Jakob Simonsen

FAQ About Jakob Simonsen

• What is Jakob Simonsen's address?

  Jakob Simonsen is located at
  Copenhagen, Copenhagen, Denmark

• What is Jakob Simonsen's job title?

  Jakob Simonsen is a
  With over 7 years of expertise in Regulatory Affairs CMC, I specialize in maintaining marketing autorisations for biologics across global markets. I have successfully navigated regulatory landscapes in Europe, the Middle East, Asia, North America, South America, and Africa. Key Achievements: Facilitated manufacturing changes, process validations, changes of analytical procedures, successful upscaling of manufacturing capacities and changes to meet evolving industry standards, updating dossiers of legacy products to obtain new marketing autorisations. Current Role at ALK: As a Senior Regulatory Professional at ALK headquarters, I drive changes within the subcutaneous immunotherapy (SCIT) portfolio. My responsibility includes: - Regulatory Dossier: Writing and maintaining regulatory dossiers, covering Module 1, 2, and 3. - Veeva RIM Implementation: Played a role as CMC expert in the successful implementation of Veeva Regulatory Information Management (RIM) system. - eCTD Submissions: Skilled in preparing and submitting electronic Common Technical Document (eCTD) applications. - Strategic Planning: Expertise in developing regulatory strategies and conducting risk assessments to ensure compliance and market access. - Quality Project Management: Demonstrated ability to lead complex CMC projects from change request, ensuring regulatory approvals and timely implementation. - Authority Contact: Experience in engaging with regulatory authorities, ensuring smooth communication and approvals. - Global Regulatory Compliance: Monitor and act on evolving global regulatory standards, ensuring products meet requirements. Alk

• What industry does Jakob Simonsen currently work in?

  Jakob Simonsen currently works in the
  Alk

• What is Jakob Simonsen's area of expertise?

  Jakob Simonsen specializes in
  With over 7 years of expertise in Regulatory Affairs CMC, I specialize in maintaining marketing autorisations for biologics across global markets. I have successfully navigated regulatory landscapes in Europe, the Middle East, Asia, North America, South America, and Africa. Key Achievements: Facilitated manufacturing changes, process validations, changes of analytical procedures, successful upscaling of manufacturing capacities and changes to meet evolving industry standards, updating dossiers of legacy products to obtain new marketing autorisations. Current Role at ALK: As a Senior Regulatory Professional at ALK headquarters, I drive changes within the subcutaneous immunotherapy (SCIT) portfolio. My responsibility includes: - Regulatory Dossier: Writing and maintaining regulatory dossiers, covering Module 1, 2, and 3. - Veeva RIM Implementation: Played a role as CMC expert in the successful implementation of Veeva Regulatory Information Management (RIM) system. - eCTD Submissions: Skilled in preparing and submitting electronic Common Technical Document (eCTD) applications. - Strategic Planning: Expertise in developing regulatory strategies and conducting risk assessments to ensure compliance and market access. - Quality Project Management: Demonstrated ability to lead complex CMC projects from change request, ensuring regulatory approvals and timely implementation. - Authority Contact: Experience in engaging with regulatory authorities, ensuring smooth communication and approvals. - Global Regulatory Compliance: Monitor and act on evolving global regulatory standards, ensuring products meet requirements.

• Which languages does Jakob Simonsen speak? 

  Jakob Simonsen speaks the following languages:
  No languages available.

• Which industries has Jakob Simonsen previously worked in?   

  Jakob Simonsen has prior experience in the following industries:
  Alk , Aj Vaccines , Statens Serum Institut And Aj Vaccines , Skoletjenesten Kobenhavns Universitet , Apotek Svalen , Ferring Pharmaceuticals , Kobenhavns Kommune , Star Tour , Berlingske , Post Danmark , Advokat Majken Johansen , Svommeklubben Skk

• What is Jakob Simonsen’s work experience?  

  Jakob Simonsen has the following professional experience:
  Alk , Alk , Aj Vaccines , Statens Serum Institut And Aj Vaccines , Skoletjenesten Kobenhavns Universitet , Apotek Svalen , Ferring Pharmaceuticals , Kobenhavns Kommune , Star Tour , Berlingske , Post Danmark , Advokat Majken Johansen , Svommeklubben Skk .

• How can I find Jakob Simonsen on LinkedIn?  

  You can view Jakob Simonsen’s
  LinkedIn profile at LinkedIn URL.

• What are Jakob Simonsen’s work email addresses?  

  Jakob Simonsen’s work email addresses are
  [email protected] .

• What company does Jakob Simonsen work for?  

  Jakob Simonsen works at
  Alk