Gra Health Senior Associate Medicinal Active
17 hours ago
**Global Regulatory Senior Associate, Compliance Operations Active Pharmaceutical Ingredients (API’s)**
**Kingston upon Hull, East Yorkshire, hybrid working**
**Competitive Salary & excellent benefits package**
Working with the Manager Compliance Operations Active Pharmaceutical Ingredients (API’s), you will help to shape the medicinal brands post-launch and be responsible for the end to end delivery and accountability of projects and post-launch activities related to API maintenance.
**You’ll succeed because ** you will have the experience of- Work with the Manager Compliance Operations Compliance Active Pharmaceutical Ingredients (API’s) on the regulatory inputs into supply plans and be part of a team responsible for the maintenance, compliance and supply programme activities across a range of medical brands in relation to the API (Nurofen, Strepsils, Gaviscon, Lemsip).
- Have ownership, responsibility and accountability of the development of the overall regulatory execution plans in markets, ensuring global activities are appropriately impact assessed for implications.
- A critical partner with excellent working relationships across R&D Operations, Supply, Procurement, Quality, Medical teams and local regulatory partners around the world to proactively guide and collaborate through existing regulatory requirements directly affecting our products.
- Is responsible for the efficient and effective execution as well as project management of regulatory API post launch activities, including analysis, planning, development and execution of regulatory strategies to allow successful compliant delivery of projects.
- Support as required other regulatory functions in developing, reviewing and/or executing regulatory activities to strengthen the efficiency and quality of the regulatory function globally.
- Drives, with the support of their line manager, their personal development to ensure outperformance. Develops their regulatory knowledge and contributes to Reckitt regulatory intelligence.
- Operates in line with departmental SOPs and business QMS’s. Contribute to the quality assurance in place in the department (e.g, identify gaps, areas for training and improvement of processes. )
You’ll succeed because
- you’ve a scientific background and you understand Regulatory Affairs. You are:
- Educated to honours degree level in a scientific field or equivalent experience
- Experienced in developing Global Regulatory strategies for maintenance and EPD activities in medicinal products
- Have relevant Regulatory experience and knowledge in eCTD Dossier maintenance and global registrations
- Have knowledge of the Regional and Global regulatory environment and how it impacts regulatory dossiers and registration.
You’ll love it because
you’ll get to make an impact like never before. You’ll be responsible for your own projects - we can’t wait to hear your ideas. The products you help us get out there will make people’s lives better. Our iconic brands will provide an incredible platform for you. And our dynamic, ownership-driven culture will help bring the very best out of you, every day.
**Equality**:
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
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