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Post : Specialist - Regulatory Affairs
Regulatory Strategy, Authoring of dossiers and Preparation of query response, Database update, Working on RA e-tools
• Develop the regulatory strategy and keep the document updated throughout the Life cycle of the project/product and to ensure the coordination with the different areas concerned: Clinical Development, R&D, Marketing and CMC related functions.
• Authoring and reviewing of dossiers: Ensure that all data supplied to the affiliates/regulatory authorities are of the highest quality possible in terms of both content and presentation, whilst meeting agreed deadlines.
• Work proactively with members of the internal stake holders to ensure project needs / transversal activities are met compliantly within agreed timelines.
• Assist and provide support in the preparation, distribution and follow up of registration documentation required to affiliates/ regulatory authorities.
• Proper utilization of regulatory e-tools.
• Provide support transversely.
• Maintain and update all the relevant databases up-to-date.
• Review of artworks as per the labeling requirements.
• Regulatory Impact assessment of Change controls (Variations).
• Preparation and review of documents required for Variation submission to Affiliates /Authorities.
• Tracking of all the changes and timely update on the status on fulfillment of conditions mentioned in variation approvals.
• Health Authority (HA), Commitments & Documents: Responsible for arranging timely and accurate tracking of regulatory authority requests and commitments related to approvals.
• Interaction with Health Authority (HA), Inspection Preparation/Support and timely submission of CAPA and other submissions related to Regulatory compliance.
• Time management skills to successfully meet deliverable. Anticipates delays in pre-defined submissions and either sets up corrective actions plan or proposes alternative solutions.
• Participates and Coordinate with cross functional teams for gathering the required information /documents required for authoring the dossiers and query response.
• Supports Site Regulatory Site Officer/Regulatory Product Manager with regard Regulatory Gap assessments.
• Supports Site project teams and external stakeholders as part of project execution.
• Ensure close collaboration with Quality and Process Improvement teams to ensure optimal processes and tools are developed and implemented. Lead creation and revision of relevant SOP's and work instructions. Evaluate and improve processes for submissions and regulatory information.
Duties & Responsibilities
• Act as a Team member and may need to play manager role in managing 1-2 people.
• Active participation in meeting the targets.
• To update the knowledge from time to time for effective delivery.
• Follow up with cross functional teams, ensure the target timelines are met.
• Handle requests, either internal or external, related to RA activities.
• Preparation and Submission of various applications, Responses etc from to Indian Health authorities.
• Meeting with Regulatory authorities from time to time to fulfill the business needs.
• Graduate/Post Graduate in Life sciences, Pharmacy.
• Minimum 6 - 10 years’ experience within Regulatory Affairs or in similar function in the Vaccine or Biological industry with good understanding of Industrial Operations experience is preferred.
• Demonstrated experiences in international and local regulatory affairs on Vaccines or Biological products.
• Previous Regulatory Affairs CMC authoring is must.
• Team handling.
• Demonstrated capacity to take up additional tasks.
• Excellent communication and CTD writing skills.
• Knowledge of Regulatory guidance.
• English proficiency, both oral and written.
• Multi-tasking ability.
• Candidate should have excellent interpersonal skills, be a self-driven proactive individual with skills in organization, building working relationships and communication.
• Basic software knowledge (Microsoft windows etc.) is must. Exposure to regulatory tools will be added advantage.
Qualification : B.Sc / B.Pharm / M. Pharm / M.Sc
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
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