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Senior Manager Commercial Regulatory Affairs
Headquartered in the vibrant city of Galway, 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 eight-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 16 million patients in over 75 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?
Due to the global expansion of our business, we are recruiting for a newly created position of Senior Manager Commercial Regulatory Affairs at our headquarters in Galway. The person will be responsible for leading the Commercial Regulatory Affairs team comprising of Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists and Associate Regulatory Affairs Specialists. The role will collaborate with the commercial team ensuring the commercial strategy is supported and executed and work closely with the Engineering and Operations team on commercialisation aspects following regulatory approval.
This role can be office (Galway) or hybrid based. Travel between Aerogen sites in Ireland (Galway and Shannon) will be required from time to time.
What are the key responsibilities?
• Lead, develop, coach and mentor the regulatory team of senior specialists, specialists, and associate specialists.
• Support the team with their career develop plans.
• Ensure the team meet the goals and objectives set by the business.
• Support the commercial strategy for the business:
• Attend the commercial regional meetings, representing the regulatory function.
• Provide inputs to the commercial meetings ensuring our commercial partners are kept informed of regulatory changes and challenges for specific countries and/or regions.
• Provide prompt and accurate advice to our commercial partners.
• Provide mitigation plans for risks that may be present in the business
• Ensure renewals are completed on time.
• Provide inputs to distributor agreements
• Ensure authorised representatives are established where required and provide inputs to those agreements.
• Confidently communicate with regulators and/or local agents regarding Aerogen submissions.
• Ensure Aerogen ships product to regulatory approved countries utilizing the ERP system for those controls.
• Provide inputs to the Integration Partners agreements.
• Support the integration partners to ensure they successfully register the Aerogen product incorporated into their equipment.
• Support the marketing team with promotional material review and release.
• Ensure the materials follow regulatory requirements.
New Product Development:
• Support the R&D, Operations and Manufacturing Teams through the stage gates of the new product development process.
• Support the R&D, Operations and Manufacturing Teams through the stage gates for sustaining changes.
• Support on site audits, internal and external.
• Provides inputs to management review.
• Ensure compliance to global regulatory requirements.
What education & experience are required?
• Degree Level in Law, Engineering, Technology, or Science.
• Masters Degree Level in Regulatory Affairs or other similar discipline is desirable.
• 10 years’ experience in a regulated medical device or pharmaceutical company
• 3+ years in a managerial/leadership position in a regulated medical device or pharmaceutical company.
• Thorough understanding of global regulatory challenges and emerging regulations.
• Usability and electrical medical device experience is advantageous for this role.
• Excellent verbal and written communication, planning and co-ordination skills including strong presentation skills.
What key skills will make you great at the role?
• Ability to demonstrate good business acumen, an understanding of business requirements, identification of and mitigating risks, managing change and working with business partners to grow and develop Aerogen.
• Highly collaborative, team-work orientated and solutions driven with an innovative outlook.
• Strong understanding of strategic alignment and effective organisation and co-ordination skills.
• Ability to effectively lead the Commercial Regulatory Affairs department with integrity to meet objectives while working collaboratively across departments in a strong growth phase.
• Ambitious role model who will enjoy inspiring their team and wider teams to achieve goals and objectives.
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 you to love working at Aerogen and to 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. There’s something for everyone! Here is an idea of what we offer:
• Excellent medical care.
• Bonus & Pension.
• ‘Aerogen Connect’ – our employee led programme which supports our global teams to unite and have fun.
• We pledge 1% of profits and time to charities and organisations.
Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing firstname.lastname@example.org. Please include your name and preferred method of contact.
Ireland - Galway/Shannon
Senior Manager Commercial Regulatory Affairs