- $98,970.00 -156,660.00/year*
24 Bow St
This role has flexibility to be based in Rockland, MA or Billerica, MA.. Your Role:. Responsible for developing and leading Global regulatory strategies for submissions and approvals of clinical trials and original marketing applications for products within the EMD Serono combination product and device portfolios.. Provide regulatory strategy for assigned products within the EMD Serono device portfolio. Support organizational readiness for MDR implementation. Identify and execute on opportunities to build a relationship of trust, scientific credibility, and partnership with relevant internal and external stakeholders (such as health authorities) leading to early engagement to accelerate development. Work effectively in the broader matrixed organization to deliver an aligned and successful regulatory strategy. Ensure compliant and timely operational execution of all required regulatory updates, submissions, and reporting responsibilities. Who you are:. Required:. Bachelor's Degree in scientific or life sciences discipline or related required.. 5+ years in device regulatory affairs. Proven track record of effective collaboration with the regulatory authorities, demonstrated ability to act as a credible, influential, respected spokesperson during interactions. Ability to negotiate within a highly matrixed environment to deliver complex messages and facilitate appropriate team decisions, insightful and forward thinking, ability to recognize, anticipate and proactively manage regulatory needs. Skilled in presenting management with recommendations that reflect full consideration of available options and a strong business judgement on balance of risk. Communicate with clarity, impact, and passion tailored to the audience. Preferred:. Advanced degree in scientific or life sciences discipline or related (PharmD, PhD, MD) strongly preferred.. Actively engages colleagues, interacting broadly with other members of GRA. Demonstrated track record of success contributing in a globally oriented environment. EMD Serono is the North America biopharma business of Merck KGaA, Darmstadt, Germany, employing over 1,200 individuals around the country...
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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