We are currently looking for a Regulatory Affairs Specialist to join a leading Distribution company based in the Kent area.
As the Regulatory Affairs Specialist you will be responsible for maintaining the integrity and compliance of medicinal product imports, ensuring the highest standards are met in line with industry regulations.
This will be a hybrid role consisting of 3 days on site and 2 days working from home.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Specialist will be varied however the key duties and responsibilities are as follows:
1.
Meticulously prepare and submit regulatory filings and documentation to the MHRA, ensuring all parallel import requirements are met.
2.
Proactively monitor and interpret regulatory requirements, communicating essential variations to key stakeholders and submitting these in a timely manner.
3.
Collaborate with cross-functional teams, including Quality Assurance, to strategise and align regulatory submission processes.
4.
Manage packaging components stock levels, maintaining a balance between compliance and operational efficiency.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Regulatory Affairs Specialist we are looking to identify the following on your profile and past history:
1.
A relevant degree in a scientific or related field.
2.
Proven experience in Regulatory Affairs, specifically within parallel imports of medicines.
3.
A thorough understanding and practical experience with quality assurance principles.
4.
Exceptional written and verbal communication skills, paired with an independent and collaborative work ethic.
Key Words: Regulatory Affairs | MHRA | Parallel Imports | Quality Assurance | Compliance | Pharmaceutical Regulations | Medicinal Products | Regulatory Filings | Regulatory Submissions | Regulatory Strategy |