US_Regulatory Affairs Manager I_CO

PR: *** (Please do not disclose pay rate on recruting sites)
Max Bill Rate ***
OnSite Position
Indianapolis Indiana Campus
1st Shift Hours
Hybrid Schedule - 2 Days Remote/ 3 Days Onsite
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:
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.
External interface management:
Effectively partner with stakeholders to understand and provide best solutions. Takes initiative t
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.
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 world wide approvals.
Stakeholder management and influencing:
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.
Decision making:
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.
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 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.
Teamwork and communication:
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.
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.
Specialist knowledge

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.