The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
A Biotechnology Company is seeking a Automation Engineer in Morris Plains, NJ or Remote.
• Responsible for project management, organizing submission documents, preparing and submitting regulatory documents which require interaction with departments outside of Regulatory Affairs CMC for investigational and commercial biologics and small molecule products, in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Examples include original INDs, NDAs, BLAs, amendments, supplements, annual reports and license renewals.
• Perform assessment of CMC changes, identifying global regulatory requirements, and evaluating supporting documentation to assess acceptability and identify potential risks.
• Interact with ex-US affiliates for managing information requests for clinical filings and interact as the CMC regulatory liaison for outside partnerships
• The candidate will be responsible for regulatory operational activities including organizing, tracking, and sending submissions for publishing for the US and other International Markets.
• Compiles documentation for regulatory submission packages including license renewals, updates, and market registration for review and submission to regulatory agencies.
• Provides input to senior Regulatory Affairs CMC professionals in the preparation of country specific labeling and for ensuring product packaging and associated information is updated and maintained in accordance with the product license as applicable.
• Maintains knowledge of regulatory requirements and communicates changes in regulatory information to line manager and regulatory project teams in a timely manner.
Skills & Requirements
• Requires a Bachelor’s degree (scientific filed preferred) and 5+ years of relevant experience in Biologics with Regulatory Affairs CMC experience.
• Experience with IND and BLA submissions.
• Excellent organizational and project management skills; ability to work on a number of projects with tight timelines is required.
• Excellent verbal and written communication skills and interpersonal skills are expected.
• Must be knowledgeable of regulatory requirements, including ICH requirements and US regional requirements
Scientific background is a plus.
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.
Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.
• Life Insurance ($20,000 benefit)
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Hays is an Equal Opportunity Employer including disability/veteran.
In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.
Drug testing may be required; please contact a recruiter for more information. #1140643