Regulatory Affairs Labelling Operations - Senior Manager - English

Regulatory Affairs Labelling Operations - Senior Manager - English - LIF006357

With a start-up spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently and are bold enough to reinvent it. Come, transform with us. Are you the leader we are looking for? Inviting applications for the role of Regulatory Affairs Labelling Operations - Senior Manager – English! The Labelling Operations Manager (LOM) provides operational support for the initial creation and relevant updates to labelling documents including the Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labelling Documents. The LOM will be knowledgeable of labelling guidance and policies related to technical/formatting (e.g., QRD template, PLR format) and will raise awareness of important factors to consider when revising the label. The LOM provides project management to the Labelling Team throughout the labelling review and approval process through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets, ensuring that Labelling Teams are aware of the review and approval timelines and following up with Labelling Team members throughout the process as appropriate so that deliverables remain on target to meet internal and external deadlines.

Responsibilities Support the review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labelling Documents. The LOM will provide operational support:

• Consolidate labelling versions.
• Consolidate comments from Labelling reviewers and Regulatory Authorities.
• Prepare comparison tables for labelling team discussions.
• Edit and format labelling documents- Ensure the document complies with the appropriate template (e.g., QRD, PLR).
• Generate necessary renditions in GDMS (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate.
• Facilitate workflow through corporate document repository, e.g., GDMS.
• Finalize documents post QC (including update of GDMS document properties such as entry of PfLEET2 number, update of document title, update CDS cover page etc.).
• Manage the document status in GDMS and notify internal stakeholders of the availability of labelling documents.
• Order SPL for USPIs, check and upload to GDMS upon receipt, notify internal stakeholders of its availability (e.g., Regulatory, Drug Listing).

Qualifications we seek in you! Minimum Qualifications

• Pharmaceutical labelling experience
• Knowledge of global/regional regulatory guidelines and requirements important.
• Excellent written and verbal communication skills essential.
• Complete fluency in English Language.
• Proven strength in logical, analytical and writing ability essential.
• Demonstrated project management skills and attention to detail required.
• Identifies and resolves problems in a proactive manner.
• Ability to multi-task, prioritize and manage multiple projects.
• Ability to liaise with stakeholders using effective means of communication. Preferred Qualifications
• Advanced degree in scientific related field

What can we offer?

• Attractive salary;
• Stable job offers - employment contract
• Work in a multicultural and diverse environment with employees from over 30 countries
• Genpact supports langauge courses, professional tranings and great career development opportunities
• Free access to our award-winning learning platform

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.

Job

Senior Manager

Primary Location

United Kingdom-London

Schedule

Full-time

Education Level

Bachelor's / Graduation / Equivalent

Job Posting

Nov 17, 2021, 7:04:34 AM

Unposting Date

Ongoing Master Skills List Operations Job Category Full Time