Login or register for free to apply for this job

Category

---

General Administrative

Description

---

Job Description – Submission Management - BOGOTA,COLOMBIAResponsible for the review and finalization of Global Regulatory Strategy Documents, CTD sections for delivering dossier that meets the individual national content and technical (such as but not limited to eCTD, NeES and Paper) requirements for which the submission is targeted (Asia Pacific, Australia/New Zealand, Africa - Middle East, Europe, East Europe, Latin America and United States)Responsible for effective coordination with the cross functional teams, site and Global RA teams for authoring, review and finalization of dossiers for the pipeline products to ensure effective data presentation and quality.Proactively enters and maintains critical regulatory information relating to assigned submissions within required systems and to required standards and timelines.Monitor and set timelines for filling MA transfer, variations, license renewals, product amendments/supplements and other product life cycle management activities like annual report and safety report filling etc.Collaborate with company’s global and other regional regulatory team to author quality regulatory submissions for the pipeline products.Reviews health authority queries and co-ordinate global strategy for response.Provides adequate support (respond to deficiency letters) to company’s' global and other regional regulatory team for securing timely approval of regulatory submissions.Provide regulatory support to team, participate and provide regulatory advice in technical review.Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management and core team.Keep up to date with international legislation, guidelines ad customer practices in all countries that the company is exporting its products.Delivers electronic and paper regulatory submissions through co-ordination and execution to requirements and standards of each submission and national markets.Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects.Responsible for ensuring compliance to Company's submission standards, policies and procedures.Maintains a working knowledge of electronic and paper publishing systems and tools and how these are applied; fluency with multiple dossier format and translation requirements as required.Assists with interpretation of regulatory technical guidelines in order to produce business requirements and ensure that those requirements are implemented where appropriate at local level.Adheres to the required use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.As required, participates in implementation of national and regional process efficiencies and project learning sessions.Experience and Skills:Preferred 2-4 years of work experience in pharmaceutical or healthcare industryAbility to successfully plan workload against competing prioritiesSignificant 'Hands on' registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of a CMC writing and authoring, review and approval of labelling documents.Knowledge of global/regional regulatory guidelines and requirementsProven strength in logical, analytical and writing ability essentialStrong communicator, tested excellent verbal and written English language and customer facing skillsAptitude for customer service, facilitation, and conflict resolution, approaching all situations with enthusiasm and integrity, despite demanding workload, technical barriers and changing deadlines and requirements.Experience in project management through working submission management knowledge gained in Regulatory Operations or Regulatory AffairsProven success in a team environmentProven experience to working within a tightly regulated environmentProven technical aptitude and ability to swiftly learn and apply processes, systems and standardsExperience with submission management processes/systems and dossier compilation as per CTD is essential

---

Login or register for free to apply for this job

Get In Touch

---