We are currently looking for a talented Regulatory Manager. The successful candidate must have proven experience in regulatory strategy and submissions. The candidate must have good understanding of the regulatory requirements allowing successful registration with the authorities and the product development process. Given that most of the new developments are targeted for the USA, experience with FDA requirements and strong experience with CMC, is a must.
The job description
As Regulatory Manager you will:
• Represent Regulatory Affairs on product development project teams to ensure all regulatory requirements are met throughout the drug development process.
• Advice on regulatory CMC/Clinical strategy in collaboration with the Clinical Affairs, R&D, and Business Development departments
• Ensuring that Regulatory activities meet the internally agreed timelines and manage delays, for clinical studies (IND) and ANDA/NDA approvals
• Review data, protocols and reports.
Your professional profile
• Strong educational background (MSc or higher in life science)
• At least 10 years’ experience the pharmaceutical industry, and in similar function
• Strong interpersonal skills with the ability to influence others in a positive and effective manner,
• Demonstrated ability to contribute to a continuous learning and process improvement environment,
• Ability to understand and analyze scientific data and results and review scientific documents including drug development reports, publications and regulatory submissions.
• Strategic thinking, strong problem-solving and analytical skills
• Understanding the scientific principles and regulatory requirements
• Communication and motivation skills,
• Detailed oriented
• Strong sense of planning and prioritization
• Good understanding of and respect for cultural differences and the capacity to work effectively in a multicultural environment
• Fluent English, both written and oral
ABOUT OUR COMPANY
Hyloris is a virtual company focusing on launching added-value products in the US. The headquarter is in Liege, Belgium, but we have people based in the US also.
Hyloris has a robust management team with a success track record from many years in the pharmaceutical industry. We have a full operational structure with departments for Business Development, R&D, Regulatory, Medical Affairs and Licensing. Operations are currently outsourced.
Our talented staff work in accordance with our company values:
• We are proud of our entrepreneurial culture and foster open communication, mutual respect, professionalism and efficient decision-making and we believe that our multicultural organisation is one of our most important competitive advantages.
• We believe that timely and well considered decisions as a response to emerging opportunities and ideas is the key to our success.
• We believe that the success of the company lies in the competence, dedication and motivation of each of our employees.
• We believe that freedom returns flexibility and empowerment returns commitment.
ABOUT OUR R&D DEPARTMENT
We work on an exciting pipeline of more than 15 value added products and are focused on adding more projects to our pipeline, so we are heavily expanding the team. We are working with regulatory CROs World-wide.