What are the responsibilities and job description for the Senior Manager Regulatory Affairs position at Aerogen Pharma?
About Aerogen Pharma:
Aerogen Pharma is a US based clinical-stage specialty pharmaceutical company with a mission to develop inhaled drug/biologic and device combination that will transform the standard of care for acute and critically ill patients. Our goal is to create medically superior, proprietary and commercially differentiated combination products by combining proven therapeutic molecules with a unique, high-performance aerosol delivery system.
We are embarking on an exciting and dynamic stage in our combination product development, moving into phase 3 clinical trial for one of the biggest breakthroughs in Neonatal care. We are a team of passionate industry experts who are leading, shaping, and driving a potentially transformative medical breakthrough for the treatment of neonatal respiratory distress syndrome (RDS) in the developed world. Additionally, in partnership with The Bill & Melinda Gates Foundation, we have an ambitious program in development to bring low-cost surfactant to the millions of premature babies with RDS born each year.
Join us as we embark on this breakthrough and become inspired to deliver.
What is the role?
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.
What are the key responsibilities?
- 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.
What education and experience are required?
- 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.
What key skills will make you great at the role?
- 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
Why Aerogen Pharma?
As a key member of Aerogen Group, the global market leader in high performance aerosol drug delivery, Aerogen Pharma is at a pivotal point in the company's life cycle. With plans to expand and centralize our US hubs over the next two years, we offer an environment where you can thrive professionally and learn from driven industry leaders in drug development and commercialization, inhaled devices, and neonatology.
We foster an inclusive culture that empowers you to contribute to the transformation of Neonatal care, where potential is recognized, and professional development is encouraged.