Global Reg-CMC Specialist

2 weeks ago


Cary, North Carolina, United States Chiesi USA Full time

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi USA

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.

At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.

What we offer

Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that "Every one of us is different. Every one of us is Chiesi."

Purpose

Pursuing and executing global, robust and innovative Regulatory-CMC strategies, across the entire life-cycle (pre-clinical, clinical, life-cycle and change management) of Chiesi global products and projects, intended as chemically synthetized or biologics DS, DP, medical devices (including the device component of combination products).

* Acting as GRA representative or leader for CMC topics in the project teams to ensure proper planning and communication as well as to support decision-making.

* Writing of Internal Reg CMC WI/SOP, revision or contribution to GRA or Company documents involving Reg CMC.

* Ensuring appropriate analyses and sharing of CMC regulatory external information/intelligence and active participation in commenting for regulatory-CMC related topics.

* Contributing, as active member of the GRA-CMC LCM Unit, to promote collaboration, communication and the continuous growth in terms of efficiency and excellence, ensuring alignment in the execution, proactive sharing of experience and development of proposals for possible new ways of working [within Units of Chiesi REG-CMC (GRA-GRD) and GRA]

* Building and maintaining relationships within and outside GRA, specifically Global Technical Development (GTD), Global Manufacturing Division (GMD), Global Rare Disease Unit (GRD) and Extended Teams.

Main Responsibilities

Within the Global Regulatory Affairs CMC LCM (Life Cycle Management) team, you will:

* be the Regulatory-CMC representative in the global regulatory teams and in the technical teams;

* be accountable and empowered, across the entire drug products life-cycle, for defining the Global Regulatory-CMC strategy and managing Quality regulatory documents (preparing, authoring and leading according to the project plan);

* write full module 3 for NMA (initial application requiring knowledge about and experience in writing development sections writing and understanding, as well as for geographical expansion);

* write quality part for IMPD/IND for Clinical Trials Ph2 and Ph3;

* author fit for purpose regulatory CMC documents from technical reports;

* provide regulatory assessments on Change Controls as well as prepare CMC documents to support the related variations/supplements;

* understand, interpret and advise on regulations, guidelines, procedures, policies, and strategies relating to development, registration and LCM of products, aiming to expedite submissions and approval of CMC applications

Experience Required

Required experience: Indicatively 4-to-6 years experience in Global (EU/US/China) drug Regulatory CMC and/or in CMC Development, with specific knowledge in at least one of the following areas (i.e. regulatory compliance, analytical, manufacturing process etc.). Experience in global regulatory Change assessment (EU/US/China).

Some experience with combination product (inhalation products) and device development is preferable.

Education
  • Bachelor's Degree in Chemistry and Pharmaceutical Technology, Pharmacy, Chemistry, Biology or similar.

Chiesi 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, sexual orientation, marital status, veteran status, gender identity or expression 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.



  • Cary, North Carolina, United States ABB Full time

    Workday Functional Specialist - Data and Testing (HR Transformation Project)Join us at ABB, where our dedicated team is committed to tackling global challenges. Our core values - care, courage, curiosity, and collaboration - along with a strong emphasis on diversity, inclusion, and equal opportunities, drive our mission to empower individuals to develop...

  • Content Specialist

    3 days ago


    Cary, North Carolina, United States Allucent Full time

    At AllucentTM, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Content Specialist to join our A-team (hybrid*/remote). As a Content Specialist at Allucent, you are responsible for supporting...


  • Cary, North Carolina, United States MetLife Full time

    Position Location: 100% Virtual Role Value Proposition: At MetLife, we seek to make a meaningful impact in the lives of our customers and our communities. The Lead LTD Claims Specialist manages a caseload of long term disability insurance claims in accordance with plan provisions and within prescribed time service standards. In this role, the Lead LTD Claims...


  • Cary, North Carolina, United States Abb Holdings Inc Full time

    Quotation Specialist, Residential Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations. Together, we are...


  • Cary, North Carolina, United States SIEMENS AG Full time

    Who we are. Build a brighter future while learning and growing with a Siemens company at the intersection of technology, community and sustainability. Our global team of innovators is always looking to create meaningful solutions to some of the tough Total Rewards, Director, Rewards, Benefits Specialist, Leadership, Compensation, Manufacturing,...


  • Cary, North Carolina, United States Q2 Full time

    As passionate about our people as we are about our mission. What We're All About : Q2 is proud of delivering our mobile banking platform and technology solutions, globally, to more than 22 million end users across our 1,300 financial institutions and fintech clients. At Q2, our mission is simple: Build strong, diverse communities by strengthening...


  • Cary, North Carolina, United States MetLife Full time

    Description and Requirements Role Value Proposition: This role serves as a key member of the Application Protection team. The candidate will be part of a team that maintains responsibility for life cycle management of application Distributed Denial of Service (DDoS), Bot Mitigation, and Web Application Firewall (WAF) application defense capabilities. Life...


  • Cary, North Carolina, United States MetLife Full time

    Description and Requirements Role Value Proposition: This role serves as a key member of the Application Protection team. The candidate will be part of a team that maintains responsibility for life cycle management of application Distributed Denial of Service (DDoS), Bot Mitigation, and Web Application Firewall (WAF) application defense capabilities. Life...


  • Cary, North Carolina, United States Q2 Full time

    As passionate about our people as we are about our mission. What We're All About : Q2 is proud of delivering our mobile banking platform and technology solutions, globally, to more than 22 million end users across our 1,300 financial institutions and fintech clients. At Q2, our mission is simple: Build strong, diverse communities by strengthening their...


  • Cary, North Carolina, United States Q2 Full time

    As passionate about our people as we are about our mission. What We're All About : Q2 is proud of delivering our mobile banking platform and technology solutions, globally, to more than 22 million end users across our 1,300 financial institutions and fintech clients. At Q2, our mission is simple: Build strong, diverse communities by strengthening their...

  • IS Functional Analyst

    2 weeks ago


    Cary, North Carolina, United States Abb Holdings Inc Full time

    IS Functional Analyst - ERP SAP PP/QM/PM Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations. Together,...


  • Cary, North Carolina, United States Black & Veatch Family of Companies Full time

    Together, we own our company, our future, and our shared success. As an employee-owned company, our people are Black & Veatch. We put them at the center of everything we do and empower them to grow, explore new possibilities and use their diverse talents and perspectives to solve humanity's biggest challenges in an ever-evolving world. With over 100 years of...


  • Cary, North Carolina, United States Black & Veatch Family of Companies Full time

    Together, we own our company, our future, and our shared success. As an employee-owned company, our people are Black & Veatch. We put them at the center of everything we do and empower them to grow, explore new possibilities and use their diverse talents and perspectives to solve humanity's biggest challenges in an ever-evolving world. With over 100 years of...

  • IS Functional Analyst

    2 weeks ago


    Cary, North Carolina, United States Abb Holdings Inc Full time

    IS Functional Analyst - ERP SAP PP/QM/PM Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations. Together,...


  • Cary, North Carolina, United States Siemens Corporation Full time

    Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally...

  • CS Project Controller

    2 weeks ago


    Cary, North Carolina, United States Siemens Corporation Full time

    Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique...


  • Cary, North Carolina, United States Apple Full time

    Join a dynamic team of HR professionals in the Apple People Services and Technology organization, focused on providing outstanding employee service using enterprise technology solutions. The People Product Management (PPM) team, a group with People Services and Technology, is looking for an experienced ServiceNow HRSD Product Manager to partner with our...

  • Central Wake County

    2 weeks ago


    Cary, North Carolina, United States Wake County Public Schools Full time

    POSITION TITLE (Oracle title)SOCIAL WORKER WORKING TITLESocial Worker SCHOOL/DEPARTMENTCounseling and Student Services (CaSS) LOCATIONCrossroads II, Cary, NC PAY GRADEGuidance Counselors/Social Worker Salary Scale FLSA STATUSExempt ELIGIBILITY FOR EMPLOYMENT CONTRACTNo WORK WEEK SCHEDULEMonday-Friday (occasional evenings and weekends) POSITION...


  • Cary, United States Chiesi USA Full time

    About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group research,...


  • Cary, United States Chiesi Farmaceutici S.p.A. Full time

    Select how often (in days) to receive an alert: Team: R&D, Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Cary, NC, US About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi...


  • Cary, United States Amerit Consulting Full time

    OVERVIEW:Our client, a Global Fortune 50 organization and one of world’s largest distributors of Health care systems, medical supplies & Pharmaceutical products, seeks an accomplished Reimbursement Specialist.IMPORTANT HYBRID/ Work-From-Home related:THIS WILL BE A HYBRID ROLE.Location: 11800 Weston Parkway, Cary, NC 27513Duration: 5 months assignment with...


  • Cary, United States Amerit Consulting Full time

    OVERVIEW:Our client, a Global Fortune 50 organization and one of world’s largest distributors of Health care systems, medical supplies & Pharmaceutical products, seeks an accomplished Reimbursement Specialist.IMPORTANT HYBRID/ Work-From-Home related:THIS WILL BE A HYBRID ROLE.Location: 11800 Weston Parkway, Cary, NC 27513Duration: 5 months assignment with...


  • Cary, United States PSG Global Solutions Full time

    Description We're looking for a Mobile C-Arm Clinical Applications Specialist , working in Healthcare Systems and Services industry in Cary, North Carolina, United States . Demonstrate products during customer visits and at workshops to provide sales support. Ensure that the Clinical Education training on mobile C-arm systems and components is facilitated to...


  • Cary, United States BetaNXT Inc Full time

    Job DescriptionJob DescriptionMediant, a BetaNXT company, provides investor communications technology and technology-enabled solutions to banks, brokers, corporations, funds and investment managers.  Mediant’s innovative technology ensures regulatory compliance and creates opportunities to strengthen shareholder and client engagement.    Customer...

  • Content Specialist

    3 days ago


    Cary, United States Allucent Full time

    At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Content Specialist to join our A-team (hybrid*/remote). As a Content Specialist at Allucent, you are responsible for...

  • VP of R&D

    1 month ago


    Cary, United States a Pharmaceutical company based in TX Full time

    RESPONSIBILITIESDeveloping innovative scientific and production strategies to support business expansion and explore new opportunities.Overseeing the development of chemical synthesis pathways or other methods for producing compounds of interest, aligned with our business strategy.Providing strategic leadership to develop and implement a comprehensive...


  • Cary, United States Pentair Full time

    Job Description: At Pentair, you will work along-side passionate problem-solvers who are committed to the future of our planet. We put our purpose into practice, inspiring people to move, improve and enjoy life's essential resources for happier, healthier lives. From our residential and business water solutions to our sustainable innovations and...


  • Cary, United States Pentair Full time

    Job Description: At Pentair, you will work along-side passionate problem-solvers who are committed to the future of our planet. We put our purpose into practice, inspiring people to move, improve and enjoy life's essential resources for happier, healthier lives. From our residential and business water solutions to our sustainable innovations and...


  • Cary, United States Pentair Full time

    Job Description: At Pentair, you will work along-side passionate problem-solvers who are committed to the future of our planet. We put our purpose into practice, inspiring people to move, improve and enjoy life's essential resources for happier, healthier lives. From our residential and business water solutions to our sustainable innovations and...


  • Cary, United States PSG Global Solutions Careers Full time

    Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Mobile C-Arm Clinical Applications Specialist, working in Healthcare Systems and Services industry in Cary, North Carolina, United States. Demonstrate products during customer visits and at workshops to provide sales...


  • Cary, United States MetLife Full time

    Position Location: 100% Virtual Role Value Proposition: At MetLife, we seek to make a meaningful impact in the lives of our customers and our communities. The Lead LTD Claims Specialist manages a caseload of long term disability insurance claims in accordance with plan provisions and within prescribed time service standards. In this role, the Lead LTD Claims...


  • Cary, United States EAG-LED Global Lights Full time

    Job DescriptionJob DescriptionLED SpecialistSales representative with ZERO sellingEAG-LED GlobalThe world’s largest and most popular, woman owned LED manufacturer.Are you a professional, driven, self-starter who loves the idea of an unlimited income potential without having to be a pushy salesperson?Work with one of America’s Premier LED manufacturers to...


  • Cary, United States EAG-LED Global Lights Full time

    Job DescriptionJob DescriptionLED SpecialistSales representative with ZERO sellingEAG-LED GlobalThe world’s largest and most popular, woman owned LED manufacturer.Are you a professional, driven, self-starter who loves the idea of an unlimited income potential without having to be a pushy salesperson?Work with one of America’s Premier LED manufacturers to...


  • Cary, Illinois, United States Stryker Full time

    Why RA/QA at Stryker?Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities If you are interested in working at...


  • Cary, United States Riverbed Technology Full time

    Riverbed. Empower the Experience Riverbed, the leader in AI observability, helps organizations optimize their user’s experiences by leveraging AI automation for the prevention, identification, and resolution of IT issues. With over 20 years of experience in data collection and AI and machine learning, Riverbed’s open and AI-powered...


  • Cary, United States Stryker Full time

    Work Flexibility: Hybrid Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around...


  • Cary, United States Trilliant Full time

    Trilliant offers a universal communications platform that is at the convergence of the smart grid, smart city, and global Industrial Internet of Things (IIoT) applications. We bring together multi-technology solutions, global capabilities, and mission-critical communications to deliver future-proof solutions.We are a device-agnostic, integrated,...


  • Cary, United States Trilliant Full time

    Trilliant offers a universal communications platform that is at the convergence of the smart grid, smart city, and global Industrial Internet of Things (IIoT) applications. We bring together multi-technology solutions, global capabilities, and mission-critical communications to deliver future-proof solutions.We are a device-agnostic, integrated,...