30, CBE0).
Assist 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, including scanning, converting to pdf, bookmarking, hyperlinking, electronic processing and uploading in e‑CTD Xpress etc. under superior guidance.
Gain more knowledge in the use of e‑CTD structures for submissions.
Work with colleagues in resolving regulatory issues and/or problems.
Archive and maintain all submissions in a systematic way.
Perform 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.
Requirements
Master Degree is Science or Technical.
Years of experience in Pharmaceutical Industry: 3 years or more.
Type of work: Regulatory Affairs or related coursework.
Proofreading abilities.
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 interface with professionals domestically and abroad.
Ability to work independently, self-starter.
Good problem solving skills and analytical ability.
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.
Qualifications
Master Degree is Science or Technical.
Experience in Pharmaceutical Industry: 3 years or more.
Type of work: Regulatory Affairs or related coursework.
Additional Information All your information will be kept confidential according to EEO guidelines.
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Our global presence with offices in USA (NJ, PA, IL, CA) and offices in UK, Europe and Asia enables us to be a powerful contributor and connector of right Talent.
Job Description 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.
Responsibilities
Compile and complete annual reports with high quality, following regulatory guidelines and internal processes within time lines.
Coordinate with all supporting departments for obtaining documents for annual report submissions.
Archive and maintain all post approval submissions in a systematic way in RA library.
Assists in projects assigned for Post-Approval team (PAS, CBE-30, CBE0).
Assist 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, including scanning, converting to pdf, bookmarking, hyperlinking, electronic processing and uploading in e‑CTD Xpress etc. under superior guidance.
Gain more knowledge in the use of e‑CTD structures for submissions.
Work with colleagues in resolving regulatory issues and/or problems.
Archive and maintain all submissions in a systematic way.
Perform 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.
Requirements
Master Degree is Science or Technical.
Years of experience in Pharmaceutical Industry: 3 years or more.
Type of work: Regulatory Affairs or related coursework.
Proofreading abilities.
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 interface with professionals domestically and abroad.
Ability to work independently, self-starter.
Good problem solving skills and analytical ability.
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.
Qualifications
Master Degree is Science or Technical.
Experience in Pharmaceutical Industry: 3 years or more.
Type of work: Regulatory Affairs or related coursework.
Additional Information All your information will be kept confidential according to EEO guidelines.
#J-18808-Ljbffr