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Senior Associate / Specialist - CMC, EU-OTC

icon building Company : Clinchoice
icon briefcase Job Type : Full Time

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Job Description - Senior Associate / Specialist - CMC, EU-OTC

Responsibilities:


Submission support:



  • Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc.

  • Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA.

  • Prepare cover letter, application form and relevant Module 1 documents for variations.

  • Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing.

  • Work with regulatory team to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks.

  • Regulatory review of submission documents for compliance.

  • Work with cross-functional teams or local affiliates for submission documents and verification of packages.

  • Updating relevant submission tracker.


 


PSUR submission support: 



  • Review of EURD updates

  • Tracking licenses for DLP and PSUR submission.

  • Review of draft PSUR document for accuracy of the data.

  • Co-ordinate with different stakeholders for safety related information for PSUR

  • Support submission and handling of queries for PSUR


Renewal support:



  • Tracking of licenses for registration and approval.

  • Tracking of approval validity of licenses and renewal timelines.

  • Planning for renewal submission.

  • Co-ordination with cross-functional team for Renewal documentation.

  • Co-ordination with Local RA lead for Renewal documentation and submission.

  • Preparation of Renewal package.

  • Submission of Renewal to health authority and post submission activity.


Deliverables:



  • Provide weekly updates (at a minimum or based on client requirement) to relevant colleagues or Project Manager on project status. Internal & Confidential [not for external circulation]

  • Ensure that regulatory standards and timelines are met for all projects.

  • Planning and tracking the status of ongoing regulatory projects

  • Use of regulatory database and IT tools where relevant.

  • Project review every quarter on performance feedback and scope of improvement.


Experience/Qualifications:



  • Minimum B.S. Chemistry, Biology, or related fields

  • Minimum of 4-5 years of experience working within a Regulatory Affairs Department (e.g., parmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience and specific interactions with a Regulatory Affairs Department by providing source documentation to CMC, Quality, or Regulatory Operations.


 

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