My client is a global CRO company who is based in over 100 countries! This company advances in data sciences, technology, and healthcare expertise to help sponsors and medical devices gain a deeper understanding on how to treat disease. They are currently seeking an Associate Director, Regulatory Affairs based in Massachusetts to join their dynamic team! This is a full time permanent hybrid position.
Responsible for the development of regulatory business, in accordance with Regulatory Affairs business plans. Participates in project-related work, as necessary. Line Management responsibilities for a team of Regulatory staff.
Essential Functions
- May manage staff in accordance with organization’s policies and applicable regulations; handles personnel issues, conflict management, defines goals that increase knowledge and skills of staff, and defines staff expectations, without involvement of senior managers;
- May assist in the coordination of projects and resources, ensuring quality deliverables to customers;
- May undertake risk analysis and manages the outcome as appropriate;
- Builds strong relationships with managers of other operations and acts as a positive ambassador for Regulatory Affairs;
- May act as a Project Manager for a large stand-alone programme, involving several regulatory or technical deliverables and/or region, and/or operation; May provide strategic regulatory and/or technical consultancy on a variety of projects;
- May manage meetings with Regulatory Agencies;
- May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients;
- May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications;
- Responsible for leading moderate to significant improvements of processes, systems or products to enhance performance of job area;
- May be assigned as Reviewer and/or Approver for Regulatory standard operating procedures or cross-functional standard operating procedures owned by other operations;
- May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative;
- Performs other duties, as business needs require;
Qualifications
- Bachelor's Degree in Lifesciences or related discipline Required
- Master's Degree in Lifesciences or related discipline Preferred
- At least 6 years regulatory experience including 3 years management experience (or a combination of education, training and experience)
- Possesses a specific regulatory or technical expertise;
- Good, solid interpersonal communication (oral and written) and organization skills;
- Strong software and computer skills, including Microsoft Office applications;
- Demonstrates negotiation skills and is confident in making decisions with minimal supervision;
- Ability to work on several projects, retaining quality and timelines;
- Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for guidance of staff
- Sets a positive example to staff, relating to professionalism, attitude and interaction with colleagues and customers;
- Ability to manage competing priorities, as appropriate;
- Possess practical knowledge in leading and managing the execution of processes, projects and tactics within one department or multiple related departments;
- Ability to exercise independent judgement taking calculated risks when making decisions;
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
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