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Regulatory Affairs Associate – II

American Cybersystems, Inc. (ACS Group) california Full-Time
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My name is Rohit  I’m a Recruiter with ACS Group, a leading information technology services and workforce solutions company, and I’m contacting you about an opportunity with one of our clients. ACS works closely with Fortune 1000 firms throughout the US and provides top talent for various staffing needs across industries.

 

Please review the Job Description provided below and if interested, please call me at 770-255-7921 OR reply to this email

 

Kindly send your current and updated CV in MS Word Format for evaluation, scrutiny, assessment and possible consideration

Below are the Details of Opportunity

 

Requisition Title:    Regulatory Affairs Associate – II

Location: Foster City, CA

Duration :6+ months

Responsibilities:

Responsible for preparing regulatory submissions which require some interactions with other members in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.

Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity.

Responsible for development and acquisition of required regulatory skills and knowledge, with manager support.

May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.

Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department

Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs.

Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.

Seeks assistance from appropriate internal and external resources.

Knowledge and Skills

Strong organizational and attention to detail, along with the ability to work on a number of projects with tight timelines.

Strong verbal and written communication skills and interpersonal skills.

Must have a reasonable understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.

Proficiency in Microsoft Word and Excel.

Experience with Microsoft Power Point, Project and Visio a plus.

Act as a resource on limited topics within the department.

Work is performed under the general supervision of more senior Regulatory Affairs professionals and is reviewed for soundness of judgment and overall adequacy.

Education and Experience

4+ years of relevant training or industry experience with BS/BA.

3+ years relevant training or industry experience with advanced degree.

Degree in a scientific field is preferred.

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ACS Group is a premier provider of IT Consulting, Engineering Consulting, Healthcare, Talent, and Workforce Management Solutions to Fortune 1000 companies globally. ACS Group conducts business through five operating brands – AIC, Analysts, ComforceHealth, MassGenics, and HireGenics – each with a specialized business focus. Our operating brands have provided targeted services and solutions for more than 50 years. ACS Group has grown to over $700 million in revenue with more than 12,000 employees and consultants worldwide. Recognitions include: #1 Largest Minority-Owned IT Consulting Company in the U.S. (2016 SIA); Inavero’s Best of Staffing® Client Diamond Award (2017). ACS Group is a certified MBE organization, and operating brand, HireGenics, is an NMSDC Corporate Plus® member. Headquartered in Atlanta, Georgia, ACS Group has offices across the U.S., in India, and an international presence in Canada and Latin America.

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