Regulatory Affairs Manager(Specialist)

Advanced Recruiting Partners • raleigh, nc, us • 2m ago

Responsibilities

The Global RA Manager supports the Global Regulatory Teams in the translation of regulatory requirements into practical application to ensure the success of pre-approval drug development programs
Supports regulatory agency interactions, communications, and preparation of submissions
Independently coordinates the request to Affiliates and Partners of the regulatory requirements applicable to supported regions or areas of responsibility
With guidance from Unit Head, assist in the identification of the EU and US regulatory requirements applicable to supported regions or areas of responsibility
With guidance from Unit Head, assist in the preparation and presentation of regulatory information at internal project meetings; contribute to global strategy via participation.
With limited assistance, confirm compliance with applicable regulations and guidelines to ensure suitability of regulatory applications for submission
Provide updates to internal documentation, as appropriate
With guidance, provides support to GMP, GCP, and GPV inspections from health authorities
With guidance supports pre-approval and post-approval activities
With guidance maintains relationships with the health authorities, directly or via Affiliate/Partners
With guidance manages IMDD, Affiliate, and Partner relationship(s) to ensure efficient global execution

Qualifications

At least 3 years of experience within Regulatory Affairs
Professional skills needed to hold the position:
General knowledge of the drug development process, drug regulations, regulatory procedures, and drug development guidance
Effective in verbal and written communication
Able to work in a matrix and in multicultural teams
Result-driven
Listen, social intelligence, and diplomatic
Good knowledge of regulatory tools for tracking and archiving
Good knowledge of basic Office programs
Ability to prepare PowerPoint presentations
Ability to search and retrieve information from the worldwide web
University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology
Scientific secondary-school diploma with at least 5 years of experience within International Regulatory Affairs
Written and spoken English

Related Jobs

DRB Group | Warranty Coordinator NC

DRB Group • raleigh, nc, us • 18h ago

18h ago

UNC Health Care | Applications Systems Analyst - Epic OpTime / Anesthesia

UNC Health Care • morrisville, nc, us • 18h ago

18h ago

Duke Health | Nurse Manager, Operations (NMO) - Ambulatory Oncology Clinics

Duke Health • raleigh, nc, us • 18h ago

18h ago

UNC Health Care | Clinical Support Tech I- Medical Surgical ICU (MSICU)

UNC Health Care • raleigh, nc, us • 18h ago

18h ago

Prospect Infosystem Inc. | Java Consultant

Prospect Infosystem Inc. • raleigh, nc, us • 18h ago

18h ago

Accentuate Staffing | Human Resources Generalist

Accentuate Staffing • raleigh, nc, us • 18h ago

18h ago

Adelphi Medical Staffing, LLC | Physician / Family Practice / North Carolina / Permanent / Physician - Correctional Medicine/Urgent Care/Primary Care/FM Job

Adelphi Medical Staffing, LLC • raleigh, nc, us • 18h ago

18h ago

UNC Health Care | Medical Technologist II - Clayton Laboratory

UNC Health Care • clayton, nc, us • 18h ago

18h ago

Schoolforce Solutions | Special Education Teacher

Schoolforce Solutions • raleigh, nc, us • 18h ago

18h ago

Dental Care on Fernwood Drive | Dental Hygienist

Dental Care on Fernwood Drive • clayton, nc, us • 18h ago

18h ago