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Director Regularity Affairs
Continued innovation within the Life Sciences industry is resulting in new and improved variations of medical and healthcare products. Helping to ensure these products meet the legislative requirements needed for commercialisation is the role of a Director of Regulatory Affairs. At Meet, we understand how crucial Regulatory Affairs Directors are to companies and the wider population.
A Director of Regulatory Affairs is the vital link between the pharmaceutical company, the products it develops and the regulatory authorities. They oversee the necessary licensing, marketing, and compliance for the medical products before they reach the market.
Throughout the development of a product, a Director of Regulatory Affairs creates and leads a team through a regulatory strategy. In addition, due to the seniority of the role, they will be tasked with more complex regulatory assignments of different scales.
Below is a list of some of the products a Director of Regulatory Affairs will work on:
- pharmaceuticals
- veterinary medicines
- complementary medicines
- agrochemicals
- pesticides
- therapeutic devices
- diagnostic devices
- cosmetics
Individuals within this role are commercially driven, combining their science, legal, and business expertise. A Director of Regulatory Affairs is passionate about making a difference, transforming businesses, and improving patients' lives. Ultimately, it is a highly regarded position sought after by clients and candidates alike.
Responsibilities of a Director of Regulatory Affairs
Depending on the employer, a Director of Regulatory Affairs is responsible for the following:
- Developing and implementing regulatory strategies.
- Work with unlicensed medicines and EAP products.
- Leading client phasing interactions and contributing to the company’s business development growth.
- Collaboration with Contract Research Organisations (CROs) and stakeholders.
- Ensure a company's products are regulatory compliant with the regions where distribution is intended
- Collate and analyse data specific to the project
- Compile clear arguments and explanations for new and developing product licences and licence renewals
- Prepare licence variations and renewal submissions to strict deadlines
- Monitor and set timelines for licences and renewals
- Write clear product labels and patient information leaflets
- Develop product trials and interpret the data from the trials
- Provide advice to scientists and manufacturers on the latest regulatory requirements
- Give strategic advice to senior management throughout the development and implementation of a new or existing product
- Project managing teams involved in the development and implementation of new and current products
- Manage and carry out regulatory inspections
- Review company practices and provide recommendations on changes to systems and processes
- Liaise and present to regulatory authorities
- Negotiate with regulatory authorities for marketing authorisation
- Support in the development of marketing concepts and approve packaging and advertising before a product is launched
Skills and experience needed
Talent best suited to the Director of Regulatory Affairs role will be required to have the below skills and experience:
- Expert knowledge of legal and scientific subject matters
- Thorough understanding of drug development
- Analytical and problem-solving skills
- Excellent written and verbal communication skills
- Great attention to detail
- Strong negotiation skills
- Efficient IT skills, specifically relating to databases and commercial software
- Ability to work under pressure and to strict deadlines
- Confidence to report and communicate to management
- Teamwork and leadership skills
- Project-management skills
- Work to high standards with a professional approach to work
- Extensive regulatory experience within the biopharmaceutical industry or health authority experience
- Experience managing complex regulatory deliverables across projects/products
Qualifications
Any Director of Regulatory Affairs will be expected to have the below qualifications:
A BS/MS degree or postgraduate qualification in Life Sciences, biological science pharmacy, or other health-related discipline is preferred. This could include:
- Biochemistry
- Biology
- Biomedical engineering
- Biomedical science
- Biotechnology
- Chemical and physical sciences
- Chemistry
- Engineering
- Medicine
- Pharmacology
- Pharmacy.
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At Meet, we champion the people who work in Life Sciences. We share the purpose of the innovative companies within the sector and create the teams driving the future of global health. Our philosophy echoes this; to provide exceptional, personalised service.
Since our founding year over ten years ago, Life Sciences has always been our passion and focus. Whether you're a client or candidate, our team of expert professionals can take your business or career to the next level.
Meet is not your traditional recruitment leader. We make it our mission to secure the best talent who can make a difference to the planet and your business. So, if you're looking to hire your next Director of Regulatory Affairs, partner with us. Discover how we can help source your ideal candidate today.
If you're looking for your next opportunity within Pharma and Biotech as a Director of Regulatory Affairs, our professionals can help. We can present you with part-time and full-time permanent roles, all with the most competitive salaries. Find your future position with Meet today. Learn more here.