Sr. Associate - Regulatory Affairs - Operations
Inviting applications for the role of Jr Manager, Regulatory Affairs for Translation management, artwork review and change management.
Responsibilities
In this role, you will be responsible for:
•Ensure that changes required through DCIs are properly implemented in the SCF and that there are no differences against the approved artwork.
•Ensure that the changes in SCF are related to LRAM's DCI request, additional changes received in SCF comply with the regulation.
•In multi-country presentation, evaluate the impact of the changes to the countries involved. If applicable, align alternative solutions with the LRAMs of the affected countries.
•Develop the implementation plan together with the LCM.
•Utilization of software and systems like SAP, Veeva Vault, TVT
•Backup for the translation management activities
•Translation management activities for LATAM countries
•Coordination of dossier translation including retrieving and processing editable documents for translation
•Coordination of translation for maintenance events, renewals, CMC, CCDS
•Technical validation of received documentation and translated documents (including formatting, excluding subject matter/content check)
•Maintain traceability trackers
Minimum Qualifications
•A minimum of 3 years of experience in regulatory affairs with knowledge of current guidelines in the LATAM market.
•Bachelor's degree, preferably in Pharmacy, Medicine, Chemistry, or related Life Science discipline, with relevant experience in the pharmaceutical industry.
•Mandatory knowledge of regulations for the LATAM market.
•Advanced level in English language.
Preferred Qualifications / Skills
•Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.
•Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.
•Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviours to drive high quality deliverables.
•Demonstrates the ability to independently solve/troubleshoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions.
•Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
•Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.
•Depending on experience level, mentor newly hired staff or lead a team of junior staff.
•Flexibility in responding to changing priorities or dealing with unexpected events.
•Capability to handle multiple priorities and balance work to achieve business goals.
Qualifications
Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs
Certifications
Certified Compliance Officer (CCO) - Vskills, Certified Regulatory and Compliance Professional (CRCP) - JSS University, Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)
Required Skills
Personal Effectiveness
Language
English (Required)
Job Details
•Job Type: Regular
•Master Skill List: Regulatory Affairs - Operations
•Remote Type: Remote
•Work Shift: Day Job (Costa Rica)
