Regulatory Manager CMC, LCM

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

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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 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.

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.
• Life and accident insurance.
• ️ Ticket restaurant
• On-site medical service
• Benefits and Savings Club.
• Training and language learning platform
• ️ Wellness platform with unlimited free psychologist sessions
• Cabify transportation service for employee use
• Development plans, internal mobility policy.
• Many more!

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.