Regulatory Manager CMC, LCM

Mabxience group; Madrid; Presencial; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

A leading company in the biopharmaceutical sector is seeking a Regulatory Manager for CMC and LCM to define global regulatory strategies and interact with health authorities. Ideal candidates will have at least 3 to 5 years of Regulatory Affairs experience, focusing on compliance and documentation for biopharmaceuticals and biosimilars, ensuring scientific adequacy and detail in submissions.

Servicios

Flexible start time

Benefits and Savings Club

Training and language learning platform

Wellness platform with unlimited free psychologist sessions

Development plans and internal mobility policy

Formación

• Minimum 3 to 5 years’ experience in Regulatory Affairs in biopharmaceuticals or biosimilars.
• Experience in regulatory writing and compliance.
• Fluent in English and knowledge of Spanish is an asset.

Responsabilidades

• Define and implement global regulatory strategies for products.
• Lead regulatory submissions and ensure compliance with regulations.
• Provide strategic and technical guidance on regulatory topics.

Conocimientos

Regulatory writing

Analytical methods

Problem-solving

Interpersonal skills

Communication

Strategic thinking

Educación

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

Descripción del empleo

Direct message the job poster from mAbxience

Position : Regulatory Manager CMC, LCM

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 and\or 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.
• Interactions with key business partners and regulatory authorities
• 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.

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

• Flexible start time from Monday to Friday (full-time).
• Benefits and Savings Club.
• Training and language learning platform
• Wellness platform with unlimited free psychologist sessions
• Development plans, internal mobility policy.

What will the Selection process be like? ️

Stay tuned to your phone and email! The first thing we will likely do is contact you through one of the two channels.

Prepare well! We will continue with an in-person / virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test.

Wait for the result! We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.

Do you think this offer is not for you?

COMMITMENT TO EQUAL OPPORTUNITIES

Our group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3 / 2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Other

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