Senior Regulatory Submissions Lead
Digitas Health
Digitas Health is seeking a Senior Associate for Regulatory Promotional Operations to manage complex submission deliverables for pharmaceutical clients. The ideal candidate has a Bachelor's degree and 2-4 years of experience in the industry, along with strong skills in Adobe Acrobat and Microsoft Office. Responsibilities include assembling submission packages, managing project timelines, and maintaining departmental archives. Competitive compensation and a supportive benefits package are offered. #J-18808-Ljbffr Digitas Health
- ...Praxis Precision Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory submissions to U.S. and international agencies. The role requires at least 7 years of experience in the pharmaceutical or biotech industry and strong management...SeniorRegulatoryRemote work
- ...years of relevant experience. The successful candidate will lead complex projects, collaborate with clients, and ensure high-... ...statistical analysis for clinical research, product development, and regulatory submissions. Strong knowledge of drug development processes and ISO...SeniorRegulatory
$130k - $150k
...seeking a Medical Writer to support clinical development programs. The candidate will be responsible for producing high-quality regulatory documents and collaborating with cross-functional teams to ensure compliance. Requirements include a Bachelor's degree, 4+ years...SeniorRegulatoryRemote work$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...SeniorRegulatoryRemote work- ...A leading biotechnology company is seeking a Regulatory Writing Senior Manager to lead writing activities for product submissions. This role involves authoring and overseeing regulatory documents, providing expertise, and mentoring junior writers. The ideal candidate will...SeniorRegulatoryRemote workFlexible hours
- ...biotechnology company in New York seeks a Senior Regulatory Affairs Manager. This role involves... ...include defining regulatory pathways, leading FDA filings, and ensuring integration... ...regulation and a proven ability to manage submissions efficiently. The position offers...SeniorRegulatory
- A pioneering life sciences company in New York is seeking a Senior Regulatory Affairs Manager to shape its regulatory strategy across a diverse... .... This leadership role will manage FDA and global submissions, ensuring the integration between regulatory, R&D, and commercial...SeniorRegulatory
$72k - $90k
A healthcare organization in Bronx, New York is seeking a Senior Regulatory Consultant to oversee management of cancer clinical trials. The role involves ensuring compliance during trial submissions, mentoring junior staff, and developing clinical protocols. Candidates...SeniorRegulatory- A leading cancer treatment center in New York is seeking a Senior Regulatory Compliance Coordinator to oversee clinical trials and ensure compliance with regulatory... ...closely with investigators, manage regulatory submissions, and mentor junior staff. A Bachelor’s degree...SeniorRegulatory
- ...A global clinical research organization is seeking a highly organized Senior Regulatory Affairs Associate to coordinate regulatory submissions across regions. The successful candidate will manage submission activities, ensuring timely and compliant filings that support...SeniorRegulatory
- A leading regulatory consultancy located in New Jersey is seeking an experienced Regulatory Affairs specialist. The role involves supporting US and EU regulatory submissions while ensuring adherence to regulations concerning medical devices. The ideal candidate should have...SeniorRegulatoryWork at office
$140.4k - $210.6k
A leading biopharmaceutical company is seeking experienced professionals for a Statistical Programming role in New Jersey. This... ...various projects, ensuring deliverables support oncology regulatory submissions. Candidates need a Master's degree in Biostatistics and at...SeniorRegulatory- ...Gan & Lee Pharmaceuticals is seeking a Regulatory Affairs professional to support the implementation of regulatory strategies. Responsibilities include ensuring compliance for product submissions and regulatory interactions. The ideal candidate will have a Bachelor of...Regulatory
- ...highly skilled and self-motivated Senior SAS Programmer with extensive lead and co-lead experience, particularly... ..., ensuring compliance with regulatory standards and guidelines. - Independent... ...committees and boards. - Submission Activities: Participate in submission...SeniorRegulatoryContract workInterim roleRemote workWork from home
- ...clinical-stage rare disease company is seeking a Director/Senior Director of Regulatory Affairs. In this strategic role, you will manage global regulatory strategies for submissions in the US, EU, UK, and Japan. You will lead major submissions, engage with regulatory agencies...Regulatory
- ...Apr is seeking a Contract Senior Manager, Regulatory Affairs, to oversee the submission of regulatory documents to National Health Authorities. This role requires a minimum of 5 years of regulatory affairs experience in the pharmaceutical or biotechnology sector. The successful...RegulatoryContract work
$128.6k - $210k
Regeneron Pharmaceuticals, Inc is seeking a Senior Clinical Pharmacologist to lead the planning and analysis of pharmacokinetic studies. The ideal... ...and collaboration across various teams to support regulatory submissions. The position offers a competitive salary range of $...SeniorRegulatory- ...Senior FM Certification Lead – SAF/FM Workforce Development & Executive Support Position Summary The... ...Competency (C2C) mapping and alignment submissions to OUSD(C). Provide executive-level... ...stakeholders. Knowledge & Regulatory Familiarity DoDI 1300.26 – DoD Financial...SeniorRegulatory
- ...seeking a highly organized and detail-oriented Senior Regulatory Affairs Associate to serve as a Regional Submission Coordinator . This is a key operational role responsible... ...strategy as defined by the Regional Regulatory Lead (RRL) and submission team Coordinate closely...SeniorRegulatoryWork at officeLocal area
- ...A leading biopharmaceutical company is looking for a Senior Medical Writer to develop clinical documents for regulatory submissions. The candidate will manage medical writing projects, lead timelines, and collaborate with cross-functional teams. Key qualifications include...SeniorRegulatoryRemote work
$128k - $176k
...A leading biotech company is looking for a Senior Medical Writer to provide support for developing complex clinical and regulatory documents. The ideal candidate will have a degree in a scientific... ...managing content for regulatory submissions and ensuring quality standards...SeniorRegulatoryRemote work- ...A leading life sciences company is seeking a Regulatory Operations Manager to oversee the publishing of deliverables for electronic submissions to health authorities. The role involves vendor oversight, quality control of submission-related documents, and ensuring compliance...RegulatoryRemote work
- Sanofi is seeking a Global Regulatory Affairs (GRA) Chemistry, Manufacturing and Controls (CMC) Lead to drive regulatory strategy for pharmaceutical products and vaccines... ...CMC strategies, managing regulatory submissions, and collaborating across various teams. The ideal...RegulatoryFull time
- ...is looking to hire a talented Senior Document Control Specialist / Document Control Lead for a major project at LGA. Position... ...quality checks on document submissions for compliance with standards... ...FAA, NEPA, or aviation‑related regulatory documentation (a plus) #J-1880...SeniorRegulatoryWork at office
- A biopharmaceutical company is seeking a Senior Manager, Global Regulatory Affairs Labeling to lead its global labeling initiatives. This role involves strategy development for labeling, ensuring compliance, and managing cross-functional stakeholder reviews. Candidates...SeniorRegulatoryRemote work
$2,000 - $4,500 per month
...A growing med-spa organization is seeking a Senior Legal Compliance and Licensing Specialist to lead compliance across multiple U.S. locations. This role demands... ...a professional with over 5 years of experience in regulatory compliance within the med-spa or healthcare sector...SeniorRegulatoryRemote work- ...storage assets. Ideal candidates should have 6-10+ years of NERC compliance experience in grid infrastructure and a strong grasp of regulatory standards. The position offers an attractive compensation package, including flexible work hours, health benefits, and...SeniorRegulatoryRemote workFlexible hours
- ...Framework Ventures is seeking an experienced Compliance Manager to oversee AML and regulatory compliance in Hong Kong/Singapore. This role involves shaping compliance infrastructure, managing regulatory relationships, and ensuring adherence to compliance programs across...SeniorRegulatory
- ...A leading financial services firm is seeking a Senior Compliance Manager to oversee compliance initiatives and manage regulatory reporting requirements. The ideal candidate has 7-10+ years of experience in compliance within the financial services industry, particularly...SeniorRegulatoryRemote work
$186.49k - $278.88k
...Otsuka Pharmaceutical Co., Ltd is seeking a skilled individual to lead labeling strategy and development for their products in the... ...experience in pharmaceutical labeling, a strong understanding of regulatory affairs, and excellent communication skills. A competitive...SeniorRegulatory
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