Senior Manager/Director of Regulatory Affairs
8 hours ago
Company Overview: As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products. To support our expanding international operations, we are looking to hire a skilled Regulatory Manager to oversee our regulatory affairs and ensure compliance in the United Kingdom.
We are seeking a knowledgeable and experienced Regulatory Manager for our operations in the United Kingdom. The successful candidate will be responsible for managing regulatory submissions, ensuring compliance with UK regulations, and collaborating with internal teams to secure product approvals and maintain compliance in the UK market.
Lead all regulatory activities in the United Kingdom, ensuring compliance with MHRA (Medicines and Healthcare products Regulatory Agency) and other relevant authorities.
Prepare and manage regulatory submissions, including product registrations, renewals, and variations for pharmaceutical products in the UK.
Keep up to date with regulatory changes in the UK and ensure that Medisal Pharma is compliant with local and European regulations (where applicable).
Serve as the primary point of contact between Medisal Pharma and the UK regulatory authorities.
Provide strategic regulatory advice to support product development, labeling, advertising, and market access.
Manage regulatory audits and inspections, ensuring that all processes are compliant with UK legal requirements.
Collaborate with internal teams (R&D, QA, production) to support regulatory submissions and maintain product compliance.
Ensure post-marketing surveillance activities are conducted and product safety monitoring requirements are met.
Contribute to strategic planning and risk assessment for regulatory pathways and submissions in the UK.
Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field (advanced degree preferred).
Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry, specifically in the United Kingdom.
Comprehensive knowledge of MHRA regulations and UK pharmaceutical legislation.
Strong communication skills with the ability to manage relationships with regulatory authorities and internal stakeholders.
Detail-oriented with excellent project management and organizational skills.
Fluency in English is required.
Competitive salary based on experience and qualifications.
Opportunities for career progression and professional development.
Health insurance, paid time off, and other standard benefits.
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