Regulatory Affairs Specialist (Hub Submission Manager)

Job Title: Regulatory Affairs Specialist (Hub Submission Manager)

Location: Sandwich, Kent

Duration: 12 Months

WorkType : Hybrid

Overview:

TekWissen is a global workforce management provider throughout the UK, Europe and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation.

Job Description:

ROLE SUMMARY

• Summarize the primary purpose & key accountabilities of the job.
• The Hub Submission Manager is accountable for operational management of regional and/or national regulatory
• dossiers to designated Health Authorities (HA’s).
• Based within GRS Global Regulatory & International Operations, this role sits within a team working to tight, businesscritical
• deadlines within a highly regulated environment. Primary focus is on allocated region/ countries, with
• additional responsibility to support other locations through utilization of global tools.
• On behalf of Global Regulatory Sciences (GRS), lead and manage logistical and technical aspects, ensuring
• development and delivery of X-regional, regional and/or national regulatory dossiers – initial application and
• subsequent lifecycle updates (compliance and maintenance).
• Execute, through use of standards and tools, designated operational tasks e.g. submission planning, document
• receipt, translation management, technical build and submittal to HA or via the applicable client country office,
• conforming to regulatory submission milestones and applicable regulatory obligations.
• Given the scope of international work, critical features of this role are the ability to successfully interface with
• multiple cultures and, to recognize and exploit opportunities to use scale, cloning and repurposing dossiers for
• worldwide markets where feasible.
• The HSM may be assigned as a Global Submission Manager to meet business demands. In this capacity, they may
• operate as Subject Matter Expert for a selected portfolio segment.

JOB RESPONSIBILITIES :-

• Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate.Partnering with product teams and/or third-party partners, the incumbent will be responsible for projectmanagement of activities, in support of regional and national regulatory submissions component build and delivery.
• Delivering project specific client electronic and paper regulatory submissions. Including co-ordination andexecution of solutions that meet unique requirements of each submission and national market, management of product delivery to regulatory agencies and ensuring subsequent archival.
• Ongoing liaison with Project Team and country representatives to ensure paper and electronic submission requirements, translation requirements and timelines are mutually understood and in line with corporatestandards and deadlines for dossier delivery to regional and national markets.
• Actively participate in the definition, investigation and implementation of national, regional and globalprocess efficiencies for paper and electronic submission execution, including the evaluation of current processes.
• Completion of assignments and tasks within a specific task force/project associated with electronic and paper submissions.
• Help interpret regulatory guidelines to produce business requirements and ensure that those requirementsare implemented where appropriate at local level.
• Contribute to effective forecasting and management of project specific resources utilizing flexibleresourcing, and global load sharing as normal business practice.
• Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
• Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training andmentoring fellow colleagues.
• Escalates, informs, and resolves any issues that may impact submission builds or the logistics of globalsubmission delivery to regional partners or Health Authorities.
• Promotes the use of Document Management and Archival systems and standard document authoring andpublishing processes, partnering with supplier groups as necessary in order to produce timely delivery ofsubmission/archive ready components. Manager (cumulative from above)
• Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor.
• Engages Submission leaders, business suppliers and other key regional representatives as appropriate, toagree on process and activities for opportunistic re-use of submission documentation for multiple national markets.
• Leads the interpretation of regulatory guidelines to produce business requirements and ensure that thoserequirements are implemented where appropriate at local level.
• Manages own time to meet objectives; forecasts and plans resource requirements (people, financial andtechnology) for projects across Department.
• Provides guidance to and leads moderately complex submission and process improvement projects, makingdecisions independently.
• Considered a technical resource within the group.
• Regularly takes informal leadership role during Work Team meetings to facilitate agreements and move thegroup toward its goals.Senior Manager (cumulative from above)
• Leads Lessons Learned sessions and implements change in partnership with Dossier Excellence Team.
• Serves as client RIO representative with Health Authority meetings, Industry discussions/ initiatives.
• Contributes to changes in policies and strategies to meet evolving business needs.
• Self-initiates assignments, developing innovative ideas to resolve complex problems and leading theexecution of projects.
• Operates as delegate for RIO leadership as required.

QUALIFICATIONS / SKILLS

• Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.

TECHNIAL SKILLS

Senior Associate (qualitative examples)

• Demonstrated coordination of activities in a highly regulated environment.
• Proven aptitude in project management and logistics.
• Demonstration of experience working in a challenging customer service environment.
• Proven experience managing or delivering through others in a team environment.
• Demonstrated attention to detail.
• Relevant experience in electronic submissions build within the Pharmaceutical Industry.
• Understanding of applicable filing regulatory guidelines and fluency regarding order and presentation ofregional and national regulatory dossiers.
• Formal training in technical tools.
• Knowledge of drug development process.Manager (qualitative examples)
• Ability to work on multiple highly complex projects simultaneously.
• Strong knowledge of the drug development process, regulatory sciences, and Global Regulatory &International Operations.
• In depth understanding of systems and electronic technologies used to support submission and planningactivities, as well as demonstrated experiences in process development and new technologyimplementation.
• Ability to operate seamlessly and influence/mentor direct and indirect reports, as well as acrossorganizations.Senior Manager (qualitative examples)
• Significant knowledge of the drug development process, Regulatory Sciences and Global Regulatory &International Operations.
• Advanced knowledge of the processes, systems and regulatory guidance and a detailedunderstanding/knowledge of principles and concepts of other disciplines.
• Demonstrated ability to lead and deliver through others in a matrix model.
• Demonstrated ability to deliver swift decision in ambiguous or urgent circumstances.
• Robust organizational management skills.
• Proven ability to embrace new technologies and processes and drive their implementation.

QUALIFICATIONS

• B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevantprofessional experience will be considered.
• Proven technical aptitude and ability to quickly learn and use new software, regulations and qualitystandards.
• Multi-lingual skills desirable.
• Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.

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