Regulatory Affairs Specialist Job Description
Job Title: Regulatory Affairs Assistant
Salary Range: Competitive salary based on experience
Working Hours: Full-time, [8:30 AM to 5 PM]
Job Summary:
We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to join our team. The ideal candidate will be responsible for ensuring compliance with regulations and laws governing our industry. This role requires a keen eye for detail, strong analytical skills, and the ability to work collaboratively with cross-functional teams.
Operational Activities:
● Have a clear understanding of the company’s policies and vision and how your role contributesto this.
● Assist the Head of Business Operations and Regulatory with the improvement ofoperational management systems, quality control, processes, and best practices toenhance efficiency and effectiveness.
● Maintain effective relationships with third-party vendors and service providers to ensurethe seamless integration of outsourced activities into the company’s operations.
● Support internal processes (including warehouse) by coordinating meetings, organizingdocuments, and assisting in project management.
● Provide general administrative support, including managing calendars, schedulingappointments, and handling routine inquiries.
● Collaborate with the warehouse team to maintain accurate stock records and when required,help in the coordination of shipments and distribution of pharmaceutical products, ensuringaccurate labeling and documentation.
● Monitor and restock supplies in the office areas, reception, warehouse, restroom, andkitchen.
● Assist in the tracking and inventory management of facility-related supplies andequipment.
● Assist in monitoring warehouse operations area for any defaults such as temperaturedeviations and resolving any issues that may arise promptly.
● Introduce fresh ideas and concepts aimed at enhancing communication, resulting ininnovative solutions for cultivating new customer and supplier relations.
● Immediately inform the line manager of any problems arising in the course of the work.
Regulatory Activities:
● Ensure compliance with regulatory standards is always met, including Good Distribution Practice (GDP) and other industry-specific guidelines.
● Collaborate with the regulatory team to track and manage compliance deadlines and requirements.
● Support the regulatory and management team by executing the bona fide process for newand existing customers and suppliers. Familiarize yourself with the applicable SOPs andoffer suggestions for improvement if needed. Ensure accurate and timely filing ofdocuments.
● Manage the account opening and creation form/process and provide updates to relevantparties on the progress.
● Communicate effectively with internal teams to gather relevant information and ensurealignment with regulatory standards.
● Assist in the communication with external regulatory and competent authorities,ensuring responses and accurate information exchange.
● Help maintain and update procedural documentation related to operations andcompliance activities.
● Support Health and Safety initiatives by ensuring compliance with safety protocols andregulations.
● Such other duties as the management may from time to time reasonably require.Note:
This job description is a guide to the principal and current duties of the job. It does notform part of the contract of employment.
EXPERIENCE & QUALIFICATIONS
● A high school diploma or equivalent, associate or bachelor’s degree in a related field is a plus.
● Familiarity with operational and regulatory requirements relevant to the industry(GDP, etc.)
● Strong organizational skills with exceptional attention to detail.
● Proficiency in using software applications such as Microsoft Office and Inventory Management Systems.
● Excellent communication skills, both written and verbal.
● Ability to work in a fast-paced environment, prioritize tasks, and adapt to changing priorities.
● Previous experience in a pharmaceutical or distribution environment is a plus.
● Willing to learn, collaborate, and contribute to continuous process improvement.
Technical skills and abilities:
● Competent in Data Management (ensuring data integrity andconfidentiality).
● Competent in Document Control (organizing and managing various documents,including filing, SOPs, and compliance reports.
● Regulatory Knowledge (familiarity with industry regulations and compliance requirementssuch as GDP, GDPR, etc.).
Emotional skills and abilities
● Careful and diligent with strong attention to detail.
● Pride and sense of ownership in their working domain.
● Strong self-discipline.
● Flexible approach to work and the tasks to be undertaken.
● Outstanding organizational skills.
Join our team as a Regulatory Affairs Specialist where you will play a vital role in ensuring compliance with regulatory standards while contributing to the success of our organization. We offer a competitive salary, benefits package, and opportunities for professional growth.
Apply now to be part of our dynamic team!
Job Type: Full-time
Pay: £26,000.00-£30,000.00 per year
Additional pay:

• Performance bonus

Benefits:

• Company pension
• Free parking
• Health & wellbeing programme
• On-site parking
• Sick pay

Schedule:

• Monday to Friday

Experience:

• Regulatory Affairs: 1 year (required)

Work authorisation:

• United Kingdom (required)

Work Location: In person