87 days ago on jobs.celgene.com

Manager, International Regulatory Affairs

Celgene Switzerland SA

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Manager, International Regulatory Affairs

Manager, International Regulatory Affairs

Req #:16001632
Location:BOUDRY, NECH
Job Category:Regulatory Affairs
Work Location:Boudry, Switzerland Route de Perreux 1 Boudry 2017
Organization:Celgene R&D Sarl
Schedule:Full-time
Shift:Day Job
Employee Status:Regular
Job Type: Standard
Job Level: Manager
Travel:Yes, 15 % of the Time
Other Locations:Stockley Park, UK 1 Longwalk Road Stockley Park Hillingdon UB11 1DB
Description

SUMMARY

Contributes to development of submission strategy for projects assigned

Responsible for building  regulatory dossiers to achieve timely regulatory approvals & maintenance of the existing portfolio.

 

Core Responsibilities

• Contributes to development of submission strategy for projects assigned

• Provides input  to project teams during the development of regulatory plans & filing strategy to ensure acceptable labelling in markets assigned

• Establish within country, cross-product submission plan in association with  Global/Regional Regulatory Lead, Regulatory CMC, commercial, affiliates &/or marketing partners

• Creates Content Plans to allow publishing & timely dossier submission.

• Responsible for building quality regulatory dossiers.  Works with other functions as necessary

• Act as contact person in RA EMEA for local partners & affiliates  as required 

• Lead the organisation in the preparation of  answers to questions from regulatory authorities.

• Responsible for ensuring that Celgene fulfils Regulatory Authority commitments.

• Ability to lead complex regulatory submissions  for assigned projects

• Responsible for  tracking all activities & for accurate submission plans in eQRMS and communicating any emerging issues to stake holders in a timely manner.

• Ensures that copies of regulatory documents are archived appropriately

• Can identify when to escalate issues to line management & knows when to seek advice.

• Proposes process improvements to manager. Shares best practice involving International regulatory submissions.

• Good understanding of high level strategic issues & implications of Company Core Data Sheet & Regulatory CMC.

 

*LI-SL1

*MOEU

Qualifications

Key Requirements/Knowledge

• Bachelor’s degree in a scientific discipline or equivalent

• Experience of leading International Regulatory Affairs (RA) submissions

• Strong understanding of International regulatory landscape & required approaches/strategies.

• In-depth knowledge of regulatory requirements for countries assigned and good working knowledge of requirements across International region

• Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required.

• Understands constitution of CTD modules; non-clinical, CMC, Clinical

• Understanding of commercial goals and strategy for International region

 

Competencies/Skills

• Takes initiative for professional development & seeks opportunities to learn from others

• Communicates complex ideas effectively across a culturally diverse environment  & with Regulatory Authorities when tasks have been delegated

• Communicates effectively  with Regulatory Authorities when tasks have been delegated

• Ability to influence internal stakeholders

• Effective project manager. Delivers quality projects in accordance with timelines. Prioritises tasks appropriately, coordinates the delivery of multiple projects

• Must be flexible & adaptable to changing project priorities & work assignments

• Displays a willingness to challenge the status quo & take calculated risks

• Understands contributions of other departments & external stakeholders

• Understands & utilises knowledge of local regulations & business practices when working across cultures

• Ability to travel

 

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