Regulatory Submissions Manager

Planet Pharma are currently partnered with a leading biotechnology company who are at the forefront of innovation in developing life-saving treatments. Their commitment to excellence and patient care drives their mission to bring transformative therapies to global markets. They are seeking a highly skilled and experienced Regulatory Project Manager to join their dynamic Regulatory Affairs team.

The Regulatory Project Manager will be responsible for planning, managing, and overseeing global regulatory submission activities across the product lifecycle, ensuring compliance with international regulatory requirements. The ideal candidate will bring expertise in global submission planning, cross-functional team leadership, experience with rare disease and biological development and a strong background within the biotechnology or pharmaceutical industry

Key Responsibilities:

• Develop and execute comprehensive global regulatory submission plans for investigational and marketing applications (e.g., IND, NDA, BLA, MAA) in collaboration with cross-functional teams.
• Manage timelines, resources, and deliverables to ensure on-time submission and regulatory compliance.
• Coordinate and lead cross-functional project teams, including regulatory, clinical, quality, and manufacturing teams, to deliver high-quality regulatory submissions.
• Serve as the primary point of contact for health authorities and regulatory agencies, ensuring clear communication and compliance.
• Monitor and interpret global regulatory guidelines and trends to anticipate potential impacts on submission strategies.
• Maintain project documentation, track progress, and prepare status reports for senior management and stakeholders.
• Identify and mitigate project risks, ensuring alignment with business objectives and regulatory requirements.

Qualifications and Experience:

• Bachelor's degree in life sciences, pharmacy, or a related field (advanced degree preferred).
• Extensive experience in regulatory project management within the biotechnology or pharmaceutical industry.
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  Must have extensive MS Project experience
  
  
• Proven track record of managing global regulatory submissions and working with health authorities in multiple regions.
• Strong knowledge of regulatory requirements and submission formats (e.g., eCTD).
• Excellent project management skills, with the ability to prioritize, manage timelines, and deliver results in a fast-paced environment.
• Exceptional interpersonal and communication skills, with a collaborative and proactive approach.
• Certification in project management (e.g., PMP) is a plus.

If interested, click Apply or contact Jack Pearne at Planet Pharma for more information:

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.