Regulatory Consultant

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

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 a 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.

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 two years of experience working within a Regulatory Affairs Department (e.g., pharmaceutical, 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