Hub Submission Manager

Job Title: Hub Submission Manager

Location: Sandwich, Kent - UK (Onsite)

Duration: 06 months contract

Key Responsibilities

• Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate.
• Partner with product teams and/or third-party partners for project management of activities supporting regional and national regulatory submissions component build and delivery.
• Deliver project-specific electronic and paper regulatory submissions, including coordination and execution of solutions that meet unique submission and national market requirements.
• Manage product delivery to regulatory agencies and ensure subsequent archival.
• Liaise with Project Teams and country representatives to ensure paper and electronic submission requirements, translation requirements, and timelines are understood and aligned with corporate standards and deadlines.
• Lead and participate in the definition, investigation, and implementation of national, regional, and global process efficiencies for paper and electronic submission execution.
• Complete assignments and tasks associated with electronic and paper submissions.
• Interpret regulatory guidelines to produce business requirements and ensure implementation where appropriate at local level.
• Lead the interpretation of regulatory guidelines and support implementation of business requirements.
• Forecast and manage project-specific resources utilizing flexible resourcing and global load sharing practices.
• Manage own time to meet objectives and plan resource requirements (people, financial, and technology) across projects.
• Adhere to the appropriate use of technical tools, working practices, and QC/QA regimes to maintain regulatory and internal compliance.
• Operate as a Subject Matter Expert in dossier types and/or processes, providing training and mentoring to colleagues.
• Escalate, communicate, and resolve issues that may impact submission builds or global submission delivery logistics.
• Promote the use of Document Management and Archival systems and standard document authoring and publishing processes.
• Function as a change agent demonstrating regulatory knowledge, technical competence, sound judgment, and professional demeanor.
• Engage submission leaders, business suppliers, and regional representatives to support opportunistic re-use of submission documentation for multiple national markets.
• Provide guidance and lead moderately complex submission and process improvement projects, making decisions independently.
• Serve as a technical resource within the group.
• Facilitate agreements and drive progress during work team meetings through informal leadership.
• Lead Lessons Learned sessions and implement improvements in partnership with the Dossier Excellence Team.
• Serve as RIO representative in Health Authority meetings and industry discussions/initiatives.
• Contribute to policy and strategy changes to meet evolving business needs.
• Self-initiate assignments, develop innovative solutions to resolve complex problems, and lead project execution.
• Operate as a delegate for RIO leadership as required.

Required Skills & Experience

• Demonstrated experience coordinating activities in a highly regulated environment.
• Proven project management and logistics capabilities.
• Experience working in a challenging customer service environment.
• Proven ability to manage or deliver through others in a team environment.
• Strong attention to detail.
• Experience with electronic submission builds within the Pharmaceutical Industry.
• Understanding of applicable filing regulatory guidelines and regulatory dossier presentation requirements.
• Formal training in technical tools.
• Knowledge of the drug development process.
• Ability to manage multiple highly complex projects simultaneously.
• Strong knowledge of Regulatory Sciences and Global Regulatory & International Operations.
• In-depth understanding of systems and electronic technologies supporting submission and planning activities.
• Experience in process development and implementation of new technologies.
• Ability to influence, mentor, and collaborate across organizations.
• Advanced knowledge of regulatory processes, systems, and guidance.
• Demonstrated ability to lead and deliver through others in a matrix environment.
• Ability to make timely decisions in ambiguous or urgent situations.
• Strong organizational management skills.
• Proven ability to embrace new technologies, processes, and drive implementation.

Qualifications

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

For workers in the United States, PrideGlobal and it's affiliates offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.

Equal Employment Opportunity

PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.

Fair Chance Employment

PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.

Accommodations

We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.

Only applicable for San Francisco Candidates:

Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.

Only applicable for Kentucky positions:

For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.

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