Regulatory Operations Coordinator
3 weeks ago
Piper Companies is looking for a Regulatory Operations Coordinator to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA . Responsibilities for the Regulatory Operations Coordinator include: Work with internal teams and stakeholders to build IND & CTA dossier content plans and routine regulatory submissions Lead interactions with publishing team to assemble IND or CTA submissions including annual reports, safety reports, protocol amendments, etc. Support authoring and manage document workflows for planned major submissions Qualifications for the Regulatory Operations Coordinator include: B.S. degree with 3 years pharmaceutical/biotech industry experience including 2 years regulatory affairs or regulatory operations experience. Experience supporting regulatory submissions and managing document authoring and review workflows. Global Regulatory submission experience Detail-oriented with expertise in FDA submission requirements and regulatory document authoring standards. Compensation for the Regulatory Operations Coordinator include: 6-12 month consulting assignment, opportunity to extend/convert thereafter Full Cigna Benefits: Medical, Dental, Vision 2 weeks PTO, 6 Paid Holidays, 401k Keywords: Regulatory Affairs, IND, CTA, Biotechnology, Cell & Gene Therapy, Regulatory submission pando LI-DNP PandoLogic. Keywords: Operations Specialist, Location: Philadelphia, PA - 19122
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Sr. Regulatory Operations Specialist
1 week ago
Elkins Park, United States Piper Companies Full timePiper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule). Responsibilities for the Sr. Regulatory Operations Specialist · Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders, and develop...
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Sr. Regulatory Specialist
1 week ago
Elkins Park, United States Piper Companies Full timePiper Companies is currently looking for an experienced Sr. Regulatory Specialist (IND Submissions) in Philadelphia, Pennsylvania (PA) to work for an innovative and growing biologic oncology pharmaceutical company. The Sr. Regulatory Specialist will play an integral part in the regulatory IND submission process of new pharmaceutical products....
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Regulatory Operations Associate
3 days ago
Florham Park, United States Planet Pharma Full timeImmediate need for a Regulatory Operations Associate. Prefer someone local to Florham Park, NJ.Looking for the following experience -Publishing, requirements, bookmarks, Use Docubridge publishing tool, understanding lifecycle of documents, partner with RA’s, QCDocubridge experience HIGHLY PREFERREDPublishing eCTD, FDA guidance for submissions3-5 years...
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Regulatory Operations Associate
15 hours ago
Florham Park, United States Planet Pharma Full timeImmediate need for a Regulatory Operations Associate. Prefer someone local to Florham Park, NJ. Looking for the following experience - Publishing, requirements, bookmarks, Use Docubridge publishing tool, understanding lifecycle of documents, partner with RAs, QC Docubridge experience HIGHLY PREFERRED Publishing eCTD, FDA guidance for submissions 3-5 years...
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Menlo Park, California, United States ReCode Therapeutics Full timeWho We Are:ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and...
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RWSHR - Sales & Catering Coordinator
5 days ago
Menlo Park, United States Sales & Catering Coordinator Full timeOVERVIEW/BASIC FUNCTIONResponsible for the coordination and smooth running of all aspects and functions of the Sales & Catering Department in accordance to Rosewood Sand Hill standards. Acts as the lead communication touch point for both internal and external customers. Acts as a support function for both the Director of Sales & Marketing and the Sales...
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Senior Manager, Regulatory Operations
1 week ago
Menlo Park, United States Meet Recruitment Full timeSenior Manager, Regulatory Operations This role, reporting to the Director of Regulatory Operations, entails overseeing the regulatory archives within the Veeva Vault system and internal shared drive. The Manager/Senior Manager will collaborate with a multifaceted team, providing essential support for regulatory filings and projects. Responsibilities...
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Senior Manager, Regulatory Operations
3 weeks ago
Menlo Park, United States Meet Full timeSenior Manager, Regulatory Operations This role, reporting to the Director of Regulatory Operations, entails overseeing the regulatory archives within the Veeva Vault system and internal shared drive. The Manager/Senior Manager will collaborate with a multifaceted team, providing essential support for regulatory filings and projects.Responsibilities...
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Senior Manager, Regulatory Operations
4 weeks ago
Menlo Park, United States Meet Full timeSenior Manager, Regulatory Operations This role, reporting to the Director of Regulatory Operations, entails overseeing the regulatory archives within the Veeva Vault system and internal shared drive. The Manager/Senior Manager will collaborate with a multifaceted team, providing essential support for regulatory filings and projects.Responsibilities...
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Senior Manager, Regulatory Operations
3 weeks ago
Menlo Park, United States Meet Full timeManager or Senior Manager, Regulatory Operations*Hybrid Workstyle - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Manager or Senior Manager of Regulatory Operations to...
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Senior Manager, Regulatory Operations
4 weeks ago
Menlo Park, United States Meet Full timeManager or Senior Manager, Regulatory Operations*Hybrid Workstyle - Menlo Park, CA*Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Manager or Senior Manager of Regulatory Operations to...
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Menlo Park, United States ReCode Therapeutics Full timeWho We Are: ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode's proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and...
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Menlo Park, United States ReCode Therapeutics Full timeWho We Are: ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and...
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Regulatory Operations/Project Management Consultant
13 hours ago
Menlo Park, United States ReCode Therapeutics, Inc Full timeWho We Are: ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and...
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Director of Operations
3 weeks ago
Elkins Park, United States Mai Placement Full timeJob DescriptionJob DescriptionDirector of Operations (Medical Practice) Elkins Park, PA$120k-$150KJob Description:We are looking for a motivated and experienced Director of Operations to oversee the day-to-day management of our medical practice. The ideal candidate will be a self-starter with a strong ability to self-direct and take initiative. This role...
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Director of Regulatory Affairs
2 months ago
Winter Park, Florida, United States Full Sail University Full timeIf you're looking for the chance to learn, grow, and make a contribution to the community, look at employment opportunities with Full Sail University. You'll find your choice of career opportunities, great benefits, an environment that welcomes and values creativity, and a work experience that is both challenging and rewardingThis position will report to the...
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Director of Regulatory Affairs
2 months ago
Winter Park, United States Full Sail University Full timeIf you're looking for the chance to learn, grow, and make a contribution to the community, look at employment opportunities with Full Sail University. You'll find your choice of career opportunities, great benefits, an environment that welcomes and values creativity, and a work experience that is both challenging and rewarding!This position will...
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Regulatory Compliance Specialist
2 days ago
Overland Park, United States Alta Sciences Full timeYour New Company! At Altasciences we allmove in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of...
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Coordinator - Parks and Rec
7 days ago
Elkins Park, United States Cheltenham Township Full timeJob DescriptionJob DescriptionWorking under the direction of the Director of Parks & Recreation, the Recreation Program Coordinator plans, promotes, implements, coordinates and supervises the daily activities of the Cheltenham Township Parks & Recreation Department, including special events, recreation activities, camps, pools, senior activities, classes and...
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Head of Regulatory
4 days ago
Menlo Park, CA, United States Oruka Tx Full timeAbout Us: Oruka Therapeutics is a newly launched company whose mission is to restore skin health. We were founded by well-known investors at Fairmount Funds, in the same model as Apogee Therapeutics and Spyre Therapeutics which together have raised $700M+ over the past two years and have made successful public debuts. We have a lead program that we expect...