The Regulatory Affairs Manager position is based in UK or IE.

Who We Are

Alimera Sciences is a pharmaceutical company dedicated to being invaluable to patients, physicians, and partners concerned with retinal health and maintaining better vision for longer.

Alimera employs people in offices in the UK, Germany, Ireland, Portugal and the US, all united in an effort to help patients maintain their vision for longer.

Who are we looking for?

We are seeking a Regulatory Affairs Manager to join our global team based in the UK/IE. This is an individual contributor role with no direct reports.

Do you currently hold a Regulatory Affairs position in the pharmaceutical industry with hands on experience in preparing and managing European and US human drug submissions? Are you experienced in pre- and post- licensing strategies and submissions, including preparation and oversight of technical CMC sections and filings? Interested in a highly visible role which offers a breadth of activities and cross-functional interactions? If so, this may be the ideal opportunity for you! With the recent acquisition of new products and new drug-led combination product requirements, this is an exciting time to join our growing and highly motivating company. This role welcomes independent and creative thinking to achieve business goals and will offer you the opportunity to lead global submissions and be involved with various cross-functional activities to further your development.

Professional Qualifications/Experience

• Degree in life sciences, engineering, pharmacy or higher.
• Minimum 5 years’ experience in European and US Medicinal Regulatory Affairs.
• Practical experience in preparing and managing CMC regulatory affairs strategies and submissions (2+ years).
• Proven ability to accurately assess regulatory impact, develop effective strategies and deliver European and US submissions. Prior experience with MRP/DCP is required.
• Sound performer in interacting with and influencing regulatory authorities.
• Knowledge of medical devices and drug-led combination products is desirable.
  
  

Tasks / Responsibilities

• End to end management of complex global projects and US / European submissions, from developing strategies through to the filing of applications and post-approval implementation.
• Responsible for a range of submissions from initial authorisation applications, variations/supplements, annual reports through to PIP submissions, IND / European clinical trials and educational materials.
• Author high quality Common Technical Dossier (CTD) modules and regulatory technical documents.
• Oversee and support licensing partners in international regions (including Middle East, Asia, Australia).
• Regulatory point of contact for key projects, collaborating closely with multiple cross-functional areas including PV, Quality, Manufacturing, Supply, Clinical, Medical and Marketing.
• Understand, interpret and advise on regulatory legislation and guidance.
• Interact with regulatory authorities to facilitate successful submissions and approvals.
• Input into cross-functional submission documents, e.g. clinical protocols, PSUR, DSUR, PADER, educational materials, quality/manufacturing reports.
• Assist with the management of regulatory labelling texts, including coordination of translations.
  
  

Skills And Competencies

• Effective and influential communicator – you have strong verbal and written skills, able to clearly convey regulatory positions and persuade internal and external stakeholders.
• Broad knowledge of US and European regulatory systems, including relevant current and upcoming legislation
• Demonstrated ability to author regulatory technical and submission documents, including CMC Module 3, Reviewer Guides, Responses.
• You can understand and interpret regulatory legislation and guidance documents.
• Self-motivated, self-reliant and able to work independently - obvious focus on results, with the urge to get things done - a real "can-do" approach.
• Effective networker and team worker – you are able to build effective working relationships with colleagues, external partners and regulatory authorities.
• Strong analytical thinking and problem solving skills – process orientated with good attention to detail. Proven ability to deliver well thought-through and evaluated solutions.
• Sound project management and organizational skills – you are able to effectively plan time and prioritize to achieve goals.
• Flexible approach – able and eager to learn new things, think creatively and laterally, and think outside the box. Willingness to roll up your sleeves and get things done.
  
  

Grow with us

Alimera thrives on an entrepreneurial environment that requires a high degree of flexibility so that the tasks can evolve as the company grows. This vacancy notice should therefore not be considered exhaustive or definitive.

• NO AGENCIES**