Regulatory Affairs Manager I_CO

TalentBurst•Indianapolis, IN

2d•Hybrid

About The Position

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.

Requirements

3-5 years experience with PhD degree, 5-7 with Masters 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.

Nice To Haves

Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.

Responsibilities

Oversees 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.
Effectively partner with stakeholders to understand and provide best solutions.
Takes initiative to address problems or opportunities and involves stakeholders for best solutions.
Develops external relationships that significantly influence the current and future direction for Roche and our products.
Contributes to audits preparation and is potentially active in audit discussions.
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 world wide approvals.
Effectively partners with stakeholders to understand and provide best solutions.
Takes initiative address problems or opportunities and involves stakeholders for best solutions.
Develops relationships that significantly influence the current and future direction for Roche 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.
Has courage to make decisions even outside of scope/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.
Commits 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.
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.
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 ambassador for their environment.
Actively develops their agile mindsets and behaviours 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.
Is able to pull people together around a common goal.
Seeks to understand and build on different perspectives to enhance outcomes.
Addresses and resolves 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.
Speaks up and actively participate.
Creates an environment of recognition and appreciation.
Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.