Associate Director, Global Regulatory Affairs

<p style="text-align:justify"> </p><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Work Your Magic with us! </span></span></p><p> </p><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we!

Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.

That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. </span></span></p><p> </p><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.

Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.</span></span></p><p style="text-align:justify"> </p><br><p><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="text-decoration: underline;"><strong>Scope:</strong></span> The Regional Regulatory Lead is responsible for the regulatory strategy and execution for their assigned projects in their region / country.</span></p><p><span style="text-decoration: underline; font-size: 10pt; font-family: verdana, geneva, sans-serif;"><strong>Responsibilities include, but are not limited to the following:</strong></span></p><ul><li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Represent and provide input for your respective region at the GRST.

May provide direct input to the GPT in case of major region, particularly where the GRL is not in that region. </span></li><li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Lead the respective regional regulatory sub-team.</span></li><li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Drive the regulatory submission in your respective region. Ensure optimal planning in alignment with cross-functional team, and execution to plan for both development submissions and maintenance submissions to ensure ongoing compliance.

Partner with Regulatory Project Management and Submission Management.</span></li><li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">May act as direct contact to a local HA (e.g. FDA or EMA).

Lead the direct interactions with the respective local HA in this case.</span></li><li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Contribute to the global regulatory strategy with local / regional strategy for assigned projects.</span></li><li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Matrix leadership role of respective Regional Regulatory ST.</span></li><li style="font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Participate in cross-functional and GRA initiatives.</span></li></ul><p style="margin: 0in 0in 3pt; line-height: 115%; font-size: 12pt; font-family: Cambria, serif;"> </p><p style="line-height: 115%; font-size: 11.0pt; font-family: Calibri, sans-serif; margin: 0.0cm 0.0cm 6.0pt 0.0px;"><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="text-decoration: underline;"><strong><span style="line-height: 115%;">Minimum Qualifications</span></strong></span></span></p><ul style="margin-bottom: 0.0cm; margin-top: 0.0px;"><li style="line-height: normal; margin: 0cm 0cm 6pt 0px; font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Advanced degree and at least 5 years of regulatory affairs strategy experience in drug development in the US.</span></li><li style="margin: 0in 0in 0in 0px; font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Demonstrated successful interactions with FDA related to strategy and execution of development and maintenance activities.</span></li><li style="line-height: normal; margin: 0cm 0cm 6pt 0px; font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Experienced strategist with a record of successful HA interactions with FDA or EMA including NDA / BLA activities.</span></li><li style="line-height: normal; margin: 0cm 0cm 6pt 0px; font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;">Demonstrated strong matrix leader.</span></li><li style="line-height: normal; margin: 0cm 0cm 6pt 0px; font-size: 10pt; font-family: verdana, geneva, sans-serif;"><span style="font-size: 10pt; line-height: 115%; font-family: verdana, geneva, sans-serif;">Excellent spoken and written English.</span></li></ul><p style="line-height: 115%; font-size: 11.0pt; font-family: Calibri, sans-serif; margin: 0.0cm 0.0cm 6.0pt 0.0px;"> </p><p style="line-height: 115%; font-size: 11.0pt; font-family: Calibri, sans-serif; margin: 0.0cm 0.0cm 6.0pt 0.0px;"> </p><p><span style="font-size: 10pt; font-family: verdana, geneva, sans-serif;"><strong>Location</strong>: This is an onsite role based in our Billerica, MA facility requiring and onsite presence at least 3 days per week.</span></p><p> </p><p> </p><p> </p><p><span style="font-family: verdana, geneva, sans-serif; font-size: 10pt;"><strong>Pay Range for this position: $135,300 - $202,900</strong>. The offer range represents the anticipated low and high end of the base pay compensation for this position.

The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here: <a href="https://careers.emdgroup.com/us/en/benefits" target="_blank" rel="noopener noreferrer">https://careers.emdgroup.com/us/en/benefits</a> </span></p><br><p> </p><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong>What we offer:</strong> We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.

We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace.

Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!</span></span></p><p> </p><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!</span></span></p>