Regulatory Manager Cmc, Lcm Nib283

Mabxience; Madrid; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Una empresa de biotecnología de renombre busca un Gerente de Regulación CMC y LCM para liderar estrategias regulatorias a nivel global. Esta posición requiere experiencia en el ámbito farmacéutico y proporciona un enfoque estratégico en la gestión de productos a lo largo de su ciclo de vida, trabajando en estrecha colaboración con diversas unidades y autoridades de salud.

Servicios

Horario flexible de lunes a viernes

Contrato permanente

Paquete salarial atractivo

Formación

• Mínimo 3 a 5 años de experiencia en Asuntos Regulatorios en biopharmaceuticals/biosimilars.
• Conocimiento de regulaciones de EMA, FDA e ICH.
• Experiencia en redacción regulatoria.

Responsabilidades

• Definir e implementar estrategias regulatorias globales.
• Preparar y enviar dossiers regulatorios.
• Mantener el cumplimiento normativo durante todo el ciclo de vida del producto.

Conocimientos

Experiencia en regulaciones

Comunicación

Capacidades de resolución de problemas

Toma de decisiones

Educación

Grado en Ciencias de la Vida/Sanidad (e.g., Química, Biología)

Descripción del empleo

Position: Regulatory Manager CMC, LCM

Location: Madrid (on site)

Experience: Minimum of 3 to 5 years’ experience working within Regulatory Affairs in biopharmaceuticals and/or biosimilars, plus additional industry-relevant experience

Want to know more?

The Manager, Regulatory, Chemistry, Manufacturing and Control (CMC), Life Cycle Management (LCM) is responsible for defining and implementing global regulatory roll-out strategies, including regional registration processes and lifecycle management of #mAbxience products. This role provides expert guidance and strategic direction to Commercial Business Units & Operations, Business Development, Legal, Product Development, Clinical, Quality, and Pharmacovigilance teams.



The Manager acts as a primary interface between mAbxience and Health Authorities, as well as partner companies, within assigned local regions.

The Manager, Regulatory CMC LCM is also responsible for providing leadership in the development and execution of global CMC strategies, providing strategic and technical guidance to development teams and ensuring the adequacy of CMC documentation for global regulatory submissions. The position supports and promotes all regulatory CMC tasks throughout the product lifecycle, in collaboration with internal and external stakeholders.

The challenge!

LCM responsibilities

· Responsible for defining and implementing global regulatory strategies, in line with business objectives and in cooperation with regional partner companies and internal/external stakeholders

· Accountable for leading the execution and performance of the following activities:

o Ensuring each product has a defined regulatory strategy and is in compliance with all applicable government regulations and standards set by mAbxience

o Timely submission of regulatory dossiers,



variation packages and local specific regulatory documentation (MAAs, Site Accreditation, etc.) in targeted geographies (EMA, FDA, PMDA, HC) and in close collaboration with partner companies and cross-functional teams

o Preparation of Module 1 in collaboration with the local commercial partner and liaising with internal departments in the compilation and submission of the registration dossier (Modules 2 to 5)

o Drives interactions with partner companies, regulatory authorities, and regulatory units of industry associations in targeted geographies (EMA, FDA, PMDA, HC)

o Lead Health Authority engagement and response strategies for deficiency letters

oMaintaining product compliance throughout the product lifecycle, assessment of post-approval changes and timely closure of post-approval commitments





o Maintenance of regulatory tracking tools and regulatory management database

o Support launch activities

· Strategic business partner for the Regional Commercial Unit

· Support Business Development/Commercial Ops in the review of License agreements and Quality Technical agreements for targeted geographies

CMC responsibilities

· Responsible for writing regulatory CMC sections (focus on analytical methods and their validation) from product development and quality source documents. Accountable for ensuring that all regulatory submissions are scientifically adequate, include an appropriate level of detail and are in compliance with all applicable national and international regulations

· Providing strategic and technical guidance on regulatory CMC topics to product development teams and commercial manufacturing sites (e.g., study protocols,



study reports and technical plans)

· Ensure that regulatory risk(s) identified during product development andor post-approval is mitigated with the appropriate action plan(s) and incorporated into program management planning

· Responsible for the regulatory evaluation of CMC change controls and maintaining product compliance throughout the product lifecycle

· Provide regulatory CMC leadership in product development review boards, project teams, scientific committee meetings and due diligence / commercial licensing activities

Other responsibilities

· Regulatory intelligence:

o Monitor regulatory landscape and provide interpretive analysis and implications on local and regional regulatory guidance documents, regulations or directives on potential impact to mAbxience portfolio and development projects





o Maintenance of regional requirements and submission templates

o Provide training to internal and external stakeholders (as required) on international regulatory requirements

· Responsible for the preparation and maintenance of department SOPs, KPI reporting and facilitating presentations to the mAbxience Executive Committee (MEC)

Accountabilities

KPI related to the job.

· On-time delivery of regulatory submissions and grant of marketing authorization

· Quality of registration submissions, number and size of deficiency letters, number of rejections, etc.

· Regulatory compliance (change control, post-approval activities, etc.)

· Interactions with key business partners and regulatory authorities

· Launch or supply delays due to regulatory (zero delays)

· Meet budgetary obligations

What do you need?

· Education:



Degree in Life/Health Sciences (e.g., Chemistry, Biology, Biochemistry, Pharmacy), or equivalent

· Languages: Fluent English required (oral and written); knowledge of Spanish and other languages will be an asset

· Experience (years/area):

o Minimum of 3 to 5 years’ experience working within Regulatory Affairs in biopharmaceuticals and/or biosimilars, plus additional industry-relevant experience

· Specific Knowledge:

o Knowledge of EMA, FDA, and ICH regulations, guidelines, and pharmaceutical and biologic drug development policies

o Strong understanding of HA expectations and ability to apply knowledge strategically and operationally throughout the product lifecycle

o Experience in regulatory writing (focus on analytical methods and their validation) and reviewing dossier CMC and regulatory documents,



including post-approval variations, responses to HA questions, annual reports, and renewals.

· Travels: 10%

· Personal skills:

o Independent and disciplined decision-making with strong problem-solving capabilities

o Strong interpersonal skills: influencing, diplomacy and tact, empathy and ability to work cross-functionally and in a dynamic, fast-paced work environment

o Strong communication (oral, writing and presentation) and negotiation skills

Our benefits!

- Flexible start time from Monday to Friday (full-time).
- Permanent contract.
- Attractive salary package.
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