Senior Manager, CMC Regulatory Affairs, Global Rare Diseases

Chiesi Group; España; Híbrido; EUR 59.000 - 74.000; Jornada completa

Descripción de la vacante

Chiesi Group is seeking a Senior Manager, CMC Regulatory Affairs, to lead post-approval CMC activities for the Global Rare Diseases portfolio. You will collaborate with GRD RA CMC leadership and cross-functional teams to ensure global submissions.

The role emphasizes regulatory strategy, CMC documentation, and interactions with CMOs across international markets, with a focus on quality and timely delivery.

Formación

• Bachelor’s degree in a scientific or technical discipline; an advanced degree is preferred.
• Minimum of six years of regulatory CMC experience supporting small-molecule, herbal medicinal and/or biological products.
• Demonstrated experience authoring CTD Modules 2 and 3, and managing post-approval changes across international markets ex-US and ex-Europe.
• Experience with quality systems (TrackWise) and regulatory information systems (Veeva RIM) is an asset.

Responsabilidades

• Author and/or review CMC sections for the GRD portfolio and ensure timely global submissions.
• Advise multidisciplinary project teams on regulatory requirements for CMC submissions.
• Collaborate with CMOs to obtain CMC documentation for submissions.
• Develop regulatory strategies for projects in development and for marketed GRD products.
• Prepare timely responses to CMC regulatory questions with cross-functional SMEs.
• Work with CMOs on process optimization, scale-up and technology transfer.
• Review change control requests related to CMC and coordinate filing strategies.
• Maintain submission information in the document management system and track CMC commitments.
• Contribute to SOPs and work instructions for the RA CMC team.
• Represent GRD RA during regulatory GMP inspections when agreed by Lead.

Conocimientos

CMC regulatory

CTD Modules

ICH regulations

Technical documentation

Cross-functional collaboration

Attention to detail

Regulatory strategy

Educación

Bachelor’s degree in science

Advanced degree preferred

Herramientas

TrackWise

Veeva RIM

Descripción del empleo

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

We are seeking a Senior Manager, CMC Regulatory Affairs, with direct experience in post-approval CMC activities to support Chiesi’s Global Rare Diseases (GRD) portfolio of commercial products worldwide.

You will be responsible for

• Author and/or review CMC sections for the assigned GRD portfolio, including new marketing authorization applications, extension applications, investigational applications, post-approval variations and supplements, renewals, and annual reports, ensuring timely, high-quality global submissions
• In alignment with the GRD RA CMC Senior Director and/or Lead, advise multidisciplinary project teams on regulatory agency requirements and expectations for the CMC sections of submission dossiers
• Collaborate with external contract manufacturing organizations (CMOs) and relevant functional teams to obtain the CMC documentation required to support regulatory submissions
• Support the development of regulatory strategies for assigned projects, in alignment with the GRD RA CMC Senior Director and Lead, including both products in development and marketed GRD products
• Prepare timely responses to CMC regulatory questions in coordination with cross-functional teams and subject matter experts (SMEs), as needed
• Work collaboratively with external CMOs and cross-functional teams on process optimization, scale-up, and technology transfer activities
• Review and assess change control requests related to the CMC aspects of GRD products and coordinate the associated filing strategies
• Support the creation and maintenance of CMC submission templates
• Maintain submission information in accordance with the company’s document management system and independently track regulatory CMC commitments and timelines for assigned projects, products, and markets
• Contribute to process development and to the preparation of standard operating procedures and work instructions for the RA CMC team, as needed
• With the agreement of the GRD RA CMC Lead, represent GRD RA during regulatory agency GMP inspections
• Maintain current knowledge of applicable regulations, policies, and guidelines, and remain informed of evolving global CMC regulatory requirements

You will need to have

• Bachelor’s degree in a scientific or technical discipline required; an advanced degree is preferred
• Minimum of six years of regulatory CMC experience supporting small-molecule, herbal medicinal and/or biological products
• Advanced knowledge of current global CMC regulations and guidelines, including ICH requirements and applicable regulatory requirements in the United States, European Union, and Canada
• Demonstrated experience authoring technical documentation and CTD Modules 2 and 3, and managing the lifecycle of quality-related post-approval changes across international markets ex-US and ex-Europe
• Experience with quality management systems, such as TrackWise, and regulatory information and document management platforms, such as Veeva RIM, is considered an asset
• Exceptional attention to detail and a strong commitment to quality and accuracy
• Demonstrated ability to manage competing priorities, maintain strong organization, and consistently meet deadlines
• Excellent written, verbal, and interpersonal communication skills, supported by strong critical-thinking and problem-solving capabilities
• Proven ability to work effectively both independently and collaboratively within a dynamic, fast-paced, and cross-functional environment

Location

The role can be based in any Chiesi affiliates in Europe.

Budgeted Salary Range (package applied for role based in Italy)

The budgeted salary range approved for this role is between €59,040 and €73,800. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position.

Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations.

This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.

In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme.

The package outlined above is based on the role being located in Italy. Where the role is offered in a different Country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process.

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.