Global Reg-CMC Specialist

Date:  Jul 3, 2024
Department:  Global Regulatory Affairs
Job Type:  Direct Employee
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 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.

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