Senior Regional Regulatory Affairs Specialist
Skills: Regulatory Affairs
The Senior Regional Regulatory Affairs Specialist is responsible to support regional regulatory tasks for a range of investigational and licensed products in one Regional Therapeutic Area. This role involves working closely with Regional Regulatory Managers, Scientists or Therapeutic Area Leads primarily on operational activities and projects.
The senior specialist will support the Global Regulatory Affairs (GRA) vision of excellence through good scientific practice, integrity and consistent compliance with regulatory standards. The incumbent closely cooperates with specialists of other GRA functions at the same or at other sites. The incumbent may establish and maintain effective working relationships with respective Regional / Local Regulatory Managers of Affiliates or Regulatory Agents, as required.
1. Under the direction of Regional Regulatory Manager(s) and Therapeutic Area Lead:
- Support the compilation and submission of high quality documentation such as new license applications, change applications, labeling submissions, license renewals, clinical trial applications/INDs, pediatric plans, orphan drug designations, product identifiers/names, tenders, periodic reports, health authority meetings etc. in accordance with agreed schedules, taking into account regional specific requirements.
- Support in the strategy, planning and preparation of health authority documents.
- Assist in reviewing technical and/or scientific information for compliance with regional regulatory requirements and interpretations, identifying deficiencies and when needed, proposes solutions to remediate the risks.
- Gathers and assembles information necessary for submissions in accordance with
regulations and relevant guidelines, i.e., investigate country specific regulatory requirements regarding layout, structure and dossier type (eCTD, NEES, pdf, etc.).
- Provide established regional templates to team members as needed.
- Draft non-CMC parts of application forms for review by Regulatory Manager and/or Scientist.
- Performs review for completeness and format check of dossier narratives or briefing packages.
- Prepares checking/tracking lists, monitors timelines and if necessary, requests submissions documents from other functions.
- Coordinate country specific Module 1 documents with Regional / Local Regulatory Managers of Affiliates or Regulatory Agents, as applicable.
- Manage documents /document update workflows in the applicable document management system e.g. Submission Repository or DocNet.
- Assist in obtaining/creating regional statements.
- Collect and submit lot distribution data and prepare applications for , GMP license / certificates, Certified Products Details, Certified Pharmaceutical Products etc., as needed.
- Create / update Apollo submission tracker.
- Upon request, perform quality check of published output.
- In a timely manner, dispatch of relevant regulatory documentation to the Regional Regulatory Affairs Manager/Local Regulatory Affairs Manager (RRM/LRM) or submit to the Health Authorities according to country specific requirements, as needed.
- Support the coordination & logistics of HA meetings and the preparation of related materials (slides, visio, excel sheets, etc.).
- Monitor due dates of license renewals, commitments and annual reports.
- Monitor the EU sunset clause requirements, as applicable.
- Timely inform the Planning & Tracking Team on required regional related entries / updates.
- Communicate procedural timelines to stakeholders, as applicable.
- Serve as a point of contact for RRMs/LRMs, as applicable.
- Upon request, support collection of Regulatory and Competitive Intelligence Information by monitoring HA and competitor sites (e.g., labeling, SBORA) and prepare comparative materials.
- Upon request, assist in the coordination of the regulatory guideline review process.
- Collaborate with subject matter experts in the preparation of relevant labeling, e.g. container labels, cartons or package inserts as required for new submissions, revisions to labeling or as a result of responses to regulatory questions on the labeling.
- Ensure that the relevant labeling claims are appropriately referenced and documented with the technical evidence from subject matter experts.
- Work with the GRA Regional product specialists/managers and/or publishing group(s) to ensure the timely submission of the labeling or responses to the regulatory authorities.
Coordinate regulatory and operational departments’ activities to ensure timely printing of the labeling for the relevant country.
- Support the preparation of standard operating procedures / work instructions / best practices as needed.
- If applicable, check invoices for submissions from HAs and countries in the relevant region.
- Ensure translation of HA approval letter from local language to English.
- Assist in the maintenance of SharePoints.
- Work with the team leads or delegate to monitor and/or create the metrics/statistics, reports etc. for presentation purposes.
- Serve as backup to department administrator for the HA fax email box (distribute to appropriate product manager for further distribution and files communication according to internal processes)
- Support the training of new Regional Regulatory Affairs Specialists, as needed.
- Support the training of managers and above within their therapeutic area in specific operational activities such as, Apollo entries, etc.
Position Qualifications and Experience Requirements:
- Bachelor in Science-Related Discipline or 3 years apprenticeship as Medicinal Documentation Professional or equivalent. An advanced degree in scientific discipline would be beneficial.
- Function-related training in Regulatory Affairs.
Experience: At least 3 years professional experience in Regulatory Affairs
- Basic knowledge of drug development, or paramedical, and/or biological sciences.
- Experience with, or demonstrated ability to learn new regulatory requirements.
- Effective communication skills, both written and verbal.
- Strong organizational and problem solving skills, with the ability to prioritize workload with limited instruction.
- Flexibility to work independently and in teams in a global matrix organization.
- Strong interpersonal skills with a demonstrated ability to develop collaborative, constructive and effective relationships.
- Microsoft Office, Documentum etc.
- Fluent in English