Senior Manager, Regulatory Affairs

Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple Med Tech awards and ten-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries.

Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care.

Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discover better.

The Senior Manager, Regulatory Affairs will develop and execute submission delivery plans for global regulatory submissions such as IND annual reports, clinical trial applications, orphan drug designations, Biologic License Applications, CE marking and other marketing applications. The role will assist with health authority interactions on CMC topics, for global, late-stage investigational products including INDs, IMPDs, clinical trial applications, and marketing applications.

The person will serve as the regulatory representative on the clinical trial team and manage all regulatory submissions to maintain regulatory approvals for study execution and adverse event reporting.

• Develop and execute submission delivery plans for global regulatory submissions such as INDs, CTAs, orphan drug designations, BLAs, CE marking and other marketing applications.
• Implement regulatory strategies in collaboration with leadership to ensure introduction of new products into target markets in alignment with product launch goals.
• Ensure timely responses to health authority questions.
• Assist with regulatory meetings and preparation of briefing materials.
• Identify regulatory risks and changes to the project plan and then propose mitigations.
• Monitor evolving regulations and communicate implications to stakeholders.
• Partner with Clinical, CMC, Quality, and Commercial teams to align regulatory strategies with business objectives.
• Collaborate with Clinical and Pharmacovigilance teams to ensure INDs and CTAs are maintained and adverse event reporting is compliant with global regulations.
• Work closely with cross-functional teams as the Regulatory Affairs representative to ensure successful project outcomes.

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biology, or related field required. Regulatory Affairs Certification (RAC) a plus.
• 5+ years in Regulatory Affairs within pharma, biotech, or medical devices.
• Strong project management skills with the ability to manage multiple projects simultaneously.
• Proven ability to manage, submit, and achieve regulatory approvals for complex drug-device combination biologic products.
• Onsite requirements: candidates are expected to be in the office 3 days per week.

• Experience with complex biologic/medical device combination product or surfactants is desirable
• Knowledge of global regulatory guidelines with a demonstrated ability to apply this information to submission planning and clinical trial execution
• Experience in major filing activities such as NDA/BLA/MAA, significant manufacturing changes, or key health authority interactions (such as EOP2 or scientific advice meetings)
• Problem-solving skills
• Strong sense of planning and prioritization, and the ability to work with all levels of management

Our purpose is to transform patient lives and our ethos is to #discover better. This also translates to how we look after our people. We want talented, passionate and engaged people to join…