Regulatory Associate/Sr Regulatory Associate
Updated: Today
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002287
Description
Regulatory Associate/Sr Regulatory Associate
Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. Our Clinical Development model places the customer and the patient at the center of all we do. We aim to simplify and streamline work processes, making Syneos Health easier to work with and work for.
Why Syneos Health:
Career development, progression, and peer recognition.
Supportive and engaged line management.
Commitment to a Total Self culture where you can authentically be yourself.
Job Responsibilities:
Essential Functions:
For non-complex submissions, independently fulfill the following responsibilities. For complex submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues:
Prepare Module 3 sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations, and other lifecycle maintenance activities in compliance with current regulations.
Prepare and submit full applications or components of IND, marketing, and lifecycle maintenance applications.
Experience with Veeva RIMS, including creation of objectives and submission content plans, is preferred.
Conduct information processing activities with high reliability, ensuring quality and meeting tight timelines.
Undertake project-specific activities with minimal supervision within cost and time estimates.
Maintain records, logs, and update regulatory databases per Syneos Health and/or client requirements.
Conduct Quality Control reviews of documents, ensure review and tracking until final submission.
Attend client meetings and build client relationships to support projects and deliverables.
Review work, track performance and productivity of Regulatory Associates and other Senior Associates, and coordinate with the project manager.
Identify risks to project delivery related to workload and escalate appropriately.
Assist in training and mentoring of team members based on project requirements.
Maintain individual training records and complete all required training.
Qualifications:
What We’re Looking For:
MS/M.Pharm, or equivalent combination of education and experience.
Minimum 6 months of experience for Regulatory Associate and 1.5 years for Sr Regulatory Associate.
Excellent interpersonal and communication skills.
Advanced skills in Microsoft Office Applications.
Hands-on experience with RIM systems such as Veeva RIMS and TrackWise preferred.
Strong analytical skills and attention to detail.
Ability to work independently and follow detailed instructions.
Ability to interact with staff from multiple departments.
Ability to work concurrently on multiple projects.
Fluent in speaking, writing, and reading English.
Get to Know Syneos Health:
Over the past 5 years, we have worked with:
94% of all Novel FDA Approved Drugs.
95% of EMA Authorized Products.
Over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
Additional Information:
Tasks, duties, and responsibilities listed in this job description are not exhaustive. Equivalent experience, skills, and/or education will be considered, and the company retains discretion in defining qualifications. The Company is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations as appropriate.
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Auckland |New Zealand :
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Tallinn |Hà Nội :
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