Director, Global Regulatory Affairs, Connected Health (Gardiner)

  • Gardiner, ME

Employment Type

: Full-Time

Industry

: Scientific Research



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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 connected health and device portfolios.. Provide regulatory strategy for assigned products within the company's connected health and device portfolios. 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, Advanced degree in scientific or life sciences discipline or related (PharmD, PhD, MD) strongly preferred.. At least 10+ 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. Actively engages colleagues, interacting broadly with other members of GRA. Preferred. Demonstrated track record of success contributing in a globally oriented environment. 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. EMD Serono is the North America biopharma business of Merck KGaA, Darmstadt, Germany, employing over 1,200 individuals around the country...
Associated topics: aseptic technique, biopharmaceutical, diet, food, healthcare, industrial hygienist, medicine, nephrology, nutritionist, pharmaceutical


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