Global Labeling Director - Regulatory Affairs (Hybrid)
EMD Serono
EMD Serono, Inc. is seeking a Director of Global Labeling to provide strategic regulatory expertise for drug labeling. This role involves overseeing the development and approval of labeling documents while ensuring compliance with global standards. Candidates should have over 8 years of pharmaceutical experience and a relevant Bachelor's or Advanced degree. The position offers a hybrid work model, requiring onsite presence 3 days a week in Billerica, MA. A strong track record in regulatory affairs and excellent communication skills are essential for success in this role. #J-18808-Ljbffr
$171.6k - $230.9k
...career advancement across the globe. Position Scope The Director of Global Regulatory Affairs is responsible for defining and executing the global regulatory... ...(e.g., FDA, EMA) to facilitate approvals and label extensions. Provide strategic regulatory input to portfolio...SuggestedFlexible hours3 days per week$248k - $280k
...Position Purpose: The Director, Global Regulatory Strategy will develop and deliver global regulatory strategies to ensure products are developed... ...for assigned activities/programs. Represent Regulatory Affairs in internal teams to align regulatory plans with business...SuggestedTemporary work- ..., Instagram, X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is... ...and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory...SuggestedLocal areaWorldwide
$157.08k - $239.7k
...Location: Burlington, MA (hybrid with 3 days per week... ...are expanding our global presence with... ...Overview The Associate Director, Regulatory, within the Compliance... ...related to promotional and labeling compliance, including... ..., regulatory affairs, or medical review focused...SuggestedFixed term contractWork at officeFlexible hours3 days per week- ...successful operation of Meridian’s quality and regulatory systems. Develop, implement, maintain... ...quality and reliability are met. Ensure global quality regulations, standards and... ...country licensure/registration Product labeling, including unique device identifiers and...SuggestedFixed term contractFlexible hours
$260k - $290k
...life saving treatments Job Description The Head of Global Regulatory Advertising & Promotion will report to the Head of the Global... ...some technical experience in aspects of drug development and labeling Advanced experience with promotional and medical review...Temporary workWork experience placementSummer workWork at office- ...Overview We are seeking a strategic and influential VP, Global Head of Regulatory Affairs to lead global regulatory strategy and execution across a... ...experience Experience with 505(b)(2) and/or EU Hybrid pathways preferred Experience leading major health authority...Full timeLive inWork at officeWork from home
$130k - $150k
...you can feel passionate about. The Associate Director, Marketing, Biologics Testing is responsible for driving the global marketing strategy, positioning, and execution... ...commercial ecosystems in collaboration with Scientific Affairs and regional teams. Integrate data, analytics,...Work at officeLocal areaRemote work- ...industries, our client is seeking a regulatory professional who can thrive... ...the opportunity to influence global regulatory strategy, support... ...detailed reviews of product labeling, clinical and human‑factors... ...of experience in regulatory affairs or quality engineering within...Worldwide
- ...Denttach LLC, a leading medical device manufacturer, is seeking a Regulatory Affairs Specialist in Bedford, MA. This role supports worldwide regulatory compliance and product registrations within a highly regulated industry. Candidates should hold a Bachelor's degree...Worldwide
$105k - $130k
...IT Compliance Analyst Billerica, MA (Hybrid) Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in... ...processes, and controls meet internal policies and external regulatory requirements. This role contributes to maintaining...Work at officeWork from home- ...description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will... ...nonclinical sections of drug product labeling Represent Regulatory Affairs... ...(MS, PharmD, PhD) #LI-Hybrid Physical & Mental Requirements...Live inWork at officeWork from home
- ...candidates for well-validated targets. Reporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent... ...timelines and contribute to development and execution of global regulatory strategies Prepare and review regulatory...Temporary workWork at officeLocal areaImmediate start3 days per week
$179k - $212k
...CSL Seqirus is a global leader in influenza... ...our next Associate Director, Clinical Assay... ...Office. This is a hybrid position and is onsite... ...operational, and regulatory evolution of... ...strategic input for label-enabling immunogenicity... ..., Regulatory Affairs, Statistics, and CMC...Work at officeWorldwide3 days per week- ...Teledyne office locations. ** Job Summary The Director, Customs Compliance – Americas is... ...well as the ability to translate complex regulatory requirements into practical, business‑aligned... ...Own and continuously enhance the global customs compliance program for the Digital...Work at officeRemote work
$207k - $253k
...right way. This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market... ...with Health Authorities on CMC-related topics. Provides global regulatory input and support to quality-related activities, including...Full timeLocal areaFlexible hours- ...Solutions team. This role develops regulatory strategies for existing, new,... ...to ensure compliance globally and acts as an internal champion... ...Reviews and approves product labelling and claims for the US and EU... ...activities for less senior Regulatory Affairs professionals, including but...Work at office
$250k - $310k
...us on X, LinkedIn and Facebook. Role Summary The Executive Director, Regulatory Affairs serves as a visionary leader who shapes long-term program... ...MA. Primary Responsibilities Shape and lead comprehensive global regulatory strategy for a Dyne program, driving long-term...Local area$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime type: Full timeposted on: Posted 3 Days Agojob requisition id: JR\_0... ...with Health Authorities on CMC-related topics.* Provides global regulatory input and support to quality-related activities...Minimum wageFull timeLocal areaFlexible hours$210k - $270k
...Nova Biomedical Corporation What you’ll do Determining effective regulatory pathways for a variety of product types Participate in cross‑... ...1k company match Bonus Program, Generous PTO and paid holidays Hybrid and flexible work arrangements Professional development, engagement...Hourly payWork at officeFlexible hours$207k - $253k
...(MASH). This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations... ...and drive preparation activities for those meetings. Provide global regulatory input and support to quality‑related activities,...Full timeFlexible hours$204k - $245k
...challenge with radical care. The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for... .... This is a full‑time hybrid position (3 days a week) in our... ...experience in CMC regulatory affairs for biologics or gene therapy...Full timeWork at officeFlexible hours3 days per week- ...Regulatory Affairs Specialist (Bedford, MA) Responsibilities Determine and document change assessments for US Class II devices to ensure compliance... ...devices. Team player with ability to work independently in hybrid/in‑person setting (Bedford, MA). Excellent and effective...Worldwide
- ...IT Compliance Analyst Location: Billerica, MA (Hybrid) ROLE SUMMARY The IT Compliance Analyst supports Quanterix’s IT compliance and... ...systems, processes, and controls meet internal policies and external regulatory requirements. This role contributes to maintaining compliance...Work at officeRemote work
- ...Compliance leadership.Assist with compliance requirements for global visitors, demonstrations, and technical exchanges involving foreign... ...to comply with all applicable laws, regulations, rules and regulatory orders. Our reputation for honesty, integrity and high ethics is...Minimum wagePermanent employmentWork experience placementLocal area
$186k - $255.2k
...flexibility. What we need The Director of Compensation will play a key... ...compensation best practices, tools, and regulatory considerations (including FLSA, pay equity, and global frameworks). Comfort navigating... ...is available. We have a hybrid work environment (minimum 3...Work at officeRelocation package3 days per week- ...their people, worksites, and supply chains safe and compliant. As a global leader in contractor and supply chain risk management, our SaaS... ...-functional initiatives are delivered effectively. This role is hybrid, based in Burlington, Massachusetts with three days per week in...Permanent employmentFor contractorsWork at officeImmediate startOverseas3 days per week
- ...The Company is seeking a Chief People Officer to join their executive leadership team and lead the development and execution of a global people strategy. The successful candidate will be responsible for all aspects of HR, including talent acquisition, organizational development...
$135.3k - $202.9k
...Global Regulatory Project Manager We are seeking a Director, Regulatory Project Manager to lead the end-to-end planning and execution of global regulatory submissions... ...experience in drug development and regulatory affairs. Demonstrated ability to lead in a matrixed...Worldwide3 days per week$200k - $240k
...follow us on X, LinkedIn and Facebook. The Director of Compliance provides compliance... ...Compliance helps design and implement a global compliance program to ensure that Dyne... ...works closely with Medical, Commercial, Regulatory Affairs, and G&A colleagues. We seek a strategic...Local areaRemote work
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