About the role

Aplyr's Quick Take

This role is focused on regulatory affairs for OTC drugs in the EU, primarily involving submission management, document preparation, and coordination with cross-functional teams. It's an individual contributor position that requires attention to detail and compliance with regulatory standards.

Good fit

Ideal candidates have a background in regulatory affairs or a related field, with a few years of experience in drug registration processes. A proactive working style and ability to manage multiple tasks will help you thrive here.

Worth noting

The role involves significant collaboration with regional teams and requires strong organizational skills to track submissions and renewals. The emphasis on compliance and regulatory documentation may be a red flag for those looking for a more creative or less structured environment.

Submission support:

Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc.
Support for the registration of OTC drugs in EU countries.
Support regional RA team to compile submission packages.
Prepare cover letter, application form and relevant Module 1 documents for variations.
Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA.
Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing.
Work with regional 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 LRA’s for submission documents and verification of packages.
Updating relevant submission tracker i.e. J tracker, HAQ tracker, PSMF tracker etc.

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.

CFI support:

Review and edit the consolidated CFI independently and with applying critical thinking and common sense
Make sure that all the regulatory actions provided in the consolidated CFI fit for purpose (i.e. meet requirements of GVP module VII.B.5.1 to 4) and are written in such a way that it can be directly copied into the aggregate report
Challenge LOC if their contribution is not appropriate
Review the regulatory contribution in the draft and final aggregate report based on the outcome of the consolidated CFI
Submit the PSUSA and follow until completion
Submit the post PSUSA variations

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., 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.

Skills & Tags

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Aplyr's read

ClinChoice is a dynamic global CRO catering to the pharmaceutical and biotech sectors, attracting professionals skilled in regulatory affairs, biostatistics, and clinical programming.
Synthesized from recent postings & public sources

What's promising

•ClinChoice offers a diverse range of roles in clinical research, appealing to specialists in biostatistics and regulatory affairs.
•The company provides opportunities for remote and hybrid work, offering flexibility to its workforce.
•ClinChoice's global presence allows employees to engage with international projects and clients.

What to watch

•Limited public information about ClinChoice's workplace culture and employee satisfaction.
•The company may face competition from larger CROs with more established reputations.
•Potential candidates might find limited career advancement information publicly available.

Why ClinChoice

•ClinChoice focuses on comprehensive services across pharmaceuticals, biotechnology, and medical devices.
•The company has a strong emphasis on statistical programming and regulatory affairs roles.
•ClinChoice's recent hiring trends show a commitment to remote and hybrid work models.

Aplyr’s read is generated by AI from public sources. Was it useful?

About ClinChoice

ClinChoice

clinchoice.com

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ClinChoice is a global clinical research organization (CRO) that provides comprehensive services to the pharmaceutical, biotechnology, and medical device industries.