We are seeking a Regulatory Affairs Manager to join our global team based in Hampshire, UK.
The Regulatory Affairs Manager role offers you an exciting opportunity to join our highly motivated Product Development – Injectables team, a patient-centric, fast paced environment focused on rare diseases. This position operates within Alimera Sciences Limited, a subsidiary of ANI Pharmaceuticals, with a 3 day per week in office expectation. If you are a regulatory professional with European experience who is looking to expand and grow in their career, then this could be an excellent opportunity for your development! It is a global role, with a primary focus on our international (non-US) markets, which will provide opportunity for you to expand your international and US regulatory experience across a wide breadth of projects and submissions. The successful candidate will be responsible for leading regulatory activities for international projects, providing regulatory guidance and liaising with external partners including regulatory authorities. This role is a key member of a highly visible team and provides prominent exposure across multiple business units and with leadership. As a dynamic growing company, this role values accountability, adaptability and a proactive mindset to support the company’s expansion.
TASKS / RESPONSIBILITIES
- End to end management of complex global projects and submissions, from developing strategies through to the filing of applications and post-approval implementation.
- Oversee and support licensing partners in international regions (including Middle East, Asia, Australia).
- Responsible for a range of submissions from initial authorisation applications, variations/supplements, annual reports through to clinical trials and educational materials.
- Regulatory point of contact for key projects, collaborating closely with multiple cross-functional areas including PV, Quality, Manufacturing, Supply, Medical and Marketing.
- Understand, interpret and advise on regulatory legislation and guidance.
- Interact with regulatory authorities to facilitate successful submissions and approvals.
- Author high quality Common Technical Dossier (CTD) modules and regulatory technical documents.
- Input into cross-functional submission documents, e.g. clinical protocols, PSUR, DSUR, PADER, educational materials, quality/manufacturing reports.
- Management of regulatory labelling texts, including coordination of translations.
PROFESSIONAL QUALIFICATIONS/EXPERIENCE
- Degree in life sciences, engineering, pharmacy or higher
- Minimum of 5 years experience in European Medicinal Regulatory Affairs.
- Proven ability to accurately assess regulatory impact, develop effective strategies and deliver submissions. Prior experience with European MRP/DCP is required.
- Excellent written and verbal communication skills in English.
- Experienced at authoring regulatory technical and submission documents.
- Proven track record with navigating post-approval CMC changes, including ability to identify regulatory impact, data requirements and achieve successful filings.
- Sound performer in interacting with and influencing regulatory authorities.
- Prior US medicinal regulatory affairs experience and familiarity with global regulations, including US, is beneficial but not required. Knowledge of medical devices and drug-led combination products is desirable.
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 European regulatory systems, including relevant current and upcoming legislation
- You can understand and interpret regulatory legislation and guidance documents.
- Self-motivated, self-reliant and able to work independently in a fast-paced, deadline driven environment.
- 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, with a high 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.