Senior Manager Regulatory Affairs
Virtual Vocations Inc
Owning the end-to-end regulatory process, the full-time Senior Manager, Regulatory Affairs will prepare and submit multistate filings, draft model documentation, and support carrier clients in navigating state requirements while working remotely in the USA. Key responsibilities Draft, file, and defend AI and predictive model filings in SERFF, ensuring compliance with regulatory standards Lead objection and interrogatory responses, collaborating with cross-functional teams to address state inquiries Monitor state requirements and provide internal guidance and client updates to support regulatory compliance Required qualifications 6+ years of U.S. P&C insurance industry experience in regulatory affairs or related disciplines Proven experience with multistate P&C rate, rule, and form filings in SERFF Fluency with AI tools and experience in building workflows for regulatory processes Strong technical writing skills with the ability to create persuasive filing narratives Bachelor's degree and legal eligibility to work in the United States
$160k - $170k
...com and follow on social media: @mywoof. \n \n The Opportunity: \n Woof is seeking a strategic, detail-oriented Senior Regulatory Affairs Manager to build and lead regulatory compliance across our growing portfolio of pet products, including consumables,...SeniorWork at officeLocal areaFlexible hours- ...The Role : The Senior Manager, Interconnection & Regulatory Affairs will join the Development Department and support Energix Renewables’ U.S. renewable energy, storage and emerging data center portfolio. The role will manage interconnection strategy and execution across...SeniorFull time
- ...Reference26-00886 Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices... ...will contribute: With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy...Senior
- ...clients seeking world-class professional resources.Job DescriptionUS Regulatory Advertising and Promotion (US Reg AD/Promo) is responsible for... ...according to EEO guidelines.SummaryType: ContractFunction: ManagementExperience level: Mid-Senior LevelIndustry: PharmaceuticalsSeniorFor contractors
- ...Brief team/department description:As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing... ...control assessments.Provide regulatory support for Senior Leadership Team (SLT) and Executive Leadership...SeniorLive in
$175k - $195k
...with other individuals who embody our values: care, be real, get it done, and have fun, seriously.POSITION SUMMARYThe Senior Manager (SM), Regulatory Affairs Labeling will play a key role in providing regulatory expertise and guidance to internal stakeholders for...SeniorLocal areaFlexible hours- The Sr. Manager, Regulatory Affairs is responsible for leading Rauland's global regulatory affairs function and ensuring compliance with applicable domestic and international medical device regulations. This role develops and executes regulatory strategies that support...Senior
- POSITION SUMMARY: Based in Germantown, Maryland Precigen is seeking a highly motivated and experienced Senior Manager/Manager, Regulatory Affairs(level based on candidate experience). This role is responsible for knowledge and application of global regulations governing...SeniorWork at office
- ...are looking forThis is what you will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience to... ...alignment with GRDRA CMC functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on the regulatory...SeniorHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
- ...and implement comprehensive regulatory strategies for new product development, productlife cycle management, and post-market surveillance... ...and mentor junior regulatory affairs professionals, fostering a culture... ...3-5 years in a leadership or senior role.Demonstrated expertise...SeniorFull timeWork at officeRemote work
$132k - $172k
...new paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls...SeniorFull timeTemporary workRemote workWorldwide- ...Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory affairs to lead our growing, dynamic team through global phase 3 clinical trials of a certain product and support other clinical studies. This role includes driving global submission...SeniorFull timeRemote work
$138.7k - $215.1k
The Senior Manager Regulatory Affairs provides senior-level leadership for global regulatory strategy and execution for new, modified, and marketed CONMED medical devices. Directs regulatory submission strategy, agency engagement, labeling and claims review, product lifecycle...SeniorWork experience placementWork at office- ...The Role : The Senior Manager, Interconnection & Regulatory Affairs will join the Development Department and support Energix Renewables’ U.S. renewable energy, storage and emerging data center portfolio. The role will manage interconnection strategy and execution across...SeniorFull time
- ...Senior Manager leading ex-US regulatory strategy for NGS-based in vitro diagnostic products, with focus on EU IVDR and Health Canada approvals. Role... ...obligations Requirements Extensive ex-US regulatory affairs experience, particularly EU IVDR and Health Canada...Senior
$177.3k - $206.85k
...Cytokinetics seeks a Senior Manager in Regulatory Affairs CMC to lead chemistry, manufacturing, and controls regulatory submissions and strategy execution. The role involves coordinating cross-functional teams to prepare high-quality regulatory dossiers and maintain compliance...Senior- ...Stoke Therapeutics seeks a Senior Manager of Regulatory Affairs focused on Chemistry, Manufacturing, and Controls (CMC). This role directs global CMC regulatory strategy, leads lifecycle management, and provides cross-functional guidance for multiple development and commercial...Senior
- ...Senior Manager Regulatory Affairs role responsible for developing and implementing US and Canada regulatory strategy for assigned pharmaceutical products, managing FDA interactions, and ensuring compliance with regulatory requirements throughout the product lifecycle....Senior
- ...Senior Manager Regulatory Affairs position focused on developing and executing US and Canada regulatory strategies for marketed and developmental products. Responsibilities include FDA liaison activities, regulatory submission preparation, and cross-functional coordination...Senior
- ...Senior Manager leading US and Canada regulatory strategy development and implementation for AbbVie's marketed and development-stage products. Serves as FDA... ..., or related field Minimum 6 years regulatory affairs, R&D, or pharmaceutical industry experience At least...Senior
- ...water, while creating long-term value for our customers, communities, employees, and shareholders. Purpose The Senior Manager Rates and Regulatory Affairs is responsible for all regulatory affairs and rates related functions for Liberty's operating entities in Georgia...SeniorLocal areaFlexible hours
$140k - $170k
...nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Sr Manager Regulatory CMC ensures efficient and compliant management of regulatory change control and post-approval activities. Supporting diverse...Senior$135.62k - $203.44k
...Seaport, Boston or Gaithersburg, MarylandReports to: Senior Director, Global Regulatory Strategy About Alexion For over 30 years, Alexion... ...development at every step. Role Overview:The Senior Manager, Regulatory Affairs US lead will be responsible for leading, planning,...SeniorFull timeTemporary workWork at office$160k - $190k
...Job Description Job Description Fate Therapeutics is looking for Senior Manager, Regulatory Affairs CMC to help advance innovative cell therapy products from early development through licensure. In this role, you will shape global CMC regulatory strategy, lead high...SeniorFull time- A small, commercial stage medical device company in the SF Bay area is seeking a Regulatory Affairs Manager or Director to lead a critical 510(k) FDA submission. The company is developing innovative surgical devices to detect gastrointestinal diseases. This role’s primary...Senior
- ...The Senior Manager Process Excellence within Regulatory Affairs is responsible for managing key process excellence and issue management activities that support compliant efficient and inspection-ready Regulatory Affairs operations. This role oversees the Regulatory Affairs...SeniorFull timeWork at officeLocal areaRemote work
$85k - $120k
...Instagram and YouTube. Job Description Opportunity at a Glance Under the general direction of the Senior Director of Regulatory Affairs, the Senior Manager, Regulatory Affairs serves as a regulatory advisor responsible for translating complex regulatory,...SeniorWork at officeFlexible hours$139.8k - $184.8k
...BeOne is seeking an experienced and energetic person to manage, evaluate, and complete regulatory projects consistent with company goals. This individual... ...and tactics. The Manager will represent Regulatory Affairs on cross-functional project teams, will provide input to...SeniorHourly payFull timeLocal area$181k - $213k
...Massachusetts. For more information, visit Position Purpose: The Regulatory CMC Senior Manager is responsible for contributing to the development of... ...Builds and maintains relationships within the Regulatory Affairs department and Technical Operations (CMC) teams Required...SeniorTemporary workRemote work$160k - $170k
Job Summary The Senior Manager, Regulatory Affairs is a senior individual contributor responsible for regulatory decision making and strategy for complex or high-risk products, regions, or regulatory topics. Approves regulatory strategies developed by Managers and below...SeniorPermanent employmentRemote workWorldwide3 days per week
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