2 Us Regulations Jobs

Job Description 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 Affairs Direct Reports: Yes Essential Qualification & Experience Master&aposs 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. Show more Show less

Role & responsibilities Reg BA (JD) CMT Trade Reporting team is responsible for change management, analysis, definition and delivery of solutions for business requirements resulting from the introduction of new and updated Trade Reporting rules by the various Global Regulatory Bodies, such as HKMA, MIFID2, CFTC, EMIR, and SFTR, working closely alongside the IT function • The industry remains under increased regulatory pressure across our businesses as these reporting obligations are put into effect; therefore a substantial amount of cross functional change is required, and is coordinated by the CMT Trade Reporting team to ensure bank adhere to regulatory objectives in the most time, cost, controlled and technologically efficient manner. Key Accountabilities Impact on Business The role of the Business Analyst is to support the Project Manager(s), and Product Owners to deliver critical analysis to deliver the relevant project. • The BA is responsible for the following activities and deliverables: • Responsible for the end to end analysis for Regulatory Change projects such as (SFTR, HKMA, MiFID, EMIR, CFTC etc) and internal Strategic Architecture implementations • Work with FO stakeholders, Compliance, Asset Class Business Managers and Technology in order elicit requirements, offer solutions and deliver change to satisfy regulatory demand and ensure sustainable Operational Controls • Challenge and question required business flows where necessary in order to define an optimal and efficient business processes • Produce Business Requirements relating to the Reporting of any trades and transactions across major Global Regulators (e.g. SFTR, CFTC, EMIR, HKMA, MAS) to Trade / Swap Data Repositories (e.g. DTCC, Unavista, US SEC, etc). • Fully document scope of all related business requirements, relating to each deliverable, and ensure these are understood by by business and operational stakeholders and IT teams • Link with Asset Class Business Managers and Technical Specialists in order to write documents that can then be signed off and used as the basis to construct technical documents used to support the necessary changes. • Provide input into the generation of test cases to support the Test strategy and support any analysis to resolve defects. • Work closely with the Product Owners and Architecture teams to ensure all regional deliveries are consistent with the global approach. • Develop and maintain strong working relationships with key stakeholders (Business, Operations, Compliance, and IT) in understanding the impact of each business initiatives on regulatory reporting. • Work to ensure potential gaps and issues in solutions are risk assessed, and appropriate solutions/controls are defined. Work with BAU teams to ensure there is an appropriate enduring model for data ownership, exception management, and ongoing maintenance for reporting compliance • Establish a model that ensures all artefacts and deliveries are of a consistent high quality, .timely and accurate • Ensure that artefacts are of a suitable level, cohesiveness, and availability to be available to show to auditors, regulators, and evidence how bank is meeting its obligations Desired profile Qualifications : Knowledge & Experience / Qualifications Strong business writing skills with ability to communicate complex ideas simply and convincingly, ask insightful questions, break analytical challenges into workable components, and draw meaningful conclusions. • Highly motivated, with strong organizational, analytical and problem solving skills, possessing follow through, ability to manage, monitor, track, and clearly communicate progress on multiple initiatives • Experience of Product Based Planning a distinct advantage • Evidence of effective relationship management (both internal and external) • Experience in producing both business requirement and functional requirements is essential • Experience with working as a conduit between Business and Technology teams to ensure requirements are clearly understood and solutions delivered • Experience within Technology with a track record delivering Regulatory Trade Reporting requirements • Excellent documentation and communication skills • Positive ‘can do' attitude, and problem solving ability • Ability to work effectively to strict timelines and deadlines, and do “whatever it takes” to meet deadlines • Prior experience of working on a Trade / Transaction Reporting programme such as CFTC, HKMA, MAS, ASIC, DFA and/or EMIR). • Awareness of Trade Reporting mechanisms (e.g. connectivity to GTR, FpML etc) Understanding of CFTC Re-write or EMIR Refit, DTCC / CFTC Technical specifications, Trade State / PPD Reporting would be an advantage. Preferred candidate profile