Senior Regulatory Affairs Manager

MAH responsibilities

maintain a global oversight with the different entities in the group to ensure MAH responsibilities from a PV / Quality and RA activities standpoint with main focus on pharmaceutical products

ensure oversight of LCM activities and when GSA NL entity is used in development activities for pharmaceuticals (if applicable)

be the point of contact for any regulatory assessment linked to this specific entity of GSA NL Branch

be the point of contact for any Health Authority inspection and ensure the coordination of the preparation and the regulatory requests / sessions

LCM activities for pharmaceuticals

EMA contact point for centralized products

in charge of LCM activities for pharmaceutical products with activities such as maintenance of licenses, coordination with Pharmacovigilance for safety variations, marketing and medical for labelling changes and RA CMC for quality variations

activities include (but not limited to) regulatory strategy, dossier preparation (with regulatory review / input on core documents such as clinical overview), coordination of answer documents in case of HA questions, follow-up of the approval

provide RA input if applicable in PV documents such as PBRER, DSUR and RMP

ensure and update all regulatory databased (Regulatory Information Management System / Electronic Data Management System...)

monitor internal and professional communications concerning relevant regulations (ICH, EMA, ...) and perform regulatory intelligence activities with a focus on European regulation including all the requirements linked to the database and new ways of submitting changes - prepare the gap analysis for the coming new EU pharma law

from the identified changes in the process of this new EU pharm, lead the overall process update within Global Regulatory Affairs (GRA)

perform the impact analysis of transverse regulations such as the Packaging and Packaging Waste Regulation (PPWR) and propose action plans in close collaboration with affiliates

prepare ad-hoc summaries and communication tools to inform relevant stakeholders / management

provides input to maintain and improve processes with regulatory service providers for the activities if applicable

ensures that all regulatory documents are prepared and tracked in EDMS and that all regulatory activities are tracked in the regulatory affairs database

Initiates, reviews and contribute to SOPs, forms, etc. to support regulatory development processes.

contributes to improvements to processes and to ensure continued compliance with applicable regulations

Scientific degree (BSc, MSc, PhD) or Pharmacist qualification

10 years of experience in Regulatory Affairs, including Lifecycle Management activities for centrally authorized products and Health Authority inspections

Experience managing outsourced Regulatory Dossier activities and international projects

Ability to deliver results effectively in a fast-paced environment with tight deadlines

Experience interacting with regulatory agencies and contributing to global regulatory strategies

Strong cross-functional collaboration skills, with the ability to influence and motivate teams

Proven transversal leadership skills

Excellent organizational, planning, analytical, and problem-solving skills

Ability to identify opportunities and critical issues, assess impact, and communicate effectively

Adaptability to changing priorities and dynamic environments

Excellent verbal and written communication skills

Fluent in English and Dutch

What we offer in return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

Our people make a difference

At Galderma, you'll work with people who are like you.

And people that are different.

We value what every member of our team brings.

Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.