Global Regulatory Affairs Leader

Discipline: Regulatory Affairs
Contact name: Katie Dunbar

Contact email: katie.dunbar@rbwconsulting.com
Contact phone: +44 1293 584 300
Job ref: 22451
Published: 3 months ago
Expiry date: 11 February 2022

RBW Consulting are recruiting exclusively for a Global Regulatory Affairs Leader on behalf of a biotech. They are building a pipeline of novel therapies, designed to modulate the chemical imbalances that drive disease. By leveraging their unique protein engineering expertise to develop human enzyme medicines, they are able to help people with rare and devastating metabolic diseases who otherwise have limited treatment options.

 

They are seeking a Global Regulatory Affairs Leader. This role provides strategic direction, oversight and management of assigned Regulatory Affairs activities, aligning department and project objectives with overall pipeline objectives and reporting directly to the Vice President of Global Regulatory Affairs.

The position is based remotely, working from home in either the USA or UK, with less than 10% domestic and international travel required.  

Key responsibilities of the role:

  • Act as the subject-matter expert on assigned Regulatory Affairs activities.  Lead regulatory assignments with a sense of urgency and commitment to providing safe and effective products to patients with rare and devastating metabolic diseases
  • Participate in cross-functional teams in preparing Target Product Profiles and development plans. Ensure all aspects of the development plan comply with  US and ex-US regulatory requirements
  • Compile, edit, prepare final Regulatory submissions, including oversight/leadership of appropriate support staff. This includes writing introductory or bridging sections and conclusions to produce a cohesive document (NDAs, BLAs, INDs, CTAs, annual reports, protocol amendments, adverse event reports, notifications, and other reports) in accordance with global regulatory procedures and guidelines
  • Lead and collaborate with other development departments and external partners in writing reports and summaries. Leading other staff to ensure they meet regulatory requirements in structure, data and presentation
  • Support the VP of Regulatory Affairs in leading regulatory communications with external stakeholders, development and business partners (e.g., investors, legal, nonclinical, statistical, market access specialists and vendors and consultants)
  • Collaborate with a variety of technical and medical experts to provide input into and support to drug research and development pipeline
  • Support the VP of Regulatory Affairs in performing due diligence activities as appropriate.  
  • Support the Vice President of Regulatory Affairs in developing and adhering to operational budgets for all programs

Essential experience we’re looking for….

  • Advanced degree in life sciences and minimum 6 years of regulatory experience in the biotechnology or pharmaceutical industries. 
  • A solid history of bringing small molecule or biologic to IND/CTA phase and BLA/NDA/MAA submission phases and commercialization. Rare disease/orphan drug experience preferred
  • Extensive experience in the organization, preparation, submission of INDs, CTAs, EU PIP, BLAs, NDAs, and MAAs
  • Extensive regulatory background with demonstrated ability in leading interactions and negotiations with the FDA, EMA, and other health authorities worldwide
  • Proven ability to provide regulatory leadership and expertise within a cross-functional, team-based environment
  • Experience developing regulatory strategies and an understanding of product development required

 

…and the required skills to succeed

  • Technical expertise- an advanced understanding of the drug development process, of the principles, concepts and theories of Regulatory Affairs and those of other close disciplines
  • Excellent written and verbal communication skills
  • Demonstrated ability to build strong external relationships and act as liaison with regulatory agencies and partners on drug development matters
  • Internal teamwork and collaboration- ability to develop and leverage constructive relationships across disciplines and functions, maintains productive working relationships with cross-functional study team members
  • Effective decision-making skills- developing multiple innovative solutions to resolve complex problems
  • Ability to work independently using knowledge, foresight and experience in ambiguous situations
  • Ability to communicate to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and progress against milestones.
  • Champions innovation to drive business improvement within the function

 

This is a small, high-growth, fast-paced organization. The ability to be productive and successful in a scientifically led and data driven work environment is critical. 

 

The salary and package on offer are very generous, and this is a small and energized team, who will support each other to ensure the best outcomes for patients.

 

Please apply today or contact Katie Dunbar on +441273 952176 for more information.