As a Regulatory Affairs Project Manager, you will represent Global CMC Regulatory on Regulatory Networks and Matrix Teams providing regulatory advice and guidance to Medicines Science & Technology, Pharma Supply Chain, Commercial teams, Quality Assurance, 3rd Party Contract Management and Regulatory to produce appropriate CMC components for global regulatory dossiers with appropriate guidance from supervisor, as necessary.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Understand and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Ensure all appropriate CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
- Ensure information submitted in marketing applications meets regional requirements, allowing maximum manufacturing flexibility with minimal unanticipated questions.
- Ensure all appropriate CMC regulatory aspects to support license maintenance and change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.
- Deliver CMC regulatory strategy to support major inspections (eg PAI’s) or quality incidents (PIRCs).Work with subject matter experts to map current and future processes, seek efficiencies, and integrate written standards and training requirements.
- Manage multiple projects and teams simultaneously and provides data assessment and conclusions within and across departments.
- Formulate alternative approaches and influences people, systems and processes.
- Independently identify risks associated with submission data and information packages.
- Contribute to, and lead the creation, maintenance and continuous improvement of CMC Regulatory processes, policies and systems
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in Biochemistry, Pharmaceutical Chemistry or life sciences
- 5+ years of experience in the pharmaceutical industry
- Sound knowledge of biopharmaceutical drug development and manufacturing and supply processes
- Knowledge of worldwide CMC regulatory requirements for biopharmaceuticals
- Successfully managed multiple projects simultaneously.
If you have the following characteristics, it would be a plus:
- Regulatory Affairs Certification (RAPS).
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
- Broad knowledge base across regulatory functions to understand wider implications of emerging issues across projects
- Experience in influencing and negotiating with GSK personnel in a variety of settings.
- Highly developed interpersonal, presentation and communication skills with established internal and external networks
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
As a global healthcare company, we take on some of the world’s biggest healthcare challenges. By delivering a sustainable business, we provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
We are committed to widening access to our products, so more people can benefit, no matter where they live in the world or what they can afford to pay. Each of our three businesses benefits from GSK’s commercial infrastructure, integrated supply networks and significant global presence.
As a global company, our reward packages are designed to meet the needs of our geographically diverse workforce. They are benchmarked against industry standards and relevant to your job, no matter where you live.
Our reward package includes:
- A competitive base salary
- An annual bonus that rewards you for your individual contribution to our strategy, as well as business targets
- Benefit programs designed to support you and your family, including access to healthcare and well-being programs, pension plan membership, savings programs, time off and childcare support
- Employee recognition programs which reward exceptional achievements
- Share ownership schemes which link your reward to GSK’s longer term performance
- A performance and development program that helps you identify what you need to do, and the behaviors you need to demonstrate, to achieve success.