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The PositionTo plan, in alignment with the applicable stakeholders, control and eventually execute all the sanitary regulatory activities needed to guarantee the affiliate’s license to operate in the CA&C region. To support definition and execution of the Regulatory Policy strategy on the CA&C region. Co-lead the development of team members within their specific team.
The Opportunity:
To monitor and actively participate in the sanitary legal and regulatory environment within the countries of the region assigned under her/his responsibility. This includes, but is not limited to new regulations, changes on current ones or implementations of past regulations.
Define and support his/her team on the definition of a yearly based regulatory plan including all the regulatory activities needed for each country to achieve the business goals established. This includes but is not limited to license renewals, product changes, modifications and new product approvals.
Define the co-creation spaces where the regulatory plan will be aligned with the respective stakeholders.
Support the Regulatory Affairs Manager in the decision making process and control the execution of regulatory activities designated to External RA Agencies.
Maintain and control of regulatory databases, guaranteeing that the information needed by local, regional or global stakeholders is up to date.
Compile and submit all the legal and technical documents needed for the registration process in his/her country, in compliance with the local regulation requirements. This includes the management of translations with the defined supplier and/or the request of documents to the global regulatory support teams.
Coordinate the payment activities needed for each registration dossier under his/her responsibility.
Follow up with the regulatory authorities of sanitary registration processes and resolution of observations whenever it’s required.
To identify and define the respective action plans to guarantee the continuous process simplification and improvement within the Regulatory Unit.
To act as the people leader of the staff under her/his responsibility, providing direction, support, and development in alignment with corporate guidelines and leadership principles.
Foster the professional development of team members through regular feedback, coaching, and growth opportunities aligned with individual and organizational goals.
Act as a VACC Leader.
To collaborate closely with the Regulatory Affairs Manager in any projects or activities required at a local, regional or global level.
Who you are:
University degree in Healthcare sciences or related field.
Demonstrate similar experience in regulatory positions in a multinational company environment (ideally in the pharmaceutical, medical devices or IVD industry).
Organized, proactive and organized.
Excellent customer focus and planning skills.
Adaptable to work on teams and alone in an efficient manner.
Excellent communication skills and confidentiality.
Clear sense of accountability on the tasks and responsibilities assigned.
Fluent in English and Spanish is indispensable.
Knowledge and experience in Agile Methodologies is a plus.
The position reports to the Regulatory Affairs Manager based in Panamá.
Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
Top Skills
Roche Pune, Mahārāshtra, IND Office
671-75 Ganeshkhind Road, Pune, Maharashtra, India, 411005
