Regulatory Affairs Manager: FDA Submissions & Strategy
Integrated Resources
A leading staffing firm is seeking a Regulatory Affairs Manager for a 6-month contract in Wayne, PA. The role involves managing regulatory activities in line with US requirements, ensuring compliance, and coordinating submissions for products. Ideal candidates will have a BA/B.S in a relevant field and significant biopharmaceutical experience, alongside strong communication and organizational skills. #J-18808-Ljbffr
$257k - $314k
...approved by both the FDA and European... ...strengthening our workforce strategy to ensure we have... ...the right way. ~ Manages the day-to-day regulatory activities of assigned... ...planning regulatory submission strategies,... ...Strategic regulatory affairs experience with a proven...SuggestedMinimum wageFull timeLocal areaFlexible hours$208k - $254k
...Director, Regulatory CMC page is loaded## Director, Regulatory... ...approved by both the FDA and European... ...strengthening our workforce strategy to ensure we have the... ..., in the right way.Management of regulatory activities... ...implementation of regulatory submission strategy.* Manage the...SuggestedMinimum wageFull timeLocal areaFlexible hours$160k - $196k
...approved by both the FDA and European... ...strengthening our workforce strategy to ensure we have... ...Associate Director Regulatory Operations Global Submission Mgmt Location: [Conshohocken... ...Global Regulatory Affairs team. In this key... ..., you will lead and manage the planning, compilation...SuggestedMinimum wageFull timeLocal areaRemote workFlexible hours$144.38k - $240.63k
...Manufacturing and Controls (CMC) regulatory strategy for development and... ...to prepare submissions and respond to regulatory... ...may have direct line‑management responsibility.... ...interactions with U.S. FDA or other global regulatory... ...in global regulatory affairs including...SuggestedWork at officeRemote workWorldwide- ...Location: Wayne, PA Job Title: Regulatory Affairs Manager Duration: 6 Months+ Job... ...Function as liaison between FDA and the company for... ...prepare high-quality regulatory submissions for assigned products, including... .... Implement regulatory strategies for the development and maintenance...Suggested
$212k - $259k
...approved by both the FDA and European Commission... ...strengthening our workforce strategy to ensure we have the... ...strategic support and regulatory expertise to drug... ...on the development and submission of labeling components... ...data to department management, internal and external...Full timeLocal areaFlexible hours- ...Sr. Director, Head of Global Labeling Strategy leads the Global Labeling strategy function... ...with key stakeholders in Global Regulatory Affairs and Safety, Clinical Research, Commercial... ...labeling for CSL’s product portfolio. Manages a team of global labeling strategy professionals...Local areaWorldwide
$160k - $196k
...Madrigal, based in Conshohocken, seeks an Associate Director for Regulatory Operations to lead high-quality regulatory submissions and support global initiatives. Ideal candidates should possess a Bachelor’s degree in Life Sciences, with over 8 years of experience in R...Flexible hours$212k - $259k
...Madrigalpharma is seeking a Regulatory Affairs professional in Conshohocken, PA, to provide strategic support for drug labeling. The ideal... ...with global health authorities. Responsibilities include managing FDA labeling documents, ensuring compliance, and leading global...- ...SENIOR MANAGER CORPORATE STRATEGY Posting Start Date: 5/27/26 At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Description: TE Connectivity Overview...Work experience placementWork at officeLocal areaRemote work
$220.5k - $257.25k
...dysfunction. The Director, REMS Strategy & Operations will lead the... ..., ensuring alignment of regulatory requirements with a cohesive... ...and market access strategies. Manage REMS compliance, audit readiness... ...and approval prior to FDA submission. Serve as the operational lead...Full timeWork experience placement- ...Role Overview As Director Strategy & Planning you will be part of a team that is advising our CEO and Executive Council on key enterprise... ...and leading purpose-driven meetings with business leaders. Manage and develop direct reports. Education and Experience:...Live inRemote workFlexible hours
$340k - $415k
...medication approved by both the FDA and European Commission... ...our workforce strategy to ensure we have the right... ...member of the Medical Affairs global team and serves... ...Clinical Development, Regulatory Affairs, Commercial,... ...partnering with MSLs to manage strategic engagements and...Minimum wageFull timeLocal areaFlexible hours3 days per week- ...Therapeutics, Inc. is seeking a Sr. Director, Head of Global Labeling Strategy to lead the Global Labeling strategy function. This leadership role involves managing a global team and ensuring compliance with regulatory standards while developing innovative labeling strategies....
- ...a Director of Commercial Sourcing to oversee global sourcing strategies and supplier relationships. This leadership role involves developing... ...procurement strategies across various CSL entities while managing compliance and risk. Ideal candidates have a strong background...
$182k - $222k
...0 years of biopharmaceutical marketing experience and strong strategic abilities. Responsibilities include leading speaker bureau strategy and collaborating with cross-functional teams. Located in Conshohocken, this hybrid role allows work flexibility with important travel...Work at office$125.36k - $150k
...and seize new opportunities. The Global Incentive Strategy and Performance Senior Manager Role The Global Incentive Strategy and Performance... ...aligning to business objectives, market benchmarks, and regulatory requirements Own the development and governance of...Temporary workLocal areaImmediate startRemote workFlexible hours$90k - $180k
...a Director, Communications Planning to lead the transformation from traditional communications planning to modern, outcome-driven strategy. This isn't just about planning; it's about architecting omnichannel strategies that integrate data, creativity, media, and technology...Flexible hours- ...A leading biotherapeutics company is seeking a Product Manager to support the ANDEMBRY brand. The successful candidate will execute marketing strategies, lead program material development, and manage sales materials. Requires 5-7 years of marketing experience, preferably...
- ...R&D Strategy Director The R&D Strategy team is a dedicated unit within the Office of the Chief Scientific Officer, whose "day-job"... ...the two levels of working with a sense of urgency ~ Ability to manage ambiguity and develop clear, informed strategies from vast and...Work at office
- .../ Director, Clinical Regulatory Affairs Gene Therapy Main... ...help shape regulatory strategy for innovative therapies... ...direct exposure to FDA and global health... ...preparation of regulatory submissions including INDs, CTA/... ..., and lifecycle management activities. ~ Strong...Full timeWork at officeLocal area
- ...Madrigal is seeking a Director of Enterprise Architecture to build and innovate its architecture capabilities, aligning business strategy with technology. You will drive the creation of architecture standards and ensure their operationalization across the organization...
$230k - $270k
...As our new Senior Director, Global Strategy and Program Management , you'll play a key part in this mission... ..., bringing together development, regulatory, medical, commercial, and market access... ...Clinical Development, Medical Affairs, Regulatory, Commercial, Market Access...Work at officeLocal areaFlexible hours3 days per week- Novocure is seeking a Senior Director of Global Strategy and Program Management in Wayne, PA, to lead strategic initiatives across oncology programs. This role involves developing integrated plans and collaborating with cross-functional teams to maximize value for patients...
$232.8k - $271.6k
...Director, Treatment Experience Strategy & Operations Cytokinetics is a specialty cardiovascular... ...that enhance patient access and regulatory requirements with Risk Evaluation and... ...standards, and market access strategies. Manage REMS compliance and audit reporting....Work experience placement- ...iPipeline is seeking a Director of Product Marketing to lead their North American product marketing strategy. This hands-on role involves defining and executing high-impact marketing initiatives, conducting market research, and collaborating with Product, Sales, and Marketing...Flexible hours
- Senior Director, Strategy and Corporate Development Responsibilities and Accountabilities Strategic Project Lead key enterprise‑wide strategic... ...Development and executive leadership. Corporate Development Manage and execute corporate development initiatives, including M&A,...Work at officeLocal area
- ...outcomes-driven care to those who need it most. We offer integrated managed care products, pharmaceutical benefit management and specialty... ...Under the general direction of the Vice President, HEDIS Strategy & Analytics, the Director of Quality Strategy & Acquisition provides...Contract workRemote workFlexible hours
$90k - $95k
A prominent service provider in King of Prussia seeks a Manager for Electronic Payments Strategy and Operations. The role focuses on leading vendor partnerships and optimizing payment processes related to electronic payments. The ideal candidate has a Bachelor's degree...$90k - $95k
Position Summary The Manager, Electronic Payments Strategy and Operations is responsible for leading vendor partnerships, customer experience, operational... ..., and reconciliation. Knowledge of US financial regulatory rules (card network regulations, NACHA rules). Experience...Local area
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