Michael Page

Senior Regulatory Affairs Director

5 days left

Location
Republic of Ireland
Salary
Negotiable
Posted
13 Apr 2021
Closes
11 May 2021
Ref
JN -042021-2558012
Contact
Chloe Baverstock
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Very exciting and rare opportunity to join a growing and well established pharmaceutical business as a Senior Regulatory Affairs Director.

Client Details

I have partnered with one of the large global pharmaceutical businesses known all across the world. They have exciting and ambitious growth plans over the next 5 years.

Description

You will be responsible for a Product Range Team and lead the Regulatory aspects of Chemistry, Manufacturing and Controls (CMC) for licensed and clinical biological products in development. The primary focus will be on products derived from biotechnology but in addition there will be the opportunity to interact with vaccines.

  • Leads and manages an RA CMC Team
  • Supports Global RA objectives
  • Supports the Head of Global RA CMC Biologics
  • Contributes to global strategy and planning decisions
  • Manages team and develops staff
  • Plan/Prep/Submit/Review support
  • CTA / IND preparation and maintenance
  • BLAs
  • NDAs
  • Recurrent filings: annual reports (US, Canadian NDC and YBPR, license and renewals
  • Post-Marketing Commitments (PMCs) and Other Regulatory Commitments (ex. Stability data, from CTD text
  • Assemble Information, including assigned deliverables
  • Direct frequent face to face meeting with global health authorities
  • Initiate Communication to Responsible Parties and Stakeholders
  • Compile monthly summary update of PMCs and other regulatory commitments related to Sites for CQO
  • Track Internal Progress and assemble final package
  • Submit to Agency/Health Authority/Affiliate
  • Update data management systems
  • Issue Follow-up Communications to Responsible Parties and Stakeholders as necessary
  • Track Agency/Health Authority Progress
  • Close out Commitments in appropriate databases when Agency/Health Authority Indicates it has been fulfilled
  • Communicate Close Out of Commitment to All Parties
  • Point of contact with Global Reg Affairs Product Leads
  • Interaction/liaise with FDA, Health Canada, ANVISA, PMDA and many others on product topics
  • Regulatory strategy development
  • Preparing / Authoring Submissions - US & ROW

Profile

  • Advanced degree (PhD preferred) with 10/15 years' experience.
  • Expert knowledge of EMA and FDA regulations is essential.
  • Solid knowledge of Biotechnology CMC.
  • Previous experience working in a fast paced very high pressure environment on multiple product lines
  • Manufacturing, QA/QC experience a plus
  • Familiarity with vaccines CMC

Job Offer

Generous Package + Great opportunities