Associate Director, Regulatory Operations - Boston, MA

+The OpportunityIf you're energized by solving complex problems, digging into details, and playing a direct role in protecting a firm from financial and regulatory risk, this is the role for you. · ...

The Clinical and Translational Investigation Program (CTIP) was established in 2010 to centralize and standardize conduct of clinical research within the Dana-Farber/Boston Children's Cancer and Blood Disorders Center.The Regulatory Operations Manager will oversee the CTIP Regula ...

The Clinical and Translational Investigation Program (CTIP) was established in 2010 to centralize and standardize conduct of clinical research within the Dana-Farber/Boston Children's Cancer and Blood Disorders Center. · The Regulatory Operations Manager will oversee the CTIP Reg ...

Our client is seeking an experienced Regulatory Operations Consultant to support Veeva Vault RIM. · ...

We are seeking an experienced Regulatory Operations Consultant to support Veeva Vault RIM. · This role will play a key part in submission readiness. · ...

+Job summary+Company Overview · Rhythm is a global commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases.+ · +Responsibilities And Duties+Manage regulatory operations activities ensur ...

We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. · Manage regulat ...

The Associate Director of Regulatory Operations is responsible for assisting the Head of Regulatory Operations in maintaining Rhythm's regulatory submission standards and current electronic submission guidelines/requirements. This role involves managing the preparation of eCTD su ...

We're hiring a Senior Analyst, Regulatory Operations to join our Regulatory team. · ...

· Company Overview · Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide m ...

The Associate Director of Regulatory Operations is responsible for assisting the Head of Regulatory Operations in maintaining Rhythm's regulatory submission standards and current electronic submission guidelines/requirements. · The role involves managing the preparation of eCTD s ...

The Sr.Regulatory Analyst is an important member of the Regulatory Operations team responsible for project managing and supporting discrete tasks to ensure Oscar is compliant with federal and state product filing requirements. · Manage the preparation and filing of Oscar's commer ...

+The Associate Director, Regulatory Operations role will be responsible for daily operational activities within Regulatory Affairs to ensure delivery of timely, accurate and high-quality submissions to regulatory health authorities. · +Responsible for forward planning of publishi ...

The Associate Director of Regulatory Operations will lead strategy, infrastructure, and execution for all regulatory submissions (INDs, CTAs, NDAs), ensuring timely, compliant filings with health authorities (FDA, EMA, · APAC HAs) by managing teams, · processesystems(eCTD)and cro ...

The Associate Director Regulatory Operations will be responsible for submission management across the development pipeline and support the commercial portfolio. · This hands-on position will also assist with regulatory affairs systems applications and tools including supporting s ...

+The Executive Director leads the teams of publishing submission management regulatory information management compliance and the regulatory management office responsible for creating a high-quality organization utilizing technology process project management to deliver global sub ...

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines that unlock high-impact protein targets long-considered undruggable. · Strategy & Leadership: Define vision for Regulatory Operations, build scalable infrastructure, me ...

The Executive Director of Global Regulatory Operations leads teams responsible for publishing submissions management regulatory information management compliance. · This role will be accountable for creating high quality organization utilizing best technology process project mana ...

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enGene is seeking a highly motivated and detail-oriented Senior Manager, Regulatory Affairs Operations to join our team. · Lead the day-to-day regulatory operations activities across assigned programs ensuring timely high-quality submissions to global regulatory agencies FDA EMA ...