My client, a biotech based in Central London, are seeking an Associate Director for Regulatory Affairs Strategy. This person will be responsible for the regulatory strategy of development programs and marketed products. This role will serve as a global regulatory lead, or sometimes a regional regulatory lead. Therefore, it requires an advanced understanding of regulatory affairs frameworks in the US, Europe, or other international markets, as well as drug development, and related concepts, and the ability to translate this knowledge into effective regulatory planning and strategy development.
Leads the development and implementation of global regulatory strategy for assigned projects in development through to commercial stages
Contributes to or leads the development and implementation of regional regulatory strategy to inform the global strategy for certain projects
Leads regulatory communications and interactions with health authorities
Advises teams on regulatory requirements for development and approval pathways, including potential for expedited pathways
Leads and oversees the process for preparation, submission, and approval of regulatory applications
Provides strategic and technical regulatory input for key product development or registration documents
Ensures compliance of regulatory submissions with current regulations and guidance
Reviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategy
Advises cross-functional teams and senior management on regulatory risks, considerations, and strategies for programs
Acts as an advisor and coach to mentor members of the team
Education and Experience Required:
Bachelor's degree in Biology, Chemistry, or other related disciplines
Advanced degree preferred, including Doctorate of Pharmacy
Requires extensive relevant pharmaceutical or biotech industry experience within regulatory affairs
Experience working within Rare Disease therapeutic areas would be highly advantageous.
Knowledge and Skills:
Specialized knowledge of global and regional regulatory affairs frameworks and guidelines
Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology
Comprehensive understanding of requirements and processes to maintain a product on the market, product labelling, reporting, and surveillance
Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment
Strong problem-solving skills
Strong written and verbal communication skills, tailored to multiple audiences, to communicate difficult concepts and persuade others to adopt a different point of view
Ability to effectively lead and work within a team environment
Prior experience with major health authority submissions and health authority interactions is required.
This client are a top employer, with highly generous remuneration and benefits package, including great bonus, car allowance, travel allowance, LTIs/share options, and enhanced holiday. They are looking to bring in great people who can develop a long-term career, and there is a structured approach to development and career planning to enable this. They will need office presence in London 3 days per week, with 2 days working from home.
If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.
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