Regulatory Affairs Manager

Job description

The EMEA Regulatory Management Center is a new regional organization to handle the majority of LOC
activities led by senior regional regulatory staff, where they will handle tactical LCM processes (CMC
Variations and Labeling Changes) in the region. The Center has been embedded in the EMEA regional organizations, and will work in close collaboration with the respective LOCs and regional
and global departments.
The RMC is a virtual, dedicated team consisting of GRA regional team members (direct reports) and
LOC team members (matrix organization).
The responsibility of RMC Submission Management is to lead wide range submission processes for
multiple countries, preparing country-specific submission ready dossiers, manage Agency questions
when required and ensure post-approval activities to take place for those submissions.

Principle Responsibilities
· Lead and facilitate LOC CMC variation / label change processes from global dispatch to kick-off of
local implementation following RMC processes
· Prepare submission plan based on global dispatch and country specifics
· Prepare submission-ready dossier based on local regulations and country specific requirements
covered in “recipe book” – in collaboration with LOC staff
· Assess and implement label changes
· Involve EMEA RMC colleagues for specific process steps, eg. for ePackmat, data management
· Enhance related EMEA RMC processes

Required Technical Competencies & Knowledge

Regulatory Strategy
· Good understanding of the pharmaceutical industry and regulatory experience in drug
development and/or marketed products.
· Detailed knowledge of local regulations and guidances in the /cluster/region related to full drug life
cycle. Understanding of how these apply to specific projects and how to interpret them in the
context of the scientific and commercial environment.
· Awareness of the scientific principles (CMC, clinical and non-clinical) applicable to the specific
products.
· Knowledge of quality and supply chain and potential impact to regulatory procedures and status of
products

Drive execution
· Project management: get things done, drive execution, collaborate in virtual teams, task
prioritisation
· Communication skills and cultural sensitivity in working with stakeholders across countries
· Able to communicate in English and have general understanding (incl technical RA English)
· Team player able to effectively collaborate with colleagues in virtual environment and able to do
efficient handovers

Submissions
· Ability to quickly acquire local knowledge and shift between local situations (learning agility)
· Solid RA submission process knowledge; Able to interpret guidances as they apply to submissions
in the countries in scope.
· Knowledge of what is needed for dossier components and submissions, how to obtain regional
components and understanding of timelines. Understanding of documentation requirements.
· Ability to determine whether documents meet regulatory requirements, and are consistent with the
regulatory strategy.

Interactions with Local Operating Companies
· Good understanding of the needs of LOC RA and other RA partners (eg. supply chain, quality).
· Able to interpret and work with local HA requirements
· Able to align with LOC Experts on submission strategy and dossier content

Interactions with global and regional GRA-teams and other Functions
· Good understanding of the needs of global and regional business partners.
· Understanding of compliance requirements and ability to influence outcomes.
· Able to align with global and regional teams (CMC and Labeling CoE; RSMO, RSI and regional
TAs) on submission strategy and dossiers

Desired profile

Qualifications :

·  A minimum of a University degree or equivalent by experience
·  At least 3 years of regulatory experience in the LOC
·  Experience of working in a virtual team and/or global organization would be an asset
·  Previous experience in RA role as Associate, Professional or similar role is of advantage
·  In depth knowledge of local and regional regulations/legislation.
·  Experience in working with limited supervision and able to make independent decisions
·  Excellent verbal and written communication skills – proficiency in written and oral English
·  Cultural sensitivity and ability to work and thrive in a multi-cultural environment.
·  Proactive team player, able to take charge and follow-through.
·  Achievement-oriented with a high degree of flexibility and ability to adapt to a changing
regulatory environment.
·  Proficient use of technology including RA tracking systems (TrackWise /SPS/MPD) - preferred