Job Description
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
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About The Team
Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.
PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.
Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.
Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.
