AddressBusiness: Piramal Critical Care
Department: Regulatory Affairs
Location: Kurla, Mumbai
Travel: Low
JOB OVERVIEW:
The candidate should have 15-20 years of experience in Regulatory Affairs, predominantly in the European Market
The Chief Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care products in Europe
including the EU and other Rest of World countries (excluding the USA and Canada ). They will provide senior
level, experienced regulatory leadership to satisfy expected industry standards, applying in depth knowledge of
regulatory requirements and guidelines, procedures and agency precedents. The incumbent will develop and
implement submission strategies for new Marketing Authorisation Applications and complex European
submissions for variations using National and European multistate procedures (MRP, DCP etc.).
The Chief Manager will lead and ensure implementation of the planning, writing and review of all regulatory
submissions to support post Approval submissions including as appropriate and necessary Agency
correspondence and meetings. Provides guidance, supervision and leadership of subordinates and manages the preparation of regulatory
dossiers/submissions for assigned projects consistent with established regulatory policies.
The incumbent ensures the successful operation and function of the Regulatory Team to ensure business objectives are met or exceeded in accordance with overall Company goals and objectives, values and behaviours.
REPORTING STRUCTURE:
Reports to the Vice President, Regulatory Affairs
RELEVANT EXPERIENCE
Must possess ability to develop complex regulatory strategies for products registered in multiple regions.
Possess ability to effectively multi task, establish priorities and mentor more junior regulatory staff while working in a fast paced environment.
Must demonstrate strong leadership skills and ability to effectively interact with senior management.
Possess excellent written and verbal communication skills at all levels and geographies in the organisation.
Additionally, must possess extensive knowledge of European and Global regulatory requirements and demonstrable ability to function as the lead interface with European and other Global Regulatory.
Authorities. He/she must possess the ability to use precedent, experience and prior knowledge to develop
innovative/flexible approaches to achieve commercial goals.
Ability to interact positively with external contract manufacturers and other vendors as appropriate and
necessary.
Expert knowledge of the pharmaceutical business and proficiency at interpreting regulatory guidelines to convey regulatory options while supporting strategic business objectives.
Must have thorough understanding of technical and scientific information to advance project goals (CMC SME).
Must have sound knowledge of eCTD and the regulatory publishing requirements for submissions in the EU and other markets.
KEY ROLE & RESPONSIBILITIES:
The Regulatory AffairsChief Manager is responsible for providing leadership and guidance to a team
comprising of Individual Contributors, some of which may be located internationally.
Communication:
Use effective communication skills and effective working relationships to ensure consistent quality of work, alignment of functional goals and to provide updates on critical changes within relevant guidance, trends and department performance.
Knowledge :
Maintain up to date knowledge of data requirements, applicable SOPs, policies, regulations, guidelines, and industry standards. Knowledge areas include Europe, EU, ICH, WHO, GMP, stability, validation, and International (RoW) regulations, interprets policies, guidance and practices of applicable government agencies.
Leadership:
Actively participate in trade associations and industry groups & strive to influence changes in regulatory policies and guidance in the regulatory landscape.
Act as regulatory representative on multidisciplinary product and project teams, providing advice on regulatory activities and communicate regulatory requirements, execution pathways and strategies to the Project Team including authoring of Regulatory Strategy Documents (RSDs).
Act as interdepartmental liaison across functions for shared responsibilities and activities affecting the regulatory team.
Acts as a key senior leader in the Regulatory Leadership Team & contribute to the successful running of the Regulatory Department.
Collaborate with national and regional commercial heads to ensure product availability
Evaluate business opportunities and perform regulatory due diligence for in licensing and product acquisition for assigned region
Challenge self and others to overcome regulatory barriers and deliver high quality solutions to the business.
Management review
Approval of all submission packages including labelling, SmPC's and affected dossier components.
Approval of Change Controls in applicable systems for all regulatory impacted change control
Lead and drive all submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products and ensure activities are completed on time to ensure project deliverables and company goals are met or exceeded
Ensures the maintenance and accuracy of regulatory files, activity trackers and databases or other
systems to ensure prompt and accurate access to regulatory information (concerning current, pending
and future activities (applications, variations renewals etc.) (Smartsheet, SharePoint, MasterControl
etc.)
Reviews and approves as required all new or modified documents, such as SmPC's, PIL's, labelling,
SOP’s, SWI’s
Provide updates on changes to the external regulatory landscape as laws, regulations and guidance changes
Aware of the impact of any decisions made that affect company & department goals, customer safety and/or the availability of products to the customers worldwide.
Attends cross function business review meetings such as Safety Committee meetings
Attends off site agency meetings, calls and teleconferences with agencies, consultants and local partners to ensure success in regulatory matters
Process
Promote continuous improvement by proposing new or revised procedures and initiatives for operational effectiveness and efficiencies in partnership with other functions and/or with cross functional stakeholders and ensure appropriate documentation (SOP's etc.) is updated and maintained for all regulatory processes
Identify and develop entrepreneurial approaches and progress opportunities to remove obstacles to
regulatory actions to ensure product availability and continuity of supply
Reporting
Provide routine updates on assigned activities and projects across the team and continually develop
reporting tools using (e.g.) SmartSheet and other applicable means
People management:
Provide guidance, coaching, mentoring, training, supervision and leadership of subordinates in the local regulatory staff for further career development and skill development including the development and application of personal development plans
Effectively manage individuals and teams for assigned activities across assigned geographies and
products
Prioritize activities for individual direct reports and across the team for all activities working in accordance with business priorities and any external deadlines
Define, develop and implement overall performance objectives for the function and ensure compliance with all company values, behaviours and performance and development goals
Perform regular performance assessments of direct reports and provide feedback
Manage performance issues with individuals through appropriate measures which may include Personal
Improvement Plans and disciplinary procedures in conjunction with Human Resources
Lead the selection and recruitment of suitable and qualified staff and conduct interviews with Human Resources for any open positions
Support the assessment, revision, and improvement of training processes and requirements to meet
changing needs.
Integrate new team members (team or contractor) and ensure that training on SOPs and tools has been
completed in a timely manner
Serves as leader within the Regulatory structure in support of global organisational needs and assist in
the evolution of a global structure as the company grows
Training and development:
Complete all training on relevant SOP's and other business procedures as relevant to the function and role for self and ensures compliance across the team of the completion o assigned training (SOP’s, SWI’s etc.)
Design, develop and implement appropriate training plans and curricula for applicable SOP's and SWI's and ensure timely updates to training curricula in applicable systems
Manages departmental budget with focus on containing costs, review project budgets, potential overruns, and implement effective solutions
Strive for year on year overall reduction in operating costs through reduction in use of external consultants
Other :
Actively participate in cross company programs and projects affecting company culture and behaviours
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.
