Regulatory Submissions & RIMS Lead (Hybrid)
$136k - $170kDormont Manufacturing Co
Sarepta Therapeutics is hiring a Senior Manager, Regulatory Operations in Cambridge, MA. This hybrid role involves managing critical RIMS activities to ensure compliance and improve internal processes. You will engage with stakeholders to streamline regulatory submissions and manage timelines effectively. The ideal candidate will have a BA or BS degree, at least 8 years of relevant experience, and expertise with Veeva and document management systems. A competitive salary ranging from $136,000 to $170,000 is offered. #J-18808-Ljbffr Dormont Manufacturing Co
$238k - $374k
...an Executive Director of Global Regulatory Affairs in Boston, MA. This role entails leading a team to oversee the regulatory... ...proven track record in managing submissions and aligning cross-functional teams. The position offers a hybrid work model, competitive salary ranging...Regulatory$150k - $200k
A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug... ...over 7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge,...Regulatory- 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... ...regulatory operations with proficiency in eCTD submissions and vendor oversight. The candidate will... .... The position offers an opportunity to lead cross-functional teams and contribute to...Regulatory
- ...Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative... ...FDA and EMA guidelines, with a proven record of successful submissions. This position promotes a collaborative work environment with...RegulatoryRemote workFlexible hours
- American Family Insurance seeks a Regulatory Reporting & Compliance Specialist in a hybrid role, requiring at least 10 days a month in the office. This position entails ensuring compliance with state regulations and submitting essential filings. The ideal candidate will...RegulatoryWork at office
- Alnylam Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs CMC Development in Cambridge, MA. In this hybrid position, you will be responsible for implementing the global regulatory CMC strategy, shaping regulatory strategies for innovative modalities like oligonucleotide...Regulatory
- A leading pharmaceutical firm is seeking a Senior IT Systems Analyst to oversee technology... ...settings, a strong understanding of regulatory compliance, and the ability to enforce SOPs... ...systems. This position offers a hybrid work schedule and competitive benefits package...Regulatory
$71.1k - $112.5k
Cognizant is seeking a Veeva Vault RIM Test & Validation Lead in Boston, MA. In this hybrid role, you will lead validation activities, ensuring compliance with regulatory standards, and collaboratively work with various stakeholders. The ideal candidate will have hands-...Regulatory- ...proactive and detail-oriented individual who can lead, educate, and inspire our team to achieve... ...strategies to mitigate them. · Ensure Regulatory Compliance: Stay current with EHS... ...available with this position. · This is a hybrid position with 3 days in the office. #J-1...RegulatoryWork at officeLocal areaRelocation
- ...Executive Director of Biostatistics to lead strategic and technical teams across drug... ...excellence in clinical trials and regulatory submissions. The ideal candidate will have extensive... ...regulatory interactions. This position is hybrid-eligible, offering flexibility in the...Regulatory
$148.5k - $214.5k
...preparation and 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...Regulatory$153.6k - $241.34k
A leading pharmaceutical company is seeking an Associate Director to define and lead global regulatory strategies. This role requires significant experience in regulatory affairs and... ...Located in Boston, MA, the position is hybrid and provides a competitive salary range...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
- ...Manager - Investment Compliance in Boston, MA, to lead a team ensuring portfolios meet compliance... ...investment compliance experience, knowledge of regulatory frameworks, and expertise in leading teams effectively. A hybrid work schedule is standard, offering a competitive...Regulatory
- Monte 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 to ensure timely submissions. This role demands expert knowledge in document management...Regulatory
$35 - $45 per hour
Senior Investment Operations Analyst - Boston, MA (Hybrid, Contract) We are currently seeking candidates for an Investment Operations... ...fulfill both internal operational needs and external client or regulatory requests. Build and maintain strong relationships with vendors,...RegulatoryContract workImmediate startRemote work$88k - $145k
Overview As a Lead Vendor Management Advisor (Strategic/Critical Vendors) with American... ...Identify and mitigate supplier risk by ensuring regulatory, security, and policy compliance and... ...unless specified in the posting In this hybrid role, you will be expected to work a...RegulatoryFull timeContract workLocal areaRelocation package- ...legal writing skills. You'll advise clients on electric power regulatory matters and engage in administrative litigation before FERC. This... ...benefits package, including medical coverage, 401(k), and hybrid work opportunities. #J-18808-Ljbffr BCG Attorney SearchRegulatory
$71.1k - $112.5k
Overview As a Veeva Vault RIM Test & Validation Lead (CSV / QEA) , you will make an impact... ...and ensuring compliance of regulatory systems supporting global submissions. You will be a valued member of... ...systems Work model We believe hybrid work is the way forward as we strive...RegulatoryTemporary workWork at office2 days per week3 days per week- ...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
- ...Cambridge, Massachusetts is seeking a Regulatory Affairs Manager to lead the Chemistry, Manufacturing, and... ...skills, and experience with regulatory submissions. The ideal candidate will possess a... ...experience. This position offers a hybrid work model, requiring regular onsite...Regulatory
- ...in Boston, is seeking an experienced Application Security Manager to lead initiatives in security governance and compliance. The role focuses on protecting enterprise applications through regulatory compliance and risk management practices. The ideal candidate will possess...RegulatoryRemote job
$137k - $215.27k
Takeda is seeking a Regulatory Affairs professional in Boston, MA to lead regulatory CMC initiatives for various pharmaceutical... .... You will manage regulatory submissions and foster relationships with... ...authorities. This position is hybrid and offers a competitive salary...Regulatory- ...thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for... ...., with a focus on IND and BLA submissions to the FDA. Experience as a liaison... .... Working Model This role is hybrid. Employees are expected to be...RegulatoryLocal area
$137k - $215.27k
...a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory... ...include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with a salary range of $137,000 to $215,27...Regulatory$148.5k - $214.5k
...critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement of company... .... Proficiency in Vault RIM, Word and Adobe. Skills that... ...#GD-SA #LI-SA #vhd #LI-Hybrid Pursue progress , discover...Regulatory$212k - $333.19k
...Senior Director, Global Regulatory Lead – Oncology At Takeda, we are a forward-looking, world... ...team. Accountable for US FDA submissions and approvals of project(s) of responsibility... ...position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- A leading technology services provider is seeking a Senior AI Security Advisor to join their Boston team. This hybrid role requires over 15 years of cybersecurity experience, focusing on... ...strategize AI initiatives aligning with regulatory standards, ensuring responsible...Regulatory
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