At a Glance
- Tasks: Develop regulatory strategies and provide guidance for product development in the Consumer Health sector.
- Company: Leading multinational Consumer Health client with a hybrid work model.
- Benefits: Competitive salary, flexible working, and opportunities for professional growth.
- Other info: Exciting opportunity to work on innovative projects with a focus on compliance and quality.
- Why this job: Join a dynamic team and influence product compliance across the EMEA region.
- Qualifications: 6-8 years of experience in regulatory affairs and a relevant degree in Life Science or Chemistry/Biology.
The predicted salary is between 50000 - 60000 £ per year.
PE Global are currently recruiting for a Regulatory Affairs Specialist for an initial 6 month contract role with a leading multinational Consumer Health client based in Reading – hybrid (2/3 days per week in the office).
Responsible for the development of CMC/technical regulatory strategies across the EMEA region providing regulatory input and technical guidance on regional regulatory requirements to product development teams within the Self Care franchise.
Responsibilities:- Provides strategic regulatory input and technical guidance on regional regulatory requirements to product stakeholders within LCM and growth & innovation.
- Participates in cross-functional project teams to define development program requirements and risks.
- Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines in EMEA.
- Maintains awareness of current regulations and anticipates implications and opportunities because of changes to the relevant regulatory environments.
- Communicates changes to appropriate management and cross functional experts as appropriate.
- Ensures that all products comply with local regulatory and quality system requirements.
- Ensures quality and compliance in all actions.
- Participates in the development and implementation of, and maintains compliance with, all applicable Processes.
- Ensures that the enterprise Regulatory systems are accurate and fully maintained.
- Ensures any compliance issues are reviewed and escalated, and relevant corrective/preventative actions are implemented locally.
- Identifies and/or implements regional process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
- Evaluates deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks.
- Requires 6-8 Years Work Experience.
- Relevant Bachelor's Degree or higher in Life Science or Chemistry/Biology.
- Expertise of EU WS and MR-DC in line with the Pharmaceutical Directive and associated guideline.
- Specific skills in management of EU procedures are a must.
- Desirable to have experience in leading early-stage innovation RA deliverables such as determining classification status, regulatory strategy for medicinal products and implementation of the strategy.
- Knowledge of regulatory frameworks and external environments in the EU and wider EMEA, and the ability to apply these to regulatory solutions throughout the product lifecycle.
- Strong project management skills.
Interested candidates should submit an updated CV.
Regulatory Affairs Specialist in Slough employer: PE Global
PE Global is an exceptional employer, offering a dynamic work environment in Reading that fosters collaboration and innovation within the Consumer Health sector. With a strong emphasis on employee growth, we provide opportunities for professional development and encourage participation in cross-functional teams, ensuring that our Regulatory Affairs Specialists are at the forefront of industry advancements. Our hybrid working model promotes a healthy work-life balance, making PE Global a rewarding place to build a meaningful career.
