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Every career with Hearst Television is like a story. How it develops, where it takes you, the milestones you reach along the way – you’ve got a lot to look forward to as your unique career story unfolds. Hearst Television, a subsidiary of Hearst, owns and operates local television and radio stations serving nearly three dozen U.S. cities, reaching 24 million U.S. television households. Through its partnership with nearly all major networks, Hearst Television distributes national content across more than 120 video channels, including programming from ABC, NBC, CBS, CW, MY Net, MeTV, This TV, Estrella, and more. Hearst Television is recognized as one of the industry's premier companies. It has been honored with numerous awards for distinguished journalism and industry innovation, including the Walter Cronkite Award for political journalism, the national Edward R. Murrow Award, the DuPont-Columbia Award, and the George Foster Peabody Award.

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Manager, CMC Regulatory Affairs, Global Rare Diseases\nDate: 10 Feb 2026

Department: GRD Regulatory Affairs

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: Europe, IT

About us

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Chiesi Global Rare Diseases

Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.

This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.

Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here .

What we are looking for

This is what you will do\nCurrently seeking a Regulatory Affairs (RA) Senior Manager with strong CMC pre and post approval experience to support Chiesi’s Global Rare Diseases (GRD) global portfolio of commercial products

You will be responsible for

Maintain or create CMC regulatory documents for the dedicated product(s) to support a broad range of submissions to Regulatory Authorities, according to the GRDRA strategy

Manage CMC regulatory documents for the dedicated product(s) in close collaboration with the Core team and GCST, with full responsibility and no need of supervision

Act as the GRDRA CMC representative at core team level with a global role, where required

Author and/or review CMC sections of the dedicated GRD portfolio for new marketing authorisation applications, investigational applications and variations/supplements, worldwide

Advise to multidisciplinary project teams on regulatory agency requirements and expectations on CMC sections of submission dossier

Review and assess change control requests pertaining to CMC aspects of GRD product(s)

In alignment with GRDRA CMC functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on the regulatory strategy for the GRD products life cycle and development

Maintain submission information according to the document management system, track regulatory CMC commitments & timelines for specific projects/products/markets with minimal supervision.

Work collaboratively with external CMOs and cross-functional teams on projects like process optimizations, scale up and technology transfer activities.

In agreement with GRDRA CMC functions and collaborating with GRDRA region functions, negotiate with regulatory agencies strategies and actions on CMC sections of submission dossier

Support the development of processes and to the preparation of Standard Operating Procedures where required.

Support due diligence activities on CMC regulatory documents, where required

Represent GRDRA during GMP inspections by regulatory agencies, where required

Maintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements.

You will need to have

Minimum of a bachelor’s degree in a Scientific or Technical Discipline; Advanced Degree strongly preferred.

7 + years of Regulatory CMC experience; 3 + years experience in Biologics/Biopharmaceuticals

(candidates without Biologics experience will not be considered)

Advanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements.

Sound knowledge of manufacturing technical transfer and comparability regulatory requirements

Experience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations.

Proficient in the use of quality management software (e.g. TrackWise) and regulatory document information management syste

We would prefer for you to have

Strong attention to detail.

Ability to multi-task, stay organized and prioritize.

Strong communication skills (oral, written and interpersonal); critical thinking and the ability to identify and recommend solutions to problems.

Ability to work independently and in a group setting and thrive in a fast-paced environment.

Location\nThe position can be based anywhere in Europe with possibility of remote work.

What we offer

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.

DISCOVER ALL OUR JOB OPPORTUNITIES\nScreen readers cannot read the following searchable map.\n#J-18808-Ljbffr\n","Select how often (in days) to receive an alert:

Manager, CMC Regulatory Affairs, Global Rare Diseases\nDate: 10 Feb 2026

Departmen...","Manager, CMC Regulatory Affairs, Global Rare Diseases","Boston, Massachusetts, us, 02298",["B","2583212385"],"Work at Chiesi Farmaceutici S.p.A.","19 hours ago","/jobs/2583212385-manager-cmc-regulatory-affairs-global-rare-diseases","/jobs?keyword=Chiesi+Farmaceutici+S.p.A.","/jobs?location=Boston%2C+Massachusetts%2C+us%2C+02298","/jobs?keyword=Manager%2C+CMC+Regulatory+Affairs%2C+Global+Rare+Diseases",{"_429":428,"_434":527,"_452":453,"_444":514,"_243":528,"_441":529,"_427":428,"_111":530,"_431":194,"_433":194,"_454":453,"_442":531,"_425":532,"_455":520,"_430":115,"_476":533,"_460":534,"_478":530,"_479":531,"_481":523,"_483":535,"_485":536},["D",1770480000000],"Select how often (in days) to receive an alert:\nMedical Affairs Lead, Global Rare Diseases - Contractor

Date: Feb 5, 2026\nDepartment: GRD Global Medical Affairs\nJob Type: Contractor\nBusiness Area: Mktg, Market Access, Bus. Excellence & Med. Affair\nContract Type: Temporary\nLocation: United States, US\nChiesi USA\nBased in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.\nAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.\nDiversity, inclusion, and equal opportunity are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.\nChiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available. This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here.\nWho we are looking for\nThis is what you will do

We are seeking a strategic and collaborative Medical Affairs professional to lead capability development across the global Medical Affairs organization. This 12-month contract role will accelerate the performance of key roles—such as MSLs, Medical Advisors, and Medical Directors—by enhancing both scientific depth and business acumen. You will partner closely with Medical Strategic Operations, HR, L&D, Compliance, and affiliate teams to ensure training initiatives are aligned, impactful, and scalable. This role offers exposure to global medical strategy, rare disease portfolios, and professional development in a dynamic, matrixed environment.\nYou will drive the design, implementation, and continuous improvement of capability-building programs that enable Medical Affairs teams to deliver scientific excellence, patient-focused impact, and operational effectiveness. Working at the intersection of medical strategy, HR, and learning & development, you will ensure that training and development initiatives are targeted, measurable, and aligned with organizational priorities.\nYou will be responsible for:

Needs Assessment & Strategy: Conduct capability assessments across Medical Affairs functions; define global learning priorities aligned with portfolio and organizational goals. Partner with HR to tailor competency frameworks to Medical Affairs’ unique scientific and strategic requirements.\nLearning Design & Delivery: Develop and implement role-based learning journeys for MSLs, Medical Directors, and Scientific Communications team members; lead onboarding, scientific training, compliance education, and soft skill programs (e.g., strategic thinking, communication). Translate learnings into practice through case studies, simulations and field-based applications that reinforce performance-driven behaviors.\nProgram Management: Establish frameworks to track training progress, completion, effectiveness, and impact; ensure scalability across regions and affiliates.\nCross-functional Collaboration: Partner with HR, L&D, Compliance, Legal, and Commercial teams to align content, avoid duplication, and incorporate field insights. Coordinate with HR and Medical leadership to design training that reinforces performance and accountability. Ensure learning initiatives complement broader talent development strategies.\nVendor and Platform Oversight: Manage learning tools and digital platforms to enhance engagement and measure adoption.\nBest Practices & Innovation: Benchmark against industry standards; apply adult learning principles and digital innovation; foster a community of practice for knowledge sharing and continuous improvement. Champion coaching and peer-learning networks that accelerate capability building and a continuous learning culture.\nYou will need to have

5+ years of experience in Medical Affairs, Scientific Training, Learning & Development, or related pharma/biotech roles.\nSolid understanding of the Medical Affairs function, including MSL, Medical Director, Scientific Communication and Medical Information roles.\nExperience designing and delivering adult learning programs in scientific or regulated environments.\nStrong project management and prioritization skills, with the ability to manage multiple initiatives.\nExcellent communication, facilitation, and stakeholder engagement skills.\nFamiliarity with Learning Management Systems (LMS) and digital training tools.\nAbility to work in a matrix organization and lead without direct authority.\nBachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree (PharmD, PhD, MD) or relevant certifications preferred.\nWe would prefer for you to have

Experience in rare disease or specialty therapeutic areas.\nMBA or additional leadership / organizational development training.\nExperience with digital learning, e-learning design, or learning technology platforms.\nKnowledge of Medical Affairs operations, evidence generation, and strategic planning.\nExperience managing global or multi-affiliate teams.\nFamiliarity with regulatory and compliance requirements for training in pharma.\nExperience in change management or capability embedding initiatives.\nTrack record of measuring training impact using KPIs or performance outcomes.\nStrong analytical skills for capability assessment and gap analysis.\nExperience in mid-sized or growing pharma organizations with matrix reporting structures.\nWhat we offer\nNo matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.\nChiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.\nDiscover all our opportunities

#J-18808-Ljbffr\n","Select how often (in days) to receive an alert:\nMedical Affairs Lead, Global Rare Diseases - Contractor

Date: Feb 5, 2026\nDepartment: GRD ...","Medical Affairs Lead, Global Rare Diseases - Contractor","Parma, Ohio, United States",["B","2477344143"],"11 days ago","/jobs/2477344143-medical-affairs-lead-global-rare-diseases-contractor","/jobs?location=Parma%2C+Ohio%2C+United+States","/jobs?keyword=Medical+Affairs+Lead%2C+Global+Rare+Diseases+-+Contractor",{"_429":428,"_434":538,"_452":453,"_444":514,"_243":539,"_441":540,"_427":428,"_111":541,"_431":194,"_433":194,"_454":453,"_442":518,"_425":542,"_455":520,"_430":115,"_476":543,"_460":544,"_478":541,"_479":518,"_481":523,"_483":524,"_485":545},["D",1771174800000],"A leading biopharmaceutical company is seeking a Regulatory Affairs Senior Manager for their Global Rare Diseases unit. The role involves managing CMC regulatory documents and ensuring compliance with global regulations. Candidates should have over 7 years of experience, particularly in Biologics. This position offers opportunities for remote work and the chance to lead projects that make a difference in patients' lives. Benefits include comprehensive healthcare, competitive salary with bonuses, and flexible working arrangements.\n#J-18808-Ljbffr\n","A leading biopharmaceutical company is seeking a Regulatory Affairs Senior Manager for their Global Rare Diseases unit. The role involves managing ...","CMC Regulatory Affairs Manager - Global Rare Diseases",["B","2583202915"],"3 days ago","/jobs/2583202915-cmc-regulatory-affairs-manager-global-rare-diseases","/jobs?keyword=CMC+Regulatory+Affairs+Manager+-+Global+Rare+Diseases",{"_429":428,"_434":547,"_452":453,"_444":548,"_243":438,"_441":438,"_427":428,"_111":549,"_431":432,"_433":194,"_454":453,"_442":443,"_425":550,"_455":551,"_430":118,"_476":552,"_460":553,"_478":549,"_479":443,"_481":554,"_483":484,"_485":555},["D",1771113600000],"SAS","Summer 2026 - Technology Product Marketing Intern",["B","2619543546"],"Work at SAS","4 days ago","/jobs/2619543546-summer-2026-technology-product-marketing-intern","/jobs?keyword=SAS","/jobs?keyword=Summer+2026+-+Technology+Product+Marketing+Intern",{"_429":428,"_434":557,"_452":453,"_444":548,"_243":438,"_441":438,"_427":428,"_111":558,"_431":432,"_433":194,"_454":453,"_442":443,"_425":559,"_455":551,"_430":118,"_476":552,"_460":560,"_478":558,"_479":443,"_481":554,"_483":484,"_485":561},["D",1771113600000],"Summer 2026 - Industry & Vertical Solutions Marketing Intern",["B","2619509224"],"/jobs/2619509224-summer-2026-industry-vertical-solutions-marketing-intern","/jobs?keyword=Summer+2026+-+Industry+%26+Vertical+Solutions+Marketing+Intern","actionData","errors"]