Regulatory Affairs Manager I

Job Description

Job Summary:

• The position holder ensures that Products for the respective area of responsibility shall obtain Regulatory approvals in defined markets in close cooperation with other functions.
• The documents/deliverables for submissions are coordinated and compiled in a timely manner to support planned product registration timelines.
• The obtained Regulatory approvals/licenses products are maintained throughout the life cycle of the product by applying successful Regulatory change controls.
• The efficiency and the success of the Regulatory activities and strategies are maintained by clear agreements with other functions, stakeholders and external partners (authorities, companies, NBs etc.).
• The regulatory requirements and strategic aspects are understood, communicated and implemented, kept up to date and are transparent within the organization.
• The activities are driven by a mindset of innovation, agility and the principles of VACC leadership.
• Regulatory document and submission compilation:
• Oversee the development of submission/product registration dossiers of more complex products/programs.
• Develops and manages at least parts of comprehensive global regulatory submissions and registration plans.
• May act as mentor for more junior team members in this area.

External interface management:

• Effectively partner with stakeholders to understand and provide best solutions.
• Takes initiative addressing problems or opportunities and involves stakeholders for best solutions.
• Develops external relationships that significantly influence the current and future direction for Client’s and our products.
• Contributes to audits preparation and is potentially active in audit discussions.

Regulatory knowledge and strategy:

• Leads the organization to adapt to the evolving regulatory environment and requirements.
• Experience in solving complex, critical health authority issues or equivalent.
• Understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making.
• Ability to interpret and apply understanding of the regulators’ thinking to projects and apply strategies to the different needs of different regions without significant guidance.
• Proactively creates unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.

Stakeholder management and influencing:

• Effectively partners with stakeholders to understand and provide best solutions.
• Takes initiative addressing problems or opportunities and involves stakeholders for best solutions.
• Develop relationships that significantly influence the current and future direction for Client’s and our products.
• Understands what motivates other people to perform at their best.
• Is skilled at managing and influencing peers.
• Fosters an exchange of ideas amongst key stakeholders to be able to shift perspectives to reach a common agreeable outcome.
• Negotiates with stakeholders and creates win-win compromises.

Decision making:

• Has courage to make decisions even outside of Product/comfort zone.
• Proactively Initiates activities independently and initiates interactions across departments as applicable.
• Embrace the good decision-making principles.
• Pushes decision making to the lowest appropriate level.
• Commitments to decisions that have been made.
• Shows good judgment in decision making.
• Makes good decisions without necessarily having all the information in a timely manner.

Innovation and problem solving:

• Drives innovation across the organization/sites.
• Advocates for and helps progress new ideas that add business value.
• Sees the value in others’ unique differences.
• Is entrepreneurial; seizes new opportunities.
• Works to drive new ideas into the business.
• Able to troubleshoot issues as they arise, independently develop and implement cost effective and non-complex actions solutions to ensure that daily work is completed without jeopardizing compliance.
• Identifies problems before they occur and actively drives mitigation strategies to avoid them.
• Leads others in problem-solving activities.

VAAC Leadership and agility:

• Starts to live the spirit of we all lead. Identifies opportunities to develop VACC competency.
• Acts with integrity, courage, passion and honors commitments.
• Contributes an inclusive environment which supports all dimensions of diversity.
• Explores the opportunity of leadership and future contribution.
• Takes initiative when opportunities arise.
• Change ambassadors for their environment.
• Actively develops their agile mindsets and behaviors and encourages others to do so as well.
• Identifies and acts on opportunities for improvement within across Q&R.
• Embraces new technologies and other means to simplify and increase productivity.
• Owns their regulatory data and promotes data stewardship within their RA teams and uses and promotes the usage of all regulatory tools.
• Contributes to or leads projects with an understanding of how business functions, systems, processes, and data management are connected and essential to achieving digitalization and strategic goals.
• As RA manager it is our expectation that you start to mentor more junior regulatory employees and actively share your knowledge across the organization.

Teamwork and communication:

• Is able to pull people together around a common goal.
• Seeks to understand and build different perspectives to enhance outcomes.
• Addresses and resolve conflict by creating an atmosphere of openness and trust.
• Brings out the best in people and teams.
• Makes people feel that they are truly heard.
• Expresses complex ideas fluently and clearly.
• Encourages direct and open discussions about important issues.
• Can be depended on to tell the truth regardless of the circumstances.
• Recognizes and reflects/articulates multiple points of view on an issue.
• Provides honest input even in difficult situations.
• Speak up and actively participate.
• Create an environment of recognition and appreciation.

Requirements:

• Demonstrated experience and knowledge of DailyManagement and Continuous Improvement best practices.
• 3-5 years’ experience with PhD degree, 5-7 with master’s degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
• Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.
• Has demonstrated the ability to manage high complexity work and/or at least parts of global projects.
• Specialist knowledge.