Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Regulatory Affairs Manager – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
To further strengthen our Project Management team, we are looking for a talented CMC Project Manager. This position will occupy a key role supporting Chemistry, Manufacturing and Controls (CMC) development for our therapeutic antibodies, ensuring that projects successfully move forward within and across functions. You will perform planning, controlling, monitoring and reporting for assigned project in collaboration with the CMC Leads and the project teams. This includes CMC activities like process development, analytical development, product development, technical transfer, dossier development, clinical manufacturing and project strategy. The ideal candidate will be detail driven and have a proven track record driving project success within CMC in the pharma/biotech industry.
As part of our global team, you’ll have the opportunity to provide technical and project leadership over a client Project. As a Regulatory Affairs Manager, you'll offer innovative solutions, including regulatory affairs expertise and client interface, to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization. You will provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements. Additionally, you will act as a liaison with internal and external clients in the provision and marketing of these services.
What You’ll Do:
- Responsible for achieving project goals, including timelines, budget, and scope.
- Translate the scientific strategy into a CMC project plan with support of the CMC leads for one or more drug development programs/projects, visualising timelines and dependencies between deliverables and define budget needs
- Track, monitor and report key milestones and decision points to drive delivery of projects in accordance with corporate objectives., balancing scope, cost, timelines and risk;
- Build strong working relationships with internal and external key stakeholders to ensure timely completion of CMC activities by continuously monitoring progress;
- Perform critical path analysis and risks, taking into account cross-functional interdependencies in the overall development project plan;
- Coordinate on the delivery of those critical path items through prioritization setting where required and mitigate or escalate the risk together with the project team;
- Perform scenario simulations and advise on optimum development planning, as needed;
- Prepares and leads project team meetings including issuance of agenda, actions and meeting minutes to be documented, communicated and committed.
- Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.
• Provides senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.
• Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects ofmoderate to high complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Ensures quality performance for key/managed projects.
• Manages project budgeting/forecasting functions.
• Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
• Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments.
• Provides matrix/project leadership, training and guidance to junior team members.
• Ensures compliance with relevant organizational and regulatory SOPs and WPDs.
• Participates in launch meetings, review meetings and project team meetings
Education and Experience Requirements: - Master degree in life-sciences;
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 9+ years). At minimum 5 years CMC project experience;
- Experience in working with biologics is a plus;
- Excellent planning and organizational skills, able to multi-task in a multicultural environment and prioritize,
- Strong analytical, problem solving and critical thinking skills with action-oriented follow through
- Experience working with CMC Teams and managing relationships with CMC vendors is strongly preferred and capable of building effective relationships
- Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines;
- Quality conscious attitude;
- Demonstrated project management skills, responsiveness to issues, and passion for contributing to the development of new medicines
- Excellent communication skills
- A self-starter with the ability to work in a fast-paced environment and adapt quickly to changing needs and priorities;
- Fluent in English;
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Excellent English language (written and oral) communication skills as well as local language where applicable
• Excellent attention to detail and quality as well as excellent editorial/proofreading skills
• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Excellent negotiation skills
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
• Superb understanding of medical terminology, statistical concepts, and guidelines
• Excellent analytical, investigative and problem-solving skills
• Excellent understanding of budgeting and forecasting
Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.