Regulatory Compliance Specialist

Hi [[CandidateFirstName]],

I came across your resume. I have a fast moving opportunity with our direct client. Following is the position details. Please let me know if you are available/interested so we can further discuss this position. Also email me your resume and contact number where I can call 

Regulatory Compliance Specialist

Location: Parsippany NJ 

Duration: 6+ months (posibility of extension)

Description 

This position provides regulatory support in regards to several internal and external processes for the regulatory compliance of clinets final products including: ingredient disclosure, Safety Data Sheets, WERCSmart, DOT hazardous materials shipping, US Customs, and the management of DEA controlled substances.

This position reports to the Compliance Manager and will interface on a regular basis with the various internal regulatory staff. Other key stakeholders include Sales, Legal, R&D, Quality, Logistics Centers and Manufacturing sites. 

Key Responsibilities 

• Compliance Activity-Customs & Border, Controlled Substances 

o Support activity surrounding Import compliance for US Customs & Border, Health Canada, Transport Canada

o Support activity surrounding US DOT Hazardous Materials Shipping

o Support activity surrounding to DEA Licensing for logistics centers and Year End Diversion tabulation

o Support activity for FDA- ACE submissions

• Database Management 

o Support maintenance of various databases including: clients internal ingredient disclosure database, clients website, TDS, Customs, and the external WERCS portal for product registration

o Provide reliable interpretations of regulations and guidance documents

o Assists in the tracking, archival and retrieval of regulatory information for website submissions/licensing following instructions from supervisor 

Qualifications 

• BA/BS degree required in the natural or Life Sciences.

• 1-2 years in the area related to Regulatory Affairs/Regulatory Operations

• Experience in consumer products industry and DEA regulated products is highly preferred

• Able to read, understand, and apply regulations to company's activities

• Demonstrate a basic understanding of the rules governing development and approval of SDS, formulation, and Pharmaceuticals/Medical Devices

• Familiarity with the structure of a regulatory submissions via web portal and/or dossier

• High attention to detail

• Excellent database programming, word processing and computer skills

• Must be team oriented and be able to work well with others 

• Exhibit some independent problem solving skills on routine problems

• Able to work independently and as part of a team within deadlines as imposed by internal guidelines

• Ability to provide metrics/progress reports on project milestones

Feel free to forward the job to your friends or colleagues who might be available or interested for this position!!

Thanks & Regards,

Seema Chawhan

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I

DIRECT # - 732 – 318 -6506 | (W) # 732-549-2030 – Ext – 324 | (F) 732-549-5549

Email id – seema @irionline.com| www.irionline.com 

LinkedIn: https://in.linkedin.com/in/seemachawhan

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