My client is a biotech company specialising in regenerative medicine as well as actively pursuing clinical programs in wound healing, cardiovascular diseases, and women’s health. They have created a fun and collaborative environment and due to their success, they are growing at an exciting rate! They are seeking a Director/Senior Director, Regulatory Affairs to join them in nurturing and growing the business. This is a full time permanent remote position.
The role
The Director/Senior Director of Regulatory Affairs will direct the preparation and submission of regulatory agency applications, reports, or correspondence and will report to the Senior Vice President of Regulatory Affairs at the company.
Main Responsibilities
- Establish and manage the development and/or review of key documents, including abstracts, presentations, protocols and write reports and regulatory documents for IND, BLA submissions
- Involvement in preparing pre-IND, Fast Track, Breakthrough or RMAT designation submissions
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Manage activities such as audits and regulatory agency inspections
- Provide responses to regulatory agencies regarding product information or issues
- Maintain current knowledge of relevant regulations, including proposed and final rules
- Maintain regulatory or compliance documentation
- Examine marketing materials to ensure compliance with policies or regulations
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards
- Establish regulatory priorities or budgets and allocate resources and workloads
- Establish and develop relationships with key opinion leaders
Requirements
- One of the following combinations of education and experience is required:
- A minimum of a bachelor’s degree plus 6 years of health regulated industry experience
- A master level degree plus 4 years of health regulated industry experience
- A PharmD/PhD with 2 years health regulated industry
- A degree in a scientific discipline is preferred
- Strong knowledge of the drug development process and regulatory submission and approval process is required
- Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required
- Experience responding to FDA requests and managing FDA interactions is required
- Experience lifecycle management of IND/NDA applications is required
- Demonstrated experience in critically reviewing and compiling regulatory documents is required
- Diverse therapeutic area experience is a plus
- A proven ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization is required
- The ability to effectively prioritize assignments for multiple products and projects simultaneously is required
- Strong interpersonal and communication skills
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything