To support the expansion of AM-Pharma’s business, we are currently looking for a

Sr. Director Regulatory Affairs (US based)

About the role

At AM-Pharma, the Sr. Director Regulatory Affairs plays an important role in bringing to market our potential life-saving medical treatment. From your base in the US, you will have the opportunity to work together with a team of professionals within our collaborative and positive company culture.

Reporting into the VP of Regulatory Affairs and Quality Management, you will

  • provide US strategic input on new indications & BLA filing and act as US agent for AM-Pharma;
  • support the scientific advice with FDA & EMA; lead IND updates on our CSA-RD and REVIVAL studies;
  • provide regulatory intelligence to the company;
  • oversee all activities regarding the US labelling and promotional review of materials
  • support AM-Pharma in its development, registration and commercialization efforts in China and Japan;
  • prepare for the US pediatric activities, including the preparation of an iPSP resubmission);
  • support the team with developing regulatory strategies, and market access planning
  • bring up-to-date knowledge on regulatory strategies, guidelines, document management and archiving policies and share this with the development team;
  • coordinate and support the interaction with (inter)national health authorities, agency meetings;
  • coordinate the writing and reviewing of scientific and clinical development reports for regulatory compliance;
  • be involved in business development and inlicensing activities.

What we expect

We expect the Sr. Director Regulatory Affairs to

  • 10+ years of relevant strategic regulatory experience in a drug development setting
  • Have the ability to oversee and coordinate multiple tasks efficiently and effectively
  • Have good communication skills with ability to work in a small and professional team environment
  • Have strong interpersonal skills and high attention for detail
  • Be based on the East Coast of the US

AM-Pharma company culture
The company culture of AM-Pharma is built on four important competences. Collaboration, Quality Orientation, Accountability and Resilience. At AM-Pharma we work together in a constructive, collaborative and team-oriented way, towards achieving the company objectives without losing sight of our own objectives. We put the common interest of the company and the patient above our own individual interest. We set high standards regarding the quality of our materials, processes, documentation and collaborations, the staff are motivated to deliver excellence whilst also working to continually improve the quality of our work. We are fully accountable for the things that are in our power and control while working on the goals of the organization. We have an obligation to proactively report, explain and justify the things we do. We accept responsibility for our performance and we are transparent about the results of our work. We understand how to cope effectively with setbacks and obstacles and overcome hurdles on our way to reach our common goal. We stay committed to agreed objectives and company culture despite resistance while having the strength to adjust our plans when necessary. We are tolerant to stress and we deal effectively with criticism and resistance, building on our own strength.

At market level.

Start date
We expect the candidate to start its employment in Q4 2021.

AM-Pharma – East Coast USA

To apply
Please send your CV and cover letter, stating the title of the position you are applying for,

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