Regulatory Affairs Manager

A Few Words

About Us

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time.

We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. This position is with my direct client Position Details: Client Direct Client Location Wayne, PA Job Title Regulatory Affairs Manager Duration 6 Months+ Must have skill-set [Job Description]

Job Summary

Responsible for the management and conduct of US regional regulatory activities as directed by and under supervision of manager. Lead regulatory activities for assigned projects in line with US regulatory requirements. Primary

Responsibilities

Include:

• With supervision as appropriate, function as liaison between FDA and company for assigned projects.
• The planning, coordination, organization and preparation of complete high quality regulatory submissions for assigned products, including both pre-approval and postmarketing submissions.
• Ensuring regulatory compliance for all assigned responsibilites.
• Responsible for the implemention of regulatory strategies for the development and maintenance of assigned product or products.
• Maintain up-to-date knowledge and expertise of FDA regulations/guidance documents, and ICH guidelines

Responsibilities

Prepare, compile, review/qualilty control and process regulatory submissions including INDs, BLA, NDA, amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, etc.

• Attend and participate in assigned project/regulatory product development and submission teams, providing clear and consistent regulatory recommendations.
• Coordinate and consult with other departments on the content, quality and assembly of regulatory documentation. Ensure consistency, completeness and adherece to standards for all regulatory submissions.
• Conduct regulatory communications with FDA, under appropriate supervision and direction, for assigned products and activities.
• Coordinate FDA meeting requests, meeting rehearsals, briefing book preparations and preparing meeting minutes of FDA meetings. Education and Experience: BA/B.S in a scientific, healthcare or related field or equivalent experience. Advanced degree preferred, but not required
• 5 -10 years of biopharmaceutical experience with emphasis in regulatory affairs and drug development
• Knowledge of FDA regulations and guidelines on drug development and the approval process for NDA/BLA and postmarketing supplements
• Strong written/verbal communication skills Key Skills:
• Excellent communication skills both written and verbal
• Demonstrates strong ability to collaboratively interact and work effectively with other departments as well as external organiations
• Excellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelines
• Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions Complexity and Problem Solving:
• Under supervision of regulatory management and in conjunction with cross functional team members execute regulatory strategies, develop submission timelines and content plans for regulatory submissions.
• Contribute to the development of specific regulatory content supporting company positions as presented in required regulatory documents. Internal and External Contacts:
• With supervision function as liaison between FDA and company for assigned projects.
• Consults with regulatory management and Global Regulatory Leads on product team related issues, planning and submissions;
• Represents the US strategy regulatory group as well as GRA on assigned product teams including clinical operational study management teams.
• Interacts with cross functional team members, e.g. clinical operations, nonclinical development on development program related issues;
• Works with regulatory operations on the development of regulatory submissions. Feel free to forward my email to your friends/colleagues who might be available Thanks!!! Warm Regards, Amrit Singh Clinical Recruiter Integrated Resources, Inc IT REHAB CLINICAL NURSING Tel: (732) 429 1634 Fax: (732) 549 5549 http://www.irionline.com Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year) Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70