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Job Details

Global Regulatory Labelling Director - US and EU experience - Work 2 days remotely - Central London

Company: Mosaic Regulatory Solutions
Location: London
Reference: LAB3223
Closing Date: 19 Jun 17
Type: Permanent
Salary (£): On Application
Benefits: Excellent

Job Summary:

To apply for this Regulatory Affairs Labelling Director please call Julie Cooper on 07951 082482 or send your CV to: julie@mosaicrecruitment.co.uk

Requirements:

 

Job Title: Director, Global Labeling & Compliance

Location: Central London 

Salary: Negotiable

Hours: Can work two days from home, 3 days in the office

 

Job Summary:

 

·         Responsible for operational oversight and leadership to personnel responsible for  labeling, including point of contact for individuals assigned to GL responsibilities and tasks

·         Develops, implements, and oversees appropriate systems to ensure compliance with external regulatory requirements and internal  standards. Manages day-to-day issues labeling issues. Collaborates with GRA Compliance roles

·         Works cross-functionally to ensure  labeling objectives are met.  Monitors progress, identifies risks, and proposes solutions/improvements.  

·         Recognized as expert in global labeling, EU/US labeling, and Company Core Data Sheet (CCDS)

·         Lead and oversee GL team members who are responsible for:

o    aliging labeling content with regulatory requirements and interacting with global representatives to ensure consistency of CCDS development across the therapeutic areas for which they have responsibility

o    assessing the impact of statements in a regional or local label on the labels for the rest of the world where  markets the product.

·         Ensure adequate LOC support to facilitate timely submission of variations and assess and report metrics demonstrating compliance.

·         Responsible for regulatory and operational oversight of Global Labeling (GL) processes including the preparation of GL sections of the Pharmacovigilance System Master File (PSMF), writing and tracking CAPAs, tracking and compiling GL metrics

·         Provides IT Systems support for GL activities associated with Mosaic, PRISM, EAMS, EQMS and others, as needed

·         Manages GL Continuous Improvement and Monitoring activities such as QMS document authoring, review and management, and Training

·         Mentor and develop skills of staff.

 

                                   

 

Directs and manages Global Labeling and Compliance operations including:
 

·         Establishes and manages relationships to ensure the effective implementation of labelling processes to meet business needs and regulatory requirements.

·         Serves as a bridge between TA labeling personel and , as needed

·         Monitors GL and US/EU labeling activities including processes for CCDS creation and maintenance for Marketed Products (including EPIC), CCDS distribution, tracking and implementation, and USPI/SmPC management and operations

·         Monitors LOC compliance with labeling activities, and supports  PSMF and  inspection/audit activities

·         Identifies and resolves risks, communicates to GL Head

·         Maintains CCDS, US, and EU labelling processes in compliance with government regulations and quality standards to ensure commercial product integrity.

·         Serves as a labeling resource to the Therapeutic Area Unit/Therapeutic Area for labeling issues in that TAU/TA.

·         Develops and proposes new methods to improve the efficiency of Global Labeling

·       

·         Manages the preparation and review of reports of GL compliance, including Escalations regarding the implementation of CCDS information into product labeling to ensure compliance to regulations and  processes

·         Ensures adequate and accurate QMS and supporting process documents to support GL activities; design and conduct necessary Training.

·         Manages preparation activities for audits/inspections, serve as SME, CAPA management

·         Manages the GL Mailbox and GL Sharepoint Site(s) to ensure accurate record keeping in alignment with the  records retention policy

 

 

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be highlighted.)

·         BS/BA degree or advanced scientific or related degree.  Scientific degree preferred.

·         Substantial experience in a regulated environment with broad experience working in the pharmaceutical industry. Prior Labeling experience required.

·         Previous management experience.

·         Knows and understands global standards, FDA regulations and European regulations relative to labeling.

·         Understanding of scientific principles and regulatory/quality systems relevant to drug development. 

·         Demonstrated problem-solving ability  with demonstrated generation of  alternative solutions prior to elevation of issues to management.

·         Excellent oral and written communication skills

·         Demonstrated analytical and problem solving skills

·         Strong organizational skills and demonstrated attention to detail

·         Ability to work across organizations and to both direct and work in a team environment

 

 

 

 

TRAVEL REQUIREMENTS:

·         Willingness to travel to various meetings, including overnight trips. Some international travel may be required.

·         May require up to 20 % travel.

 

Key words / key word: regulatory affairs labelling#regulatorylabelling#labelling#regulatoryaffairs#london#FDA#EU#

#CCDS#CAPA#Compliance#Flexibleworking#GlobalLabelling#Director#LabellingDirector

Apply for this job: Global Regulatory Labelling Director - US and EU experience - Work  2 days remotely - Central London

Contact Information:

Address:  Mosaic Regulatory Solutions Ltd
London
SE10
England
Tel:  0208 305 9733
Website:  Visit Our Web Site

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