Senior Manager, Regulatory Affairs

San Mateo, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

About Aerogen:

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 MedTech 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 #discoverbetter.

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

Bachelors 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

What is it like to work at Aerogen

Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages and we are here to support our global team with a range of financial and non-financial rewards and benefits. Theres something for everyone! Here is an idea of what we offer:

Competitive bonus plan.
Above market life insurance.
Opportunities for development and professional growth.
Aerogen Connect our employee-led program that helps our global teams unite and have fun.
We donate 1% of profits and time to charities and organizations.

Visit our careers website for more information about life at Aerogen.

Aerogen is committed to promoting diversity inclusion and equality in the workplace. If you have difficulty using our application process please contact us via email at emailprotected. Please provide your name and preferred contact method.

Required Experience:

Senior Manager

About Aerogen: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 MedTech awards and ten-time winner of the Zenith award for Respiratory Care Excellence in North Ame...