Regulatory Affairs Manager

Job Description

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. 

Qualifications

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.

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Additional Information

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)

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