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Katia Simão Email & Phone Number
Regulatory Affairs Manager
at
Cencora
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✓ Verified May 2026
3 data sources
Profile completeness 100%
Current company
Role
Regulatory Affairs Manager
Location
Montreal, Quebec, Canada
Company size
Who is Katia Simão? Overview
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Quick answer
Katia Simão is listed as Regulatory Affairs Manager at Cencora, a company with 26687 employees, based in Montreal, Quebec, Canada. AeroLeads shows a matched LinkedIn profile for Katia Simão.
Katia Simão previously worked as Regulatory affairs specialist at Straumann Group and Regulatory Affairs Project Manager at Knight Therapeutics Inc.. Katia Simão holds Bacharel Em Farmácia E Bioquímica, Farmácia from Centro Universitário Nove De Julho.
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Email format at Cencora
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Cencora
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Profile bio
About Katia Simão
More than ten years of experience in regulatory affairs, considering the last 3 years in Regulatory Affairs environment related with new drugs, established products, generic, brand generic and biological products (new registration, lifecycle procedures and annual report) and the first seven years in Regulatory CMC/cGMP activities at the manufacturing site of a global pharmaceutical company (including activities as lifecycle procedures, compliance procedures, annual report and cGMP activities) with human health products for Brazil and LatAm markets and animal health products for USA, Europe and ROW markets.My experience is based in all regulatory activities, as the technical evaluation and preparation of regulatory filing (for new drugs, annual reports, renewal, lifecycle changes, labelling, responses to regulatory deficiencies, etc) for new products, generic and biologics.I also have experience with LatAm regulatory environment and international guidelines (ICH, CTD and pharmacopoeias, etc).
Listed skills include Microsoft Excel, Microsoft Word, Powerpoint, English, and 5 others.
Current workplace
Katia Simão's current company
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Cencora
9 roles
Katia Simão work experience
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Regulatory Affairs Specialist
Current
May 2023 - Present
Regulatory Affairs Project Manager
May 2022 - May 2023
Regulatory Affairs Specialist
Jun 2021 - May 2022
Senior Regulatory Affairs Specialist
Jul 2020 - May 2021
Latam Sr. Regulatory Affairs Analyst
- Responsible for management of the preparation and evaluation of regulatory dossiers for registration, annual report, renewal and prior approval changes for generic products, biologic products, food supplements.
- Evaluation of change requests started by the manufacturing site, checking the regulatory relevance of them;
- Responsible for the management, investigative process, preparation and/or review for CMC responses to HA (Health Authority) deficiency letters;
- Responsible for the maintenance of regulatory database and regulatory compliance;
- Contact with local or international suppliers and stakeholders;
- Responsible for elaboration and revision of leaflet and carton information;
Sep 2017 - Apr 2019
Regulatory Cmc Specialist - Latam
- Pre-evaluation of new change requests started by the external/contract manufacturing operation/CMO manufacturing site (checking the regulatory relevance for Brazil and LatAm countries) based on current legislation;
- Support ESO (External Supply Operation) team in generation of effective change control strategies particularly when changes affect more than one country;
- Responsible for activities as a Reg CMC, organizing the filing dossiers to accomplish with renewal, annual report, prior-approval changes and responses to Health Authority (HA) questions including CTD documentation;
- Manage, prepare and/or review CMC responses to HA deficiency letters for ESO products;
- Maintain close contact with local and regional DRA for all activities in order to follow regulatory trends and requirements;
- Follow up activities to accomplish with all regulatory commitments for all markets supported by ESO team (LatAm markets);
Sep 2016 - Sep 2017
Senior Regulatory Affairs /Cmc Analyst
- Responsible for activities as a CNM (compliance network member) organizing filing dossiers to accomplish with new registration, renewal, annual report, prior-approval changes and responses to HA deficiency letters for.
- Responsible for development and management of the internal database for regulatory renewal and annual report for all products supported by the team (about 40 products manufactured locally and 70 imported products);
- Follow up activities to accomplish with all regulatory commitments for all markets supported by the site (about 70 markets including Brazil, USA, Europe, LatAm);
- Responsible for attending HA auditors for license renewal and for issues related to controlled products (as psychotropic), providing regulatory support during GMP inspections;
- Review site manufacturing/GMP documentation to ensure the regulatory compliance with the registered information and current regulations;
- Regulatory evaluation/review of all change requests started by the site (defining the actions/documents needed for compliance with the impacted markets);
Jan 2010 - Sep 2016
Analista De Assuntos Regulatórios
Meizler Biopharma S/A
Apr 2007 - Dec 2009
1 education record
Katia Simão education
FAQ
Frequently asked questions about Katia Simão
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What company does Katia Simão work for?
Katia Simão works for Cencora.
What is Katia Simão's role at Cencora?
Katia Simão is listed as Regulatory Affairs Manager at Cencora.
Where is Katia Simão based?
Katia Simão is based in Montreal, Quebec, Canada while working with Cencora.
What companies has Katia Simão worked for?
Katia Simão has worked for Cencora, Straumann Group, Knight Therapeutics Inc., Dental Wings, and Pra Health Sciences.
How can I contact Katia Simão?
You can use AeroLeads to view verified contact signals for Katia Simão at Cencora, including work email, phone, and LinkedIn data when available.
What schools did Katia Simão attend?
Katia Simão holds Bacharel Em Farmácia E Bioquímica, Farmácia from Centro Universitário Nove De Julho.
What skills is Katia Simão known for?
Katia Simão is listed with skills including Microsoft Excel, Microsoft Word, Powerpoint, English, Windows, Research, Outlook, and Gmp.
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