[Janssen] RA specialist

[Janssen] RA specialist

Johnson & Johnson Vision
2-5 years
Not Specified

Job Description


Overall purpose of job: - Coordinates, compiles, and submits new drug applications, abbreviated new drug applications and the product life cycle management required prior TFDA approval to the regulatory agencies. - Responsible for preparation of life cycle management submissions to the Health Authority, The submissions are dispatched Globally under the scope of the Regulatory Management Centre (RMC). Essential duties and responsibilities: Regulatory Strategy Contributes to regulatory strategy for new and/or marketed products for Taiwan depending of the scope of her/his responsibilities. Develops filing/local submission plan for variations, labelling update based on CCDS or reference country PI where it is applicable. Follows regulatory status of competitor products and assesses impact on regulatory strategy. Identification of data requirements (e.g., clinical trials, CMC, stability program, local studies) and dossier/legal certificate requirements. Interacts and aligns with internal/local business partners (e.g. Medical Affairs, Marketing, New business opportunities, legal, etc) to contribute with product strategy, local registration and launch activities. Discusses and aligns filing plans and timelines with regional RA office and AP&LA liaisons, where it is applicable. Contribute to standardization/new systems and processes to ensure efficiency gains and to support business continuity. Registration Dossiers Interacts with Health Authorities related to pre-submission activities, review & approval processes and post-approval commitments, on behalf the regulatory affairs local head, where it is applicable. Addresses questions from HA related to approval process aligned with local RA head, regional office and AP&LA liaisons. RMC Receive CLCN and CMC variations from the AP RMC and identify if submission to the local Health Authority is required. Assess dossier for impact to country registration. Provide details on submission strategy to the AP RMC to ensure timely updating of compliance tracking systems. Prepare submission dossier based on global dispatch and country specific requirements. Request country specific documents for submission, such as data administration, translation, artwork, samples and certificate. Work with the RMC Liaison who will be the single point of contact with global teams, to resolve any issues with the submission package from global. Ensure country specific requirements are accurately maintained in RIACS. Receive HA queries and send to the RMC Liaison assigned to the product portfolio for management. Complete any post-approval activities required for a life cycle management submission. Participate in team meetings, activities, and trainings as a full member of the LOC regulatory affairs team. Communicate local regulation changes in a timely manner to the RMC Liaison who has been assigned as the country/cluster partner. Labeling Customizes Company Core Data Sheet (CCDS) or reference country PI to local PI as per local regulations. Submits and obtains HA approval for initial and updated versions of local PI as derived from CCDS or reference country PI Tracks submissions and approvals (version controlled). Engages in other labeling-related responsibilities (logistics, review and approval, local implementation etc.). Develops metrics and measure compliance of processes under her/his responsibility. CMC Variations / Renewals Provides requirements and renewal calendar to CMC RA organization. Submits CMC variations and renewals on globally- and locally-sourced products. Tracks submission and approvals (version controlled). Post Approval Commitments Track and inform post-approval commitments are acted upon, as required. Processes Ensure the development and implementation of local SOPs /LIMs (if required). Special requirements: . Excellent verbal and written communication skills in local language- proficiency in written and oral English. . Proficient use of technology including MS office programs and Internet resources. Other features of the job: Work relationships - Internal: Marketing Team, Medical Team, Direct Supervisor, Business Unit Head, New Product Development Manager RA regional office, Legal, Supply chain, HCC, Market Access, GCO. Work relationships - External: Interacts with Health Authorities, Trade Associations, Governance Job Requirements Essential knowledge and skills: Essential- . Degree in Life sciences (e.g., Chemistry, Biology). . Minimum of 1.5 years of relevant pharmaceutical industry experience. . Hands- on experience in pharmaceutical product registration. . Demonstrated leadership and organizational skills.Job Requirements . Understanding of commercial business. . Demonstrated ability to handle multiple projects. . Working knowledge of local regulations and guidelines related to drug development and registration. . Experience in Health Authority interactions. Ability to act as company spokesperson with Health Authorities. . Excellent verbal and written communication skills in local language- proficiency in written and oral English. . Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor. . Proactive team player, able to take charge and follow-through. . Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment. . Proficient use of technology including MS office programs and Internet resources. Preferred- Pharmacist is a plus. Core competencies required for this role: Essential - . Communication Skills . Market Knowledge . Business Relationship . Project Management . Regulatory Environment . Reimbursement . Planning & Organization . Research & Analysis . Science & Therapeutic Knowledge . Strategic Thinking Important - . Interpersonal skills . Ability to manage multiple projects Key Motivational Factors: Core Factors - . Passion in connecting with others . Desire in achievement Job Specific - Continuous Learning Qualifications See above Primary Location Taiwan-Taipei-Taipei- Organization Johnson & Johnson Taiwan, Ltd. (8580) Job Function Regulatory Affairs Requisition ID 2206042928W

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