Director Of Regulatory Operational Excellence

Gsk Plc

10+ years

Not Disclosed

10 Jan. 21, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director of Regulatory Operational Excellence
Location: Poznan Grunwaldzka, Poland; London, United Kingdom; Stevenage, United Kingdom
Category: Regulatory
Job ID: 410616
Posted Date: January 7, 2025
Closing Date for Applications: January 24, 2025 (COB)

About GSK

GSK is a global biopharmaceutical company with a special purpose: to unite science, technology, and talent to get ahead of disease together. Our mission is to positively impact the health of billions of people, delivering stronger, more sustainable shareholder returns while creating an environment where people can thrive.

We focus on four core therapeutic areas:

Infectious Diseases
HIV
Respiratory/Immunology
Oncology

Our success depends on our people. We strive to create a place where individuals feel inspired, encouraged, and challenged to be their best selves. GSK promotes an inclusive culture that values diversity and encourages growth and well-being.

Our Hybrid Working Model

Through our Performance with Choice program, we support a hybrid working model, allowing employees to balance remote and in-office work.

Role Overview

We are seeking a Director of Regulatory Operational Excellence to lead and implement strategic continuous improvement initiatives within the Global Regulatory Affairs (GRA) function. In this leadership role, you will drive improvements across key areas including project management, data analytics/visualization, third-party management, and resource allocation. Your efforts will optimize operational efficiencies, enhance compliance, and provide greater visibility into team performance.

This is a critical role to ensure the GRA practices evolve and adapt to meet the demands of an ever-changing, fast-paced environment.

Key Responsibilities

Strategic Leadership: Develop and implement a regulatory operational excellence strategy that aligns with the GRA’s goals, focusing on project management, data analytics/visualization, third-party management, and resource allocation.
Project Management: Enhance methodologies to ensure successful regulatory project delivery and drive continuous improvement.
Budget Management: Oversee functional budgets, collaborating with the GRO Leadership Team, Finance, and Tech partners to optimize resources and ensure financial alignment.
Analytics Framework: Lead the creation of key performance indicators (KPIs) and establish a robust analytics framework to generate actionable insights for better decision-making.
Resource Allocation: Manage and review resource allocation strategies with leadership to ensure the optimal utilization of personnel and resources.
Operational Excellence: Serve as the primary contact for operational excellence matters, providing updates to senior leadership, promoting continuous improvement, and fostering best practices across teams.

Basic Qualifications & Skills

We are looking for professionals with the following skills and experience:

Educational Qualifications: Degree in a scientific or technical specialization.
Project Management & Data Analytics: Extensive experience in project management and data analytics, including overseeing and prioritizing multiple projects for various stakeholders.
Pharmaceutical Experience: Strong understanding of pharmaceutical drug development and global regulatory procedures.
Independent & Effective Communication: Ability to work independently while effectively communicating across all levels within GSK to ensure on-time delivery of objectives and projects.
Collaborative Mindset: Demonstrated ability to break down silos, drive collaboration, and optimize organizational benefits.
IT Systems Experience: Proven ability to work within complex IT systems in a regulated environment.
Leadership Skills: Strong leadership experience in managing and motivating teams through change in matrixed environments.

Preferred Qualifications & Skills

Although not essential, the following qualifications are preferred:

Educational Qualifications: BSc (or equivalent) in a scientific or technical discipline.
Regulatory Affairs Expertise: Strong understanding of Regulatory Affairs functions and roles within GRA, both centrally and locally.
Exceptional Communication: Ability to convey messages with clarity, impact, and passion, both written and orally.

Why GSK?

At GSK, we offer a comprehensive range of benefits, including:

Competitive Salary and Annual Bonus based on company performance.
Healthcare & Wellbeing Programs to support physical and mental health.
Pension Plan and Shares & Savings Programs to secure your financial future.
Hybrid Working Model through our Performance with Choice program, allowing you to balance work between home and the office.

GSK fosters an inclusive, diverse, and supportive environment for all employees. We are dedicated to creating a place where people can thrive both professionally and personally.

Equal Opportunity Employer

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, veteran status, or any other protected class.

Application Instructions

To apply for this role, please submit a cover letter and CV outlining how you meet the competencies for this position. The information in your cover letter and CV will be used to assess your application.

Important Notice to Employment Agencies

GSK does not accept unsolicited referrals from employment agencies. Employment agencies must contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before submitting candidates for any open positions. Failure to do so may result in no compensation for the referral.

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Director Of Regulatory Operational Excellence

Job Description

About GSK

Our Hybrid Working Model

Role Overview

Key Responsibilities

Basic Qualifications & Skills

Preferred Qualifications & Skills

Why GSK?

Equal Opportunity Employer

Application Instructions

Important Notice to Employment Agencies

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