Maria Berlenbach - GMP Boot Camps Participant

Q: Where is Maria based?

Maria is based in Mainz, Germany .

Q: What languages does Maria speak?

Maria speaks the following languages: Spanish (Native), German (Advanced), English (Advanced) .

Q: How many years of experience does Maria have?

Maria has at least 27 years of experience. During this time, Maria has worked in at least 10 different roles and for 10 different companies . The average length of individual experience is 3 years and 8 months . Note that Maria may not have shared all experience and actually has more experience.

Q: What is Maria's latest experience?

Maria's most recent position is Senior Specialist, Global Regulatory Affairs (CMC Site-to-Site Transfer) at MSD Animal Health GmbH .

Q: What companies has Maria worked for in recent years?

In recent years, Maria has worked for MSD Animal Health GmbH , Hennig Arzneimittel GmbH , Boehringer Ingelheim (via Brunel temporary agency) , and Sanofi Aventis Frankfurt Höchst .

Q: Which industries is Maria most experienced in?

Maria is most experienced in industries like Pharmaceutical , Cosmetics , and Chemical . Maria also has some experience in Healthcare .

Q: Which business areas is Maria most experienced in?

Maria is most experienced in business areas like Quality Assurance , Research and Development , and Product Development .

Q: Which industries has Maria worked in recently?

Maria has recently worked in industries like Pharmaceutical .

Q: Which business areas has Maria worked in recently?

Maria has recently worked in business areas like Quality Assurance and Product Development .

Recommended expert

Mainz, Germany

Experience

May 2024 - May 2026

2 years 1 month

Senior Specialist, Global Regulatory Affairs (CMC Site-to-Site Transfer)

MSD Animal Health GmbH

Conducted regulatory dossier evaluations and GAP assessments for site-to-site transfers.
Implemented eCTD format in Veeva Vault for electronic submission management.
Managed finished product and packaging site transfer submissions across multiple markets.
Prepared scientific responses to regulatory authority queries and ensured timely change notices.
Applied strategic thinking to resolve technical and regulatory issues.
Demonstrated initiative, independent thinking, anticipatory foresight, and effective communication with stakeholders.

Jun 2023 - Nov 2023

6 months

Regulatory Affairs CMC Manager

Hennig Arzneimittel GmbH

Collaborated with regulatory authorities in Korea and GCC countries to prepare and submit CMC documentation.
Utilized scientific expertise to optimize product dossiers and improve approval chances.
Built relationships with regulatory agencies and pharmaceutical companies to facilitate information exchange.
Introduced all company product CMC dossiers into the docuBridge database for electronic submission management.
Managed compiling, publishing, importing, and reviewing regulatory content.

Apr 2022 - Nov 2022

8 months

Quality Manager – Complaints

Boehringer Ingelheim (via Brunel temporary agency)

Managed the investigation and closure of quality complaints and adverse events in collaboration with pharmacovigilance and quality departments.
Contributed to continuous process improvement and compliance initiatives while maintaining regulatory documentation standards.
Applied conceptual and constructive approaches to problem solving to ensure timely resolution of issues.

Sep 2020 - Nov 2021

1 year 3 months

Quality Manager Review (Maternity Leave Replacement)

Sanofi Aventis Frankfurt Höchst

Reviewed quality-relevant and company-specific documents, including CMC dossiers, batch master records, SOPs, logbooks, and batch production records (BPR).
Collaborated with interdisciplinary teams from production, engineering, quality, and contractors during product transfers from clinical trials to commercial manufacturing.
Assessed and tracked out-of-specification (OOS) and out-of-trend (OOT) events to support quality compliance initiatives.
Ensured adherence to internal and regulatory standards under high workload and tight deadlines.

Oct 2019 - Mar 2020

6 months

QA/QC Officer

CSM / Clinigen Group

Served as QA/QC officer until contract termination due to COVID-19 pandemic lockdown.

Sep 2018 - Aug 2019

1 year

Regulatory Affairs Specialist (Maternity Leave Replacement)

Abbott GmbH

Developed, implemented, and maintained regulatory labeling, stickers, and master files for products and reagents across 69 countries.
Coordinated global regulatory content management to ensure compliance with local and international regulations.
Provided regulatory support for product documentation to facilitate smooth approvals and lifecycle management.

May 2014 - Jun 2018

4 years 2 months

Documentation Specialist, Regulatory Affairs & R&D

Emil Kiessling GmbH

Coordinated regulatory documentation and submissions with global teams and suppliers.
Conducted cosmetic ingredient safety and compliance assessments for various product lines.

Jan 2008 - Dec 2014

7 years

Quality Specialist

Tempo Team / Expertime GmbH

Worked across various firms, including Boehringer Ingelheim, Abbott GmbH, Rose Europe, Cinvention, Dr. Köhler Chemie, and Coty, completing quality assurance, research, and development tasks.

Feb 2002 - Dec 2007

5 years 11 months

Quality Control Microbiology

Sandoz Industrial Products GmbH

Carried out environmental monitoring, investigation, and prevention of microbiological contamination in cleanrooms, testing bioburden from products and water.
Produced specifications and methods and maintained GMP equipment logbooks.
Conducted CAPA and root cause analysis of OOS and deviations, and supported FDA documentation and authority audits.
Substituted in the regulatory affairs department, assisting with DMF authoring and submission.

Feb 1992 - Mar 1997

5 years 2 months

Pharmaceutical Biochemist

Farmacéuticos Lakeside

Performed identification tests using chromatographic procedures (HPLC/UV), sterility, endotoxin, cylinder plate, and turbidimetric methods.
Conducted environmental monitoring, bioburden testing, and validation of methods and equipment.
Managed deviations and CAPAs.
Prepared for successful regulatory audits by authorities in Mexico, Europe, Japan, and the USA; completed six weeks of FDA audit preparation training and ongoing auditor training.

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Pharmaceutical, Cosmetics, Chemical, and Healthcare.

Pharmaceutical

Cosmetics

Chemical

Healthcare

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Research and Development, and Product Development.

Quality Assurance

Research and Development

Product Development

Summary

Experienced Quality Assurance and Regulatory Affairs professional with a proven track record in global regulatory submissions, GMP compliance, and lifecycle management for pharmaceutical, veterinary, and cosmetic products. Skilled in cross-functional collaboration, audit readiness, and process improvement implementation to ensure regulatory compliance and product quality. Demonstrated expertise in ICH, VICH, ISO, FDA, EMA, GMP, and OSCE guidelines, with strong experience in scientific documentation, technical dossier preparation, and regulatory strategy.

Skills

Quality Assurance & Control | Regulatory Compliance & Submissions (Fda, Ema, Ich)
Cmc Documentation & Variations | Gmp Compliance & Audit Readiness
Supplier Management & Technical Agreements | Batch Record Review & Capa/change Control
Product Complaint & Adverse Event Management | Electronic Submission Systems (Veeva Vault, Docubridge)
Ms Office Package
Cosmedos Databank
Docubridge Lorenz
Ecdl Certificate
Nasca Database
Ac-db Regulatory
Nl Sales
Sap Materials And Databank
Master Control Manufacturing
Miris Databank
Geode
Phenix Quality
Veeva Vault Quality And Regulatory
Google Drive
Sl Sales Forces
Ectd Submissions
Rodis
Ibm As400
Trackwise

Languages

Spanish

Native

German

Advanced

English

Advanced

Education

Oct 2021 - Jun 2023

Rheinische Friedrich-Wilhelms-University of Bonn

Drug Regulatory Affairs · Bonn, Germany

Michoacan University of San Nicolás de Hidalgo (U.M.S.N.H.)

Degree in Pharmaceutical Biochemistry · Pharmaceutical Biochemistry · Morelia, Mexico

Certifications & licenses

cGMP QMS 8 Hour Boots Camps “GMP From the Auditor´s Perspective”

The Auditing Group and GMP Publications

Pharmaceutical Technology Transfer and Project Management. “Cobblestone”

International Accreditors for Continuing Education and Training (IACET)

RAPS Certificate Workshop on Root Cause Investigation for CAPAS

Elemed's Mentoring Academy for Regulatory Affairs Professionals

Bio cleaning: Cleaning and decontamination of surfaces

Key2 Compliance (Sweden)

RAPS Certificate Intermediate Medical Writing Pharmaceutical and Biologics

RAPS University

Pharmaceutical Regulatory Affairs Certificate

Regulatory Affairs Professionals Society RAPS

GMP-Compliance Program

Sandoz Industrial Products, Frankfurt Höchst

GMP in Technology (Qualification/Validation)

Aventis Pharma Germany, Frankfurt Hoechst

ECDL Certificate

Statistics

Experience

Total positions 10

Experience in Pharmaceutical 23.5 y

Avg length 2 y 9 m

Longest experience 6 y 11 m

Expertise

Recent roles Senior Specialist, Global Regulatory Affairs (CMC Site-to-Site Transfer), Regulatory Affairs CMC Manager, Quality Manager – Complaints

Main industries Pharmaceutical, Cosmetics, Chemical

Main business areas Quality Assurance, Research and Development, Product Development

Qualifications

Highest degree Doctorate

Certifications earned 10

Profile

Created

March 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Maria based?

Maria is based in Mainz, Germany.

What languages does Maria speak?

Maria speaks the following languages: Spanish (Native), German (Advanced), English (Advanced).

How many years of experience does Maria have?

Maria has at least 27 years of experience. During this time, Maria has worked in at least 10 different roles and for 10 different companies. The average length of individual experience is 3 years and 8 months. Note that Maria may not have shared all experience and actually has more experience.

What roles would Maria be best suited for?

Based on recent experience, Maria would be well-suited for roles such as: Senior Specialist, Global Regulatory Affairs (CMC Site-to-Site Transfer), Regulatory Affairs CMC Manager, Quality Manager – Complaints.

What is Maria's latest experience?

Maria's most recent position is Senior Specialist, Global Regulatory Affairs (CMC Site-to-Site Transfer) at MSD Animal Health GmbH.

What companies has Maria worked for in recent years?

In recent years, Maria has worked for MSD Animal Health GmbH, Hennig Arzneimittel GmbH, Boehringer Ingelheim (via Brunel temporary agency), and Sanofi Aventis Frankfurt Höchst.

Which industries is Maria most experienced in?

Maria is most experienced in industries like Pharmaceutical, Cosmetics, and Chemical. Maria also has some experience in Healthcare.

Which business areas is Maria most experienced in?

Maria is most experienced in business areas like Quality Assurance, Research and Development, and Product Development.

Which industries has Maria worked in recently?

Maria has recently worked in industries like Pharmaceutical.

Which business areas has Maria worked in recently?

Maria has recently worked in business areas like Quality Assurance and Product Development.

What is Maria's education?

Maria holds a Doctorate in Drug Regulatory Affairs from Rheinische Friedrich-Wilhelms-University of Bonn and a Bachelor in Pharmaceutical Biochemistry from Michoacan University of San Nicolás de Hidalgo (U.M.S.N.H.).

Does Maria have any certificates?

Maria has 10 certificates. Among them, these include: cGMP QMS 8 Hour Boots Camps “GMP From the Auditor´s Perspective”, Pharmaceutical Technology Transfer and Project Management. “Cobblestone”, and RAPS Certificate Workshop on Root Cause Investigation for CAPAS.

What is the availability of Maria?

Maria will be available from May 2026.

What is the rate of Maria?

Maria's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.