Regulatory Submissions Document Specialist
Ipsen
Ipsen is looking for a Document Specialist in Cambridge, MA, to support regulatory teams by ensuring high-quality electronic submissions. This role involves training authors and managing documents within an eDMS environment. The ideal candidate will have over 5 years of experience in a CRO or pharmaceutical setting and a bachelor's degree in Life Sciences. The position offers a chance to make an impact in a global biopharmaceutical company. #J-18808-Ljbffr Ipsen
$91.5k - $134.2k
Ipsen Innovation (SAS) seeks a Document Specialist in Cambridge, MA, to support Regulatory and submission teams in electronic regulatory submissions globally. The role involves ensuring documents are completed to high standards and mentoring authors on compliance with...Regulatory- ...Document Specialist Ipsen is a mid‑sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic... ...and society! The Document Specialist will support Regulatory and submission teams to enable electronic regulatory submissions to authorities...RegulatoryWork at officeLocal areaWorldwideFlexible hours
$91.5k - $134.2k
Document Specialist - Ipsen Innovation (SAS) Support regulatory and submission teams by ensuring that documents are completed in high‑quality, ready‑for‑submission (RFS) format within agreed timelines, collaborating with authors and coordinating with regulatory publishing...RegulatoryTemporary workWork at officeFlexible hours- A biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at least 8 years of experience in Regulatory Affairs, particularly with Small Molecule drugs,...Regulatory
- Monte Rosa Therapeutics is seeking a Regulatory Operations Manager in Boston, MA. This role... ...operations with proficiency in eCTD submissions and vendor oversight. The candidate will... ...standards, and prepare submission-ready documents. The position offers an opportunity to...Regulatory
- AVEO Pharmaceuticals is seeking an Executive Director of Regulatory Operations to lead global submission management and ensure compliance and quality across submissions. The role requires extensive experience in regulatory operations and managing high-performance teams....Regulatory
- ...leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing... ...products. The candidate will prepare regulatory submissions, interact with health authorities like the FDA, and ensure compliance...Regulatory
- Monte Rosa Therapeutics, Inc is seeking an experienced regulatory affairs professional in Boston, MA. Responsibilities include coordinating regulatory workflows, compiling submissions to the FDA, and providing ongoing support to project teams. The ideal candidate holds...Regulatory
- EY is seeking a Senior Manager for its Life Sciences Regulatory Submissions practice based in Boston. This role focuses on driving growth and establishing EY as a leader in regulatory compliance. The ideal candidate will have extensive experience in regulatory submissions...Regulatory
$91.5k - $134.2k
Ipsen Biopharmaceuticals Inc. is seeking a Document Specialist to support regulatory submissions by ensuring documents are high-quality and ready for submission. The role requires collaboration with teams and experience in document management within the pharmaceutical environment...Regulatory- Page Mechanical Group, Inc. is looking for an Executive Director of Regulatory Operations and Submission Management. This strategic role oversees the global regulatory processes ensuring high-quality submissions and compliance across the product lifecycle. The ideal candidate...Regulatory
- A biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory support, preparing technical documents, and ensuring compliance with FDA regulations...RegulatoryWork at office
- Ipsen Group is seeking a Document Specialist in Cambridge, MA to support regulatory submissions and ensure documents are submitted in a Ready For Submission (RFS) format. You will be responsible for training authors and managing eDMS properties. The ideal candidate has...Regulatory
- ...team providing strategic, operational, and people leadership. This role involves developing clinical and regulatory documents and coordinating complex submissions. Applicants should have a Bachelor’s degree and over 5 years of relevant experience in the biotechnology or...Regulatory
- JOB TITLE Executive Director, Regulatory Operations and Submission Management DEPARTMENT Regulatory Affairs REPORTS TO Head of Regulatory Affairs... ...technology, submission planning, management, and tracking, document readiness and quality control, publishing, dispatch,...Regulatory
$136k - $170k
...Therapeutics is hiring a Senior Manager, Regulatory Operations in Cambridge, MA. This... ...stakeholders to streamline regulatory submissions and manage timelines effectively. The ideal... ...experience, and expertise with Veeva and document management systems. A competitive...Regulatory- ...decision-making. The successful candidate will apply biostatistical methods and manage analyst teams, with responsibilities in regulatory submissions and data integration. Preferred qualifications include an advanced degree in Biostatistics or a related field and 3-5 years...Regulatory
$148.5k - $214.5k
...development processes within the CMC Dossier Sciences team. This role focuses on leading cross-functional teams and ensuring timely regulatory submissions while leveraging digital tools and AI solutions. Candidates should have at least 5 years of experience in CMC development,...Regulatory- ...Rosa Therapeutics Inc. is looking for a Regulatory Operations Manager in Boston, MA. The selected candidate will manage eCTD submissions and oversee collaboration with external vendors... .... This role demands expert knowledge in document management standards, as well as...Regulatory
$150k - $200k
...a Medical Writing Lead to oversee the creation of clinical documents across drug development stages. The successful candidate will... ...7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge,...Regulatory$177k - $278.08k
Takeda is seeking a Director, Global Regulatory Lead Oncology to oversee regulatory activities for oncology programs in Boston, MA. This role involves managing FDA submissions and setting global regulatory strategies. Ideal candidates will have 8+ years of pharmaceutical...Regulatory- Creative Solutions Services, LLC in Cambridge, Massachusetts is seeking a Regulatory Submissions Lead to oversee publishing activities for IND, NDA, ANDA, and more. The ideal candidate will manage submission processes, ensure quality control, and mentor team members. A...Regulatory
$210k - $255k
...clinical trial data and statistical programming. Ideal candidates will manage project teams, apply biostatistics methods for regulatory submissions, and communicate complex findings effectively. The position also supports mentorship of junior team members, contributing...Regulatory$116.7k - $132k
...Compliance work plan, monitor federal and state regulatory requirements and industry developments,... ...requests, cover letters and supporting documentation as required for delivery to Chief Compliance Officer for final submission to payers Review government and commercial...RegulatoryFull timeWork at officeFlexible hours- ...materials. In this role, you will conduct editorial reviews, verify comments, and facilitate discussions among Medical, Legal, and Regulatory Advisors. Your expertise in English writing, alongside your ability to multitask and meet tight deadlines, will be essential in...Regulatory
- ...collaborating with cross-functional teams, ensuring compliance with regulatory standards, and managing team tasks effectively. The ideal... ...data analysis. Strong communication skills and regulatory submission expertise are essential for success in this position. #J-1880...Regulatory
- Noema Pharma is seeking a Director of Regulatory Affairs to lead the development and commercialization of products in clinical programs. This senior role requires a candidate with strategic leadership skills and over 10 years of regulatory experience in the pharmaceutical...RegulatoryLocal area
$160k - $240k
Rhythm Pharmaceuticals, Inc in Boston is seeking an experienced Regulatory Affairs Operations professional to manage regulatory operations activities and ensure compliance with internal and health authority standards. The ideal candidate will have over 8 years of experience...Regulatory- ...cost. Job Description Tracking and reviewing change control documentation. Assist with the editing of quality documents (SOP's, guidelines... ..., validation master plans, etc.) to ensure compliance with regulatory requirements. Must be able to work quickly with a high...RegulatoryWork at officeImmediate start
- ...Inc. is seeking a Senior Manager for Regulatory Affairs Operations at its Needham, MA... ...involves supporting global regulatory submissions through effective collaboration with cross... ...will have over 8 years of regulatory documentation experience and 5 years in a management...RegulatoryWork at office
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