Senior Manager, CMC Regulatory Affairs, Global Rare Diseases

Chiesi Usa, Inc.; Cary (NC); Hybrid; USD 121,000 - 182,000; Full time

Benefits offered by this job

Healthcare program

Relocation support

Flexible working arrangements

Remote work options

Job summary

Chiesi Usa, Inc. in Cary, NC seeks a Regulatory Affairs Manager with strong CMC pre- and post-approval experience to support our Global Rare Diseases portfolio.

You will lead regulatory submissions, communicate with agencies, and guide cross-functional teams through lifecycle activities. The role requires a bachelor’s degree in a scientific or technical discipline and 5+ years in Regulatory CMC, with knowledge of ICH and US/EU requirements.

Qualifications

• Bachelor’s degree in a Scientific or Technical field required.
• 5+ years of Regulatory CMC experience.
• Strong knowledge of global CMC regulations (ICH, US/EU).
• Experience authoring CTD M2/M3 and lifecycle mgmt of variations.
• Proficient with TrackWise and regulatory document systems.

Responsibilities

• Maintain or create CMC regulatory documents for a broad range of submissions.
• Collaborate with Core team and GCST with full responsibility and no supervision.
• Represent GRDRA CMC at core team level, globally when required.
• Author/review CMC sections for marketing applications, submissions, variations.
• Advise on regulatory agency requirements for CMC sections in dossiers.
• Review and assess change control requests related to CMC.
• Define regulatory strategy with GRDRA and senior leadership for product lifecycle.
• Track submission information and CMC commitments with minimal supervision.
• Collaborate with CMOs and cross-functional teams on process improvements.

Skills

Regulatory CMC experience

ICH regulations

Documentation

Cross-functional collaboration

Regulatory strategy

Attention to detail

Independent work

Communication skills

Education

Bachelor's degree in a Scientific or Technical Discipline

Advanced degree preferred

Tools

TrackWise

Regulatory DMS

Job description

About Us

Based 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.

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, 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.

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.

Who we are looking for

This is what you will do

Currently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience to support Chiesi’s Global Rare Diseases (GRD) global portfolio of commercial products.

You’ll 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 authorization 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
• 5 + years of Regulatory CMC experience
• 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 system
• 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

We would prefer for you to have

• Advanced Degree in a Scientific or Technical Discipline

Location

Hybrid role based in our Cary, NC office.

Compensation

The annual base pay for this position ranges from $121,000 to $182,000. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If hired, the employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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 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.