Details of competences and experiences

My main competences are based out of the Regulatory Affairs World. Over the last 20 years the knowledge and experience gained up mainly in European RA, but also regions like CIS, SEA, LatAM and MENA were part of my responsibility . Working with on site and virtual teams and colleagues was part of the daily business.

Beside Regulatory Affairs, Quality Assurance and Pharmacovigilance tasks drove my career. Especially, over the last years the cross-functional knowledge increased significantly.

Based on my broad experience, I can offer individual consultancy in each field or in combination. Developing, adapting and implementing of processes, as stand-alone or in a cross-functional way, are part of my knowledge portfolio, as well as re-structuring of teams in a change process.

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Areas of competences

Regulatory Affairs

Dossier due diligence
Dossier compilation
Scientific advice meetings
Network with regulatory bodies
RIMS & DMS
xEVMPD & IDMP
MDR & IVDR
Regulatory Compliance Management System

Leadership

Leading of virtual & local teams with different cultural background
Leading teams up to 50 people across multiple countries
Re-fitting team structures according company / business vision and needs
Ability to define strengths of the team members and strengthen them.
Ability to define the missing areas of experience and fill it with complementary new team members

Project - & Changemanagement

Gap analysis of processes
Systematic development of process steps
Implementation of RA processes into the management process
Improvement of time management and efficient daily business work
Definition of KPIs and implementation of required tools to measure them
Re-structuring of the team(s) to create ability to fulfill business requirements

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Main milestones in my career

Regulatory Affairs

Starting in Regulatory Affairs in compiling the non-clinical module (2002)
Entering the pharmaceutical generic industry (2006)
Filing of the first multi-country & multi-procedural DCP (2008)
First Scientific advice meetings with local European Authorities (2012)
Multi-country expansions e.g. MENA, SEA, EU, LatAM (2013)

First Scientific advice & pre-submisson meeting with EMA (2017 & 2018)

First CP filing (2019)
Deep dive into MDR & IVDR (2021)
Implementation of a Regulatory Compliance Management System (2021)

Leadership

Taking over the first team lead for New Application (2010)
Leading the German RA Team (2011)
Optimization of recruiting process for increasing team size (2013)
Leading a local team of 40 RA managers in German HQ and 15 RA managers in real & virtual teams (2013)
Founding, implementing and training of a maintenance team in the Indian HQ for improving the integration process and efficacy of maintenance processes (2016)
Build-up of cross-functional teams from the ground and define processes and responsibilities (2020)

Projects

Build-up of new team-structure according the business needs (2013)
Create processes and KPIs for measuring efficiency (2013)
Global portfolio expansion oriented on business requirements (2013)
Restructure teams from everyone is doing everything to specific Areas of Responsibilities (2014)
Strengthen the identified strengths of individuals and design the team (2016)
Review and optimse processes in the given environment (2017)
Lead cross-functional virtual teams for implementation of RIMS
Increase efficiency based on process improvement and defined KPIs (2017-2020)

Individual positions and roles over the last 10 years essential for developing experience in RA/RC skills, knowledge and leadership

Today

Head of Global Regulatory Affairs

Recipharm, Wasserburg

07.21 - 09.22

Head of Regulatory Compliance

Sartorius Stedim Biotech GmbH, Göttingen

04.21 - 07.21

(Interim) Head of Regulatory Affairs
PUREN Pharma GmbH & Co. KG/ Aurobindo Pharma Limited, München

02.20 – 03.21

Managing Director QA, PV & RA

Aurobindo Pharma GmbH, München

05.14 – 01.20

Head of Regulatory Affairs Europe Generics (prokura) at betapharm Arzneimittel GmbH
Dr. Reddy’s Laboratories, Augsburg

11.12 – 04.14

Head of Global Regulatory Affairs at WÖRWAG Pharma GmbH & Co. KG, Böblingen

11.11 – 10.12

Head of Regulatory Affairs at betapharm Arzneimittel GmbH/ Dr. Reddy’s Laboratories, Augsburg

Main Activities:
• Lead a team of +30 people in multiple countries and different product areas

• Develop the decentralised Regulatory Team to one global organisation

• Provide guidance for Regulatory Affairs topics in new developments and maintenance

• Lead activities of Regulatory Affairs globally and ensure the integration of RA services in the value chain of the company
• Develop and implement the global regulatory strategies for new businesses and new markets
• Ensure global regulatory surveillance including deployment of regulatory intelligence and the implementation of necessary tools.

• Identify an optimal regulatory & compliance strategy for new product development projects
• Interface with (global) regulatory authorities, external consultants

Main Activities:

• Develop the Regulatory Compliance Management System with process integration

• Lead activities of Regulatory Compliance globally and ensure the integration of M&A sales into the Q&RCMS

• Develop and implement the global regulatory strategies for new businesses and new markets

• Ensure global regulatory surveillance including deployment of regulatory intelligence. Anticipate regulatory changes, define and lead integration projects.

• Identify an optimal regulatory & compliance strategy for new product development projects

• Interface with (global) regulatory authorities and outside consultants and supervise

• Lead a team of +20 people in all areas of RA and Regulatory compliance activities and provide guidance.

Main Activities:

Lead a team of 10 people in all areas of RA activities
Coordinate local RA activities in relation to multiple countries needs
Implement KPIs for departmental and individual performance
Give advice and support all groups in decision making process.
Review and improve internal processes.

Main Activities:

Lead a team of 14 people in the areas of PV, QA and RA.
Give advice and support all functions in decision making process.
Review and improve internal processes.
Being interface between technical and commercial aspects to allow growth.

Main Activities:

Lead a team of 20 people across EU in all areas of RA activities
Coordinate European RA activities across multiple countries, incl. India
Implement KPIs for departmental and individual performance
Give advice and support all groups in decision making process.
Review and improve internal processes.
Being interface between technical and commercial aspects to allow growth.

Main Activities:

Lead a team up to 40 people in all areas of RA activities, incl. artworks
Coordinate Global RA activities across multiple countries, incl. Russia
Support business to enter new non-EU markets, e.g. MENA, LATAM
Implement KPIs for departmental and individual performance
Re-structure the global RA systems for performance improvement
Give advice and support all groups in decision making process.
Set, review and improve internal and cross-functional processes.
Being interface between technical and commercial aspects to allow growth.

Main Activities:

Lead a team of 10 local RA managers in all areas of RA activities
Support European RA activities
Follow up of EU goals KPIs individual performance
Give advice and support each RA manager in any relevant RA aspects
Review and improve internal processes.
Being interface between technical teams in betapharm