Regulatory Affairs Coordinator

Job description

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

Your role:

Responsible for ensuring the Company's compliance with regulations and laws applicable to the Life Science business of the Company, protecting the company from liability. Additionally, provides expertise on Regulatory and/or Trade Compliance topics.

Provides expert advice to ensure proper evaluation of regulations applicable to products and services provided or under development for the Company LS. Plans and manages Regulatory and Trade Compliance activities on both new and in-line products in accordance with applicable regulations. Stays informed on regulatory trends and publications. Maintains relationships with local authorities and industry associations relevant to the Life Science business of the Company and trains local teams in Regulatory and Trade Compliance topics.

 

Main responsibilities

Regulatory & Trade Compliance assessments and inquiries:

·  Executes regulatory assessment of both new and in-line products to identify applicable requirements from relevant authorities
·  Executes investigation and response for regulatory inquiries, as assigned by Supervisor

Product registration:

·  Executes regulatory activities to establish and maintain product compliance with requirements from relevant authorities, including product registrations. Responsible for:
·  Supporting the development of a submission strategy
·  Requesting from headquarters or manufacturing sites, as applicable, all documents and/or dossiers necessary for submission to the responsible authority, in accordance to established internal procedures
·  Preparing the files and/or dossiers for submission according to the legal timeframes and within agreed deadlines
·  Submitting documents as approved and requested by the supervisor
·  Monitoring submissions and keeping supervisor informed about submission date, upcoming questions and final decisions from the authority
·  Updating records related to the submission in RIMS as applicable and in accordance to established internal procedures
·  Verifying that all product registrations comply with the local legislations applicable and inform supervisor in case of any findings

Site registration

·  Executes regulatory activities to establish and maintain site compliance with requirements from relevant authorities. Responsible for:
·  Supporting the development of a submission strategy
·  Requesting from the sites, as applicable, all documents necessary for submission to the responsible authority, in accordance to established internal procedures
·  Preparing the files for submission according to the legal timeframes and within agreed deadlines
·  Submitting documents as approved and requested by the supervisor
·  Monitoring submissions and keeping supervisor informed about submission date, upcoming questions and final decisions from the authority
·  Updating records related to the submission in RIMS as applicable and in accordance to established internal procedures
·  Verifying that all site registrations comply with the local legislations applicable and inform supervisor in case of any findings

Product import/export:

·  Executes regulatory activities related to compliance with customs requirements from relevant authorities. Responsible for:
·  Supporting the development of a submission strategy, if applicable
·  Gathering data to prepare statements to the responsible authorities, when necessary
·  Preparing documents, collecting signatures and arranging the submission
·  Monitoring submissions and keeping supervisor informed about submission date, upcoming questions and final decisions from the authority

Technovigilance:

·  Defining procedures to allow the identification of reports that are significant for technovigilance
·  Gathering data to prepare reports to the responsible authorities, as necessary
·  Preparing documents, collecting signatures/approvals and arranging the submission
·  Keeping supervisor informed about submission date and any issues faced
·  Archiving reports and other legal documentation or other records in accordance with internal procedures
·  Auditing the processes periodically to verify compliance.

Surveillance of new and changed regulations: 

·  Executes the monitoring of new or changed legislations that impacts the business of the Company Life Science and communicate stakeholders in the organization accordingly
·  Keeps records of changes in accordance to established procedures
·  Monitors surveillance records to guarantee accuracy and to identify relevant records that should be communicated to supervisor.

Interactions with authorities & Advocacy: 

·  Interacts with local Governmental officials and Associations and Groups as required for the development of daily tasks or as assigned by Supervisor
·  Keeps records of interactions and agreements with authorities, in accordance to established procedures
·  Keeps records of interactions and agreements with authorities, reported by local regulatory consultants that interact with authorities on the Company's behalf as applicable
·  During inspections from authorities, may be part of the committee that will interact with the inspectors, as assigned by the supervisor. 

QM: 

·  Executes the identification of regulatory requirements applicable to the company's Quality Management System. Helps communicate them to the organization and oversee implementation, as assigned by Supervisor.

Promotional materials: 

·  Executes the revision of promotional materials in accordance with written procedures and as assigned by Supervisor.

Risk management: 

·  Executes the Risk Management program by identifying and reporting risks to the supervisor
·  Executes the root-cause investigation for risks identified and the implementation of mitigation plans, as assigned by supervisor.

Compliance: 

·  Complies with the rules set forth by the Company Code of Conduct, Corporate LS Standards and regional/local procedures.

Governance

·  Executes projects assigned by the supervisor and in accordance to established deadlines and performance standards
·  Implements standards to ensure regulatory compliance, avoiding business disruptions related to compliance issues
·  Supports in the selection and oversight of external vendors, as requested by supervisor.

 

Who you are?

·  Degree in a Life Science or related discipline, such as pharmacy or chemistry, Master desirable
·  Requires a graduate background plus some to substantial relevant professional experience, and good knowledge and experience in own discipline and beyon
·  Good experience in evaluating regulatory documentations and managing regulatory submissions through to approval
·  Ability to support the development and management regulatory strategies
·  Working knowledge of applicable International regulatory standards
·  Working knowledge of local regulatory requirements
·  Adequate ability to recognize business needs, think strategically and develop risk mitigation strategies
·  Fluent English and local language communication skills (oral and written)
·  Ability to effectively share information and any proposals with management, peers and others
·  Experience with Authority Interactions and negotiations, as well as with advocacy in
·  Structured approach to working tasks and problem solving
·  Able to manage projects independently in time constrained situations
·  Ability to work independently and successfully within a multidisciplinary and multicultural team environment
·  Business–orientated thinking

 

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Job Requisition ID:  257616

Location:  Carlos Spegazzini

Career Level:  D - Professional (4-9 years)

Working time model:  full-time .buttontext3e34be14e841299e a{ border: 1px solid transparent; } .buttontext3e34be14e841299e a:focus{ border: 1px dashed #eb3c96 !important; outline: none !important; }

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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