International Regulatory Manager, Regulatory Affairs
- Experience Level
- Experienced (non-manager)
We are an innovative, curious and diverse company with over 90'000 professionals in 150 countries. As a global leader in research-focused healthcare, we are constantly learning and growing - and are therefore seeking people who share the same ambitious vision.
We support our staff in the development of their knowledge and skills. Further local and global career opportunities are offered to people who demonstrate talent and aptitude.
We currently have an opportunity for an International Regulatory Manager to join our growing Global Product Development Regulatory team in Welwyn, UK.
Key Responsibilities and Tasks
Within the International Regulatory Team, you work on regulatory activities for markets under your responsibility and actively contribute to the development and implementation of regulatory strategies for assigned products across affiliates. You belong to the global product team and you are the primary contact for affiliates to develop and execute regulatory and policy strategies. More precisely you:
- Provide expert knowledge on regulatory requirements and environment for assigned countries. You collaborate closely with global teams to ensure clinical development requirements in International/assigned countries are integrated into the global development plans. You are a strong partner to affiliates, you ensure their voice is represented within headquarters and enable them to find innovative solutions
- Are a key member of the RAFT (Regulatory Affairs Functional Team) partnering with the GRL (Global Regulatory Leader) and EU and US Partners to discuss and align on regulatory tasks
- Work in close collaboration with the affiliate DRA's, Labelling managers, Clinical Trial Regulatory Management and International Technical Partners to build regulatory and policy strategies, secure endorsement and ensure timely and innovative submission of regulatory applications
- Are key in our interaction with Health Authorities. You lead the planning of meetings with Authorities, respond to their questions and provide authoring support as needed. You influence health authorities to advance the regulatory standard in your assigned markets
- In collaboration with our colleagues in Pharma Technical Regulatory and Policy, develop and execute objectives and policy plans towards aligning one global regulatory standard in international markets
- Contribute to projects and initiatives inside and outside of the core scope of an International Regulatory Manager.
Who are we looking for?
We are looking for an experienced regulatory professional bringing:
- Strategic and Innovative Thinking: You apply regulatory and scientific knowledge to determine solutions and solve complex problems. You are able to develop clear, effective and creative regulatory strategies to support goals.
- Technical Competence: You have a deep knowledge of the scientific and regulatory current environment, experience of global regulatory processes and in dealing with Health Authorities.. You hold a University Degree, preferably in a scientific field and a minimum of 7 years of experience in Regulatory Affairs
- Leadership: You autonomously lead projects, take initiative to solve issues, provide strategic input, set milestones, allocate responsibility, monitor the progress towards results and work according to performance measures time, cost and quality
- Teamwork: You work effectively to share responsibility as a team member
- Communication and Negotiation Skills: You can influence individuals or groups on more than one level who may have different interests or goals to achieve team objectives
- Fluency in English
- Ability to travel occasionally
If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you. Every role at Roche plays a part in making a difference to patients' lives. If you want to work in a passionate team, make your mark & improve lives, apply now.
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.