Business:
Piramal Critical Care
Department:
Regulatory Affairs
Location:
Kurla
Travel:
Low
Job Overview
The Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care Products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities, country distributors or external partners. Will work closely and train other junior regulatory staff.
Key Stakeholders: Internal
External partners, Country Distributors, Health Authorities
Key Stakeholders: External
Cross-Functional Teams
Reporting Structure
Reports to: Senior General Manager-Regulatory AffairsDirect Reports: Yes
Essential Qualification & Experience
- Master's in Pharmacy degree, full time (Regulatory Affairs certification is preferred)
- Minimum of 8 to 10 years’ of experience in a pharmaceutical regulatory affairs department. Experience in leading dossier submission to Latam/ ROW markets and post approval variations.
Key Responsibilities
- Work closely with internal and external manufacturing sites to. assess post approval product chemistry, manufacturing and control (CMC) changes and determine appropriate global filing strategy
- Manage the assembly, compilation, submission and electronic publishing (if required) of documentation for product compliance, registration and life cycle maintenance.
- Support regulatory and broader development teams on strategic projects including gap analyses, meetings with regulatory authorities, product development and review, and other strategic deliverables.
- Evaluate business opportunities and perform regulatory due diligence for in licensing and product acquisition for assigned region.
- Maintain up-to-date knowledge of data requirements, applicable SOPs, policies, regulations, guidelines, and industry standards. Knowledge areas include ICH, WHO, GMP, USP, stability, validation, and US regulations.
- Review and interpret pertinent regulations and guidelines to develop proactive solutions to regulatory issues and challenges and communicate them to the other team members and functionalities within the organisation
Competencies
- Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders
- Expert knowledge and proficiency at interpreting regulatory guidelines.
- Possess excellent abilities to draft the CMC section of dossier
- Strong analytical, conceptual, problem-solving, and decision-making abilities
- Effective collaboration skills
- Proactive, with a strong ability to learn and adapt
- Advanced skills in Microsoft Office Suite (Excel, Word, PowerPoint, and Access)
- Critical Thinking – using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
- Proficient in both verbal and written communication
- Ensuring the maintenance of confidentiality at all times
- Capable of presenting multiple solutions creatively
- Displaying enthusiasm and a positive attitude
- Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
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.
