Biologics Regulatory Affairs Manager — Hybrid & Impact
Dormont Manufacturing Co
United Therapeutics seeks a Regulatory Affairs Manager in Durham, NC to lead regulatory activities and ensure timely submissions. You will work closely with various product development teams. The ideal candidate has significant regulatory experience, excellent analytical and problem-solving skills, and must hold a relevant science degree. This is a hybrid position with benefits including health coverage and 401k. #J-18808-Ljbffr Dormont Manufacturing Co
- ...currently an option. Who You Are The Regulatory Affairs Manager, Biologics / Senior Regulatory Affairs Manager,... ...plans, environmental impact assessments, and other submissions in... ...located at our Durham, NC office with a hybrid schedule of 4 days in office and the...SuggestedLocal areaRelocation package1 day per week
- ...mission to develop inhaled drug/biologic and device combination that... ...and is seeking a Senior Manager, Regulatory Affairs who can operate... ...strategy and execution • Direct impact on clinical development and... ...San Mateo, CA and follows a hybrid model with an expectation of...Suggested3 days per week
- ...Regulatory Affairs Manager At Bioventus, our business depends on developing our people. We invest in you and challenge you to... ...current global regulations and standards; assess impact of changes on assigned biologics product lines. Maintain awareness of global regulatory...Suggested
$120.9k - $157.2k
...Experience Financial Assurance and Strategy [CX FAST] Team is a high-impact group that sits at the intersection of finance, sales, and... ..., Sales, CX Delivery, Commercial Finance, and CX Product Management to drive profitable annual recurring revenue (ARR) growth and lead...SuggestedFull timeTemporary workLocal areaFlexible hours- ...Technologies, LLC, based in Raleigh, North Carolina, seeks a Senior Operations Manager to lead daily operations, HR processes, and ensure compliance with government contracts. This hybrid role requires strong project management skills and offers a chance to work across...SuggestedContract work
- ...Responsibilities Lead global regulatory strategy and product... ..., submission, and lifecycle management of regulatory dossiers, including... ...Regulatory Science, Regulatory Affairs, Business Administration,... ...fertilizers, crop inputs, or biological products, with global regulatory...Work at office
- ...is seeking a Program Coordinator II to manage the complaint programs for manufactured... ...entry-level full-time position offers a hybrid work option and involves ensuring compliance... ...and experience in customer service or regulatory compliance. Additional benefits include...Full time
$94k - $189k
Dormont Manufacturing Co is seeking a Regulatory Reporting Accounting Manager Sr. for their Columbus, OH office. This hybrid role focuses on preparing and submitting crucial regulatory filings while ensuring compliance with federal standards. The ideal candidate should...Work at office- ...This role requires a bachelor's degree and 4 years of related experience, along with knowledge of EEO laws and strong investigative skills. The position is hybrid with on-site reporting required in Raleigh, NC. #J-18808-Ljbffr State of North Carolina - Adult Correction
$66.2k - $86.8k
...record review, documentation management, investigation support, and... ...cGMPs, internal procedures, and regulatory requirements. The QA... ...performance in earlier role. Biologics experience preferred. Must... ...partners. Ability to work a hybrid schedule (a minimum of 3 designated...Work experience placementWork at office- ## Manager, Global GMP ComplianceApplyremote type: On-Sitelocations... ...(cGMPs), applicable regulatory requirements, and UTC requirements... ...Facilitate cross-functional impact assessment on UTC product and... ...pharmaceutical, medical device, biologics, OR related regulated industry...Work from home
- ...Business Development Fund – Raleigh, NC (Hybrid Role) – EXEMPT Status Carolina Small... ...research. Nature of Work Underwriting Director manages underwriting staff and key credit... ...knowledge of lending policies, program rules, regulatory guidance, industry trends, and best...Temporary workWork at office
- United Therapeutics is hiring an Associate Director, Financial Planning & Analysis to provide strategic financial guidance. This hybrid role is based in RTP, NC, requiring a minimum of three days per week in the office. The ideal candidate will have significant experience...Work at office3 days per week
$100.8k - $226.79k
...strategic HR initiatives. The role requires a Bachelor's degree and extensive HR experience, especially in leadership. This position is hybrid, based in Raleigh, NC. The ideal candidate will direct operations across key HR functions while ensuring compliance with policies....- Advance Auto Parts in Raleigh, North Carolina, seeks a Manager of Labor Planning & Workforce Management. This hybrid role supports labor forecasting, scheduling, and optimization across multiple locations. Key responsibilities include developing labor forecasts, analyzing...
$97.88k - $213.03k
...seeking a Principal Human Resources Business Partner to strategize and lead HR initiatives that support business objectives. This hybrid role involves consulting with senior leaders, driving talent strategies, and fostering an inclusive workplace culture. Candidates should...Work at officeRemote work$67.12k
...candidate should have a strong background in insurance principles and the ability to mentor junior analysts. The position offers a hybrid work model with routine office presence and is budgeted at a salary of $67,122 annually. Applicants must have a Bachelor's degree in...Work at office$156.8k - $261.3k
McKesson is an impact-driven, Fortune 10 company that... ...) Remote/Onsite/Hybrid: Remote Industry Experience... ...businesses, including Biologics and McKesson owned... ...business planning, ensuring regulatory integrity and... ...business leadership, senior management and governance on...For contractorsRemote work- ...Compliance, Computer, Engineering, Project Management, Validation, and other services. We... ...for the following position: Sr. Regulatory Affairs Manager Summary: The Sr. Regulatory Affairs... ...change controls and regulatory impact assessments. Qualifications Bachelor...
- A leading engineering firm in North Carolina is seeking a Director of Water & Wastewater Master Planning. In this hybrid role, you will develop long-term strategies for sustainable water solutions while leading a high-performing team. This position requires over 10 years...
- Stellar Professionals is seeking an experienced Product Manager in Raleigh, NC to manage the product lifecycle from strategy to delivery. This hybrid role requires strong leadership skills to align technical teams with business objectives. The ideal candidate has proven...
- ...with donors to drive our mission forward. This full-time role will manage a portfolio of 125-150 donors, focusing on personalized... ...communication skills to effectively connect with diverse stakeholders. A hybrid work schedule is available, allowing for flexibility. #J-18808-...Full time
- ...gift fundraising efforts in eastern North Carolina. This role involves building relationships with donors, crafting impactful presentations, and managing a portfolio of major gifts. Ideal candidates will have substantial fundraising experience, excellent communication skills...
$178k - $245k
...oversee analytical method validation, transfers, regulatory filings, and global product launches across biologics/combination drugs. Ensure analytical instrument validation... ...and apply new technologies in GMP environments. Manage projects, timelines, resources, and budgets;...- ...poverty reduction initiatives. The ideal candidate will lead a team, manage CSBG funding allocations, and ensure compliance with federal... ...supervisory roles within economic assistance programs. The role offers hybrid working arrangements. #J-18808-Ljbffr Arts In WilmingtonWork at office
- ...Fund (CSBDF) in Raleigh, NC, seeks an Underwriting Director to manage loan underwriting and analysis functions. The role involves mentoring... ...strong focus on small business and community development. This hybrid position offers competitive salary and benefits, including...
- ...Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to... ..., Head of Regulatory Affairs, will serve as the company’s... ...executive-level guidance to senior management on regulatory risks,... .... Must have experience with biologic products. Proven ability to...Worldwide
- ...someone with 5-7 years of related experience. Responsibilities include managing compliance-related processes, conducting risk assessments, and preparing reports for leadership. The position offers a hybrid work model and embraces diversity, allowing individuals to add to...
$17 - $25 per hour
RegEd, Inc. in Morrisville, NC, is seeking a Licensing Review Analyst to join our innovative team. This hybrid role involves reviewing licensing applications, collaborating with internal teams, and maintaining compliance with regulations. The ideal candidate will possess...Hourly pay- ...company in North Carolina seeks an experienced Senior Director, Head of Regulatory Affairs. This role involves defining global regulatory strategy and overseeing submissions, with a focus on biologic products. Candidates should have over 15 years of regulatory experience...
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