Director, Global Regulatory Strategy

Summary:

This is a highly strategic role focused on guiding regulatory activities throughout the product lifecycle, from clinical development through registration and post-approval maintenance. You'll partner with cross-functional global teams, interact with regulatory authorities, and shape regulatory strategies that support successful development and commercialization of innovative therapies.

Responsibilities:

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• Develop and execute regulatory strategies for neurology development programs
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• Lead and manage Clinical Trial Applications (CTAs), regulatory submissions, variations, and lifecycle activities
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• Serve as the key regulatory representative on cross-functional project teams
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• Interact directly with European regulatory authorities and lead Scientific Advice procedures
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• Provide strategic regulatory guidance throughout development and commercialization
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• Monitor evolving regulatory requirements and assess impact on development programs
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• Support global submissions and regulatory interactions
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• Contribute regulatory intelligence and competitive insights to project teams
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Requirements

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• Bachelor's degree in a scientific discipline (advanced degree advantageous)
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• Extensive Regulatory Affairs experience within the biotech or pharmaceutical industry
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• Strong experience with Clinical Trial Applications (CTA) and regulatory submissions
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• Proven experience interacting with European regulatory authorities
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• Strong understanding of pharmaceutical development, registration, and lifecycle management
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• Experience developing regulatory strategies for clinical-stage and marketed products
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• Excellent project management and stakeholder management skills
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• Strong written and verbal communication skills
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• Strategic mindset with strong problem-solving abilities
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Preferred Skills:

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• Experience in Neurology or other specialty therapeutic areas
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• Experience acting as a Global Regulatory Lead
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• Knowledge of Paediatric Investigation Plans (PIPs)
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• Experience supporting global development programs across multiple regions
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• Ability to influence cross-functional teams within a global environment
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ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognized by FORBES as the 17th best professional staffing firm and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

TO APPLY

Please click ‘apply’ or contact Joesela Alolod A. (Recruitment Sourcer) at Planet Pharma for more information:

E: [email protected]

T: +61 370580550

Linkedin: www.linkedin.com/in/joeselaaloloda/