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The Opportunity:
We are seeking a highly skilled and experienced Regulatory Affairs Manager to join our team. The successful candidate will be responsible for ensuring that our products comply with all relevant regulations and standards. This role involves managing regulatory submissions, maintaining compliance with regulatory requirements, and liaising with clients and regulators.
Key Accountabilities
- Develop and implement regulatory strategies to ensure compliance with local, regional, and international regulations.
- Prepare and maintain regulatory documentation for Reacta’s product portfolio.
- Monitor and interpret regulatory requirements and communicate changes to relevant departments.
- Provide regulatory guidance and support to cross-functional teams, including R&D, quality assurance, and marketing.
- Manage interactions with clients regarding their regulatory submissions.
- Represent the company in regulatory meetings and inspections.
- Maintain regulatory files and documentation in accordance with company policies and regulatory requirements.
- Ensure timely and accurate reporting of regulatory activities and status updates to the business.
- Conduct regulatory risk assessments and develop mitigation strategies.
- Stay current with industry trends and regulatory developments to ensure ongoing compliance.
Skills, Qualifications and Experience
Essential
To be successful in this role, applicants need to have the following essential skills and experience:
- Bachelor's degree in a scientific or related field.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of regulatory requirements and guidelines, including FDA, EMA, and other relevant regulatory bodies.
- Strong project management skills with the ability to manage multiple projects simultaneously.
- Excellent written and verbal communication skills.
- Detail-oriented with strong analytical and problem-solving abilities.
- Ability to work independently and as part of a team.
- Proficiency in regulatory submission software and tools.
Desirable
- Experience with regulatory submissions for new product approvals and post-market changes.
- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
- Familiarity with electronic submission processes and requirements.
Do you want to feel inspired every day? We are future-focused, and our business is growing rapidly. We succeed together through passion, commitment, and teamwork, and so can you.
