- Lead and oversee a new, small RA international teams, providing leadership and regulatory strategic guidance ensuring successful and timely regulatory submissions
- Lead the preparation, submission, and approval of regulatory filings (new product registrations, existing product global expansion registrations, variations and other lifecycle regulatory activities) for the companies identified international markets with a portfolio of assets.
- Manage existing product dossier updating and remediation activities supporting global expansion of existing products into new markets- emerging markets/ LATAM and JPAC
- Liaise with country affiliate and distributor RA teams providing support for regulatory submissions, labelling and post approval submissions, and ensuring regulatory compliance
- Provide updates to senior leadership on regulatory submission activities as needed
- Analyse evolving global regulations, trends, and competitive landscapes within the EMEA international region
- Manage the product lifecycle, including Marketing Authorization submissions, (DCPs, MRPs), set up and implement post-approval line-extension and variation strategies, maintenance activities.
- Educated to degree or advanced degree in related life science field
- Significant Regulatory experience – 10 years plus – including strategic leadership and global experience in international markets
- Regulatory experience of Latin America and Asia countries is essential
- Experience managing regulatory registrations for existing products for global expansion
- Proven success in the effective management of timely approval of regulatory procedures in emerging markets
- Broad understanding of the requirements to place products on the market within EU
- The successful candidate will be an agile, autonomous and a leader, who wishes to be hands on and grow a new department
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Director Global Regulatory Affairs - England - Blackfield Associates
Description
Blackfield Associates are proudly partnered with an international pharmaceutical client on an exclusive basis, who are looking to establish a new team for their emerging markets division. To lead this team, we're looking to hire a Regulatory Director to ensure successful registration, lifecycle management and global expansion of the portfolio, while providing leadership to a small team and working closely with affiliates and international stakeholders.
As Regulatory Affairs Director, you will:
To be considered for the role of Regulatory Affairs Director, you will:
This is a permeant, full time role. Based from the companies affiliate office, you will need to be able to attend the Slough office on a hybrid basis.
Unable to sponsor, candidate must have full right to work in the UK and flexibility around working hours due to territories.
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Regulatory Affairs
Only for registered members London
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Regulatory Affairs
Only for registered members London
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Regulatory Affairs
Only for registered members London, England
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Regulatory Affairs
Full time Only for registered members City of London
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Regulatory Affairs
Only for registered members London
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Regulatory Affairs
Only for registered members London
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Regulatory Affairs Analyst
Only for registered members London
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Regulatory Affairs Consultant
Only for registered members London
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Regulatory Affairs Manager
Only for registered members London
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Director, Regulatory Affairs
Only for registered members Uk, United Kingdom
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Regulatory Affairs Manager
Only for registered members London
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Regulatory Affairs Associate
Only for registered members London
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Regulatory Affairs Specialist
Only for registered members London
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Regulatory Affairs Specialist
Only for registered members London Area
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Director, Regulatory Affairs
OTHER Only for registered members London
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Regulatory Affairs Officer
Only for registered members London
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Regulatory Affairs Manager
Only for registered members London
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Director, Regulatory Affairs
Only for registered members London
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Regulatory Affairs Analyst
Only for registered members London
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Regulatory Affairs Manager
Only for registered members London
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EMEA Regulatory Affairs
Only for registered members London