Summary
Overview
Work History
Education
Skills
Websites
professional development
Languages
Timeline
Generic
INNOCENT MOGIDA

INNOCENT MOGIDA

Summary

Insightful Manager with experience directing and improving operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, market trends and regulatory requirements of industry operations. Talented leader with analytical approach to business planning and day-to-day problem-solving.

Overview

23
23
years of professional experience

Work History

Senior Labeling Manager

Lonza
01.2021 - Current
  • Increased team productivity by implementing streamlined processes, Labeling compliance and effective communication strategies.
  • Facilitated successful cross-functional collaborations for the completion of key projects, fostering strong working relationships among team members.
  • Streamlined and monitored quality programs to alleviate overdue compliance activities.
  • Hight knowledge of chemical regulation and classification labeling and packaging.
  • Thorough knowledge of labeling compliance and US-phrase, NDC number requirement

Senior Regulatory Affairs Manager

B. Braun Medical AG
06.2019 - 08.2020
  • International Chemical Notification - the leading contract research organizations providing preclinical and safety Toxicology & chemical testing globally
  • Streamlined submission processes for improved efficiency and timely approvals from regulatory agencies.
  • Oversaw timely preparation and submission of high-quality documentation for product registrations and renewals.
  • Assisted with regulatory product compliance initiatives such as Hospital care registration.
  • CMC experience in the development and manufacturing

GROUP REGULATORY AFFAIRS MANAGER

Omya International AG
12.2008 - 03.2019

Managed risk assessments and mitigations, resulting in a reduction of potential compliance issues.

  • Spearheaded training initiatives for staff on regulatory affairs topics, promoting a culture of continuous learning.
  • Maintained comprehensive knowledge of regional regulations, aiding in the adaptation of strategies across international markets.
  • Directed documentation efforts to comply with domestic and international regulations and standards.
  • Knowledge of IND/ CTD/eCTD requirements and NDC code notification
  • Managed all regulatory needs for products such as EU 10/2011, GB9685 -2016 (China), Swiss ordinance, Food regulation EU 2015/2283 and U. S. Food and Drug Administration (FDA)
  • Trained staff in regulatory policies or procedures.

Organic Chemistry Laboratory Technician

RCC Ltd (ENVIGO++++)
03.2001 - 02.2007
  • Planning and implementation of laboratory and field trials to clarify the chemodynamic behavior of drugs, formulations and applications, especially with plants using modern analytical methods as solid phase extraction, columns, HPLC chromatography, LC/MS/MS, GC/MS/MS, UV; IR and NMR -GLP and Project planning and coordination
  • Streamlined communication between researchers working on related projects by fostering a collaborative environment and implementing regular meetings to discuss progress and challenges.
  • Tested titration of chemical tanks in production line to check for ideal pH and other chemical levels and balance ratios.
  • Provided technical support for instrument troubleshooting, calibration, and maintenance, ensuring optimal performance during experiments.

Education

Master of Science in EU Regulatory Affairs -

Danube University of Krems (Austria)
2018

Bachelor of Science - Chemistry

Open University
Milton Keynes, Buckinghamshire UK
2013

High School Diploma -

The Open University
Milton Keynes, Buckinghamshire UK
2006

Skills

  • Regulatory intelligent on anticipated regulation
  • Fostering interdisciplinary Team collaboration
  • Deadline focus and project manager to implement changing in regulation
  • Team Leadership
  • Staff Training and Development
  • Cross-functional Teamwork
  • Training and Development
  • Strategic Planning

professional development

  • 2018 eRgulatory Affairs certified
  • 2017 Pharmaceuticals: Compliance and Audits (Certificates). Regulation of US and EU Biologics (Certificates) Role of the Regulatory Professional (Certificates) Medical Devices: Postmarket Surveillance (Certificates) Pharmacovigilance (Certificates) Good Clinical Practice (GCP) (Certificates)
  • 2016 Regulatory Affairs Strategies

Languages

English
Bilingual or Proficient (C2)
Swiss German
Upper intermediate (B2)
German
Advanced (C1)
French
Intermediate (B1)

Timeline

Senior Labeling Manager

Lonza
01.2021 - Current

Senior Regulatory Affairs Manager

B. Braun Medical AG
06.2019 - 08.2020

GROUP REGULATORY AFFAIRS MANAGER

Omya International AG
12.2008 - 03.2019

Organic Chemistry Laboratory Technician

RCC Ltd (ENVIGO++++)
03.2001 - 02.2007

Master of Science in EU Regulatory Affairs -

Danube University of Krems (Austria)

Bachelor of Science - Chemistry

Open University

High School Diploma -

The Open University
INNOCENT MOGIDA