Manager- Regulatory Operations

Business: Critical Care

Department: Regulatory Affairs

Location: Kurla, Mumbai

Travel: Low

 

Job Overview:

• Manage the team of Publishing expert(s), Manage the preparation, review, and submission of various electronic applications to the Food and Drug Administration (FDA), European Union (EU) and other regulatory bodies in accordance with government legislation, relevant guidelines, standards and national requirements.
• Provides guidance, supervision and leadership of subordinates.
• Support the vision for Regulatory Operations into the future 
  
   

Key Stakeholders: Internal: Cross-Functional: Regulatory New Products Team, Regulatory Life Cycle Management Team, Medical Affairs, Pharmacovigilance, Program Management  

Key Stakeholders: External: Health Authority (HA)

Reporting Structure: Associate Director, Regulatory Operations

Essential Qualifications:

• B. Pharm or equivalent in a science or related field preferred.
• Experience with document management systems and publishing software (tools) to support paper and electronic submission publishing. Other RIMS system knowledge.
• Experience with Lorenz DocuBridge essential.
• Working knowledge of eCTD structure, VNeeS, CVM application
• Knowledge of Regulatory systems such as RIMS 
• Previously managerial experience and mentoring of junior staff
• Must effectively multi-task, establish priorities and work in a fast-paced environment. 
• Must demonstrate ability to interact with management. 
• Possess excellent written and verbal communication abilities. 
  
   

Essential Experience:

• 5 to 10years or more relevant regulatory publishing experience in US & Europe including the EU. 
• Experience in Canada, Australia and other Rest of World markets is desirable.
  
   

Key Roles/Responsibilities:

• Manage the team of Publishing experts
• Lead and drive all publishing activities (planning, assigning, reviewing, coordination & submission) for assigned projects/products
• Publish and review Electronic Submission packages of New registration dossiers, Post Approval submissions in eCTD format and dispatch through Electronic Submissions Gateway (ESG), Common European Submission Portal (CESP) or equivalent submission portal.
• Publish and review the Veterinary product submission for US and EU region. 
• Documents Processing as per eCTD requirements for US, EU, TGA or relevant countries. 
• Ensure all publishing software meets the eCTD version requirements
• Stay up to date with the latest rules and regulations
• Manages compilation and submission of Periodic Adverse Event Reports for US and EU.
• Perform quality checks for document integrity and compliance to regulatory standards.
• Troubleshoot documents/eCTD publishing issues and provide guidance to company employees on best practices and regulatory requirements.
• Knowledge of Baseline submission and basic requirements of Baseline submission.
• Monitors the current eCTD requirements for USFDA, EMEA and other eCTD countries. Provides feedback to business on changes and impact/updates required to ensure Piramal remains compliant and competitive with regards the relevant systems.
• Provide input and guidance and advice in Regulatory Operations activity such as system(s) upgrades, new system selection and implementation.
• Develop User Requirements Specifications, Requests for Proposals in conjunction with the Director/Associate Director
• Provide input and guidance to all new Regulatory Systems such as EDMS. RIMS etc to ensure consistency and compatibility with existing systems e/g. Docubridge
• Design approaches to the automation of processes such as notifications of submissions and approvals
• Contribute the overall aims of the Regulatory Operations team by providing input into Business process transformation activities
• Provide metrics of publishing activities 
• Work closely and train junior regulatory staff as required.
• Attends off-site agency meetings, calls and teleconferences relevant top all aspects of publishing and regulatory operations
• Promote continuous improvement by proposing new or revised procedures and initiatives for operational effectiveness and efficiencies
• Actively participate in trade associations and industry groups & strive to influence changes in the regulatory landscape.
• Create/revise SOPs and work instructions as necessary (including global harmonization of SOPs).

People management:

• Provide guidance, mentoring, training, supervision and leadership of subordinates in the local regulatory staff
• Effectively manage individuals and teams for assigned activities across assigned geographies and products
• Ensure compliance with performance goals of direct reports
• Ensure compliance with company core values and behaviours
• Perform regular performance assessments of direct reports and provide feedback
• Define and develop individual direct reports personal development plans
• Manage performance issues with individuals through appropriate measures which may include Personal Improvement Plans and disciplinary procedures in conjunction with Human Resources
• Conduct interviews in conjunction with Human Resources for any open positions
• Coach and develop staff for further advancement or enhanced skill development.
• Define and develop appropriate training activities for subordinates 
• Lead the selection and recruitment of suitable and qualified staff.
• Integrate new team members (team or contractor) and ensure that training on SOPs and tools has been completed in a timely manner.
• Detect areas for improvement and support teams in their evolution

Competencies:

• Ability to work independently and within tight timelines. 
• Organized and able to prioritize submissions.
• Will need to collaborate intra and inter department and across sites globally to achieve the necessary objective. 
• Should be meticulous and detail oriented in his/her work including the review of documents and should have good technical knowledge.
• Should be able to multi-task effectively
  
   

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