36 Regulatory Strategy Jobs

Role: Plant Corporate Affairs Lead - Senior Executive / Assistant Manager Department: Corporate Affairs Location: Jagiroad, Assam Qualification: MBA / MSW / LLB Job description: Support in executing the organizational growth & transformation goals, and protect & promote the reputation of the business in the region Minimize expenditure through effectively managing the departmental budget whilst consistently identifying and initiating cost saving initiatives Liaise with relevant departments in the region to ensure mitigation of regulatory risks by way of identifying, assessing and creating mitigation plans for the same Responsibility to manage PR and represent DCBL in front of various external stakeholders as per business requirements Focus on building sustainable relations at political, bureaucratic & other administrative levels Liaise with govt departments and local bodies as for matters pertaining to laws and adherence to legal requirements Co-ordinate with various departments to timely file claims and speedy processing of the incentive proposals Stay updated on the key happenings, movements, and other developments in the region and share relevant information's to Regional Corporate Affairs Head

At EY, you have the opportunity to shape a career that is as unique as you are. With our global reach, support, inclusive culture, and cutting-edge technology, you have the tools to become the best version of yourself. We value your distinct voice and perspective, and we rely on them to help EY evolve and excel further. Come join us in creating an exceptional experience for yourself and in contributing to a better working world for all. EY is the sole professional services firm with a dedicated Financial Services Office, exclusively focused on the financial services sector. Our teams have consistently been at the forefront of pivotal events that have transformed the industry. If you are passionate about collaborating to address the most intricate challenges in the industry, we invite you to join our dynamic FSO team. EY's Financial Services Office (FSO) is a specialized business unit that offers a wide range of integrated services, combining deep industry expertise with strong functional capabilities and product knowledge. Our team has consistently led the way in adapting to and redefining the financial services landscape. The FSO practice delivers comprehensive consulting services to financial institutions and other key players in the capital markets, such as commercial banks, investment banks, broker-dealers, asset managers, insurance companies, energy trading firms, and the Corporate Treasury divisions of major Fortune 500 companies. Service offerings include market, credit, and operational risk management, regulatory consulting, quantitative consulting, structured finance transactions, actuarial consulting, technology enablement, risk and security, program consulting, and process & controls. As a prominent provider of consulting services, EY's Regulatory Compliance and Conduct Practice assists clients in navigating the evolving financial environment by translating business and regulatory strategies into actionable plans. In this role, you will have the opportunity to collaborate with leading financial institutions on critical compliance and strategic initiatives. Working closely with major banks, credit unions, and financial service providers, you will help them address regulatory concerns, strengthen their compliance frameworks, enhance customer service, and achieve sustainable results. By joining EY, you will play a significant role in shaping our clients" businesses and advancing your career with a market leader. This is a full-time position requiring 45-50 hours per week. Your key responsibilities will include: - Building relationships with top executives of clients and firm leadership - Providing guidance and expertise to support your team in developing strategic solutions - Ensuring the delivery of high-quality work consistently - Keeping abreast of current business and industry trends relevant to clients - Overseeing all aspects of engagements, from daily subject matter issues to project monitoring, risk management, and financials - Mentoring and coaching junior consultants to help shape their careers - Identifying and presenting new service offerings to clients for business development - Collaborating with a diverse team and fostering an inclusive work environment To qualify for this role, you need: - A bachelor's degree with approximately 3-5 years of regulatory compliance experience or a graduate degree with around 2 years of consulting or industry work experience - A degree in finance, accounting, law, or a related field; MBA, MS, or JD preferred - Strong communication skills for report writing, policy documentation, and client presentations - Excellent organizational skills and the ability to manage multiple priorities - Analytical skills to evaluate financial services industry processes with a compliance focus Ideally, you will also have experience in: - Working with federal regulatory agencies or compliance departments of financial services organizations - Interpreting regulatory pronouncements and expectations related to regulatory compliance - Developing functional requirement documents, business process insights, and compliance policies - Designing and implementing internal controls for financial services processes - Knowledge of consumer lending products, regulations, and regulatory requirements We are looking for individuals who are innovative, creative, and passionate leaders with strong project management and teamwork skills. If you have experience leading teams in client engagements and possess the ability to thrive in a fast-paced consulting environment, we want to hear from you. Join EY in building a better working world where long-term value is created for clients, people, and society. Our diverse teams, spread across 150+ countries, leverage data and technology to provide assurance and support clients in their growth, transformation, and operations. With expertise spanning assurance, consulting, law, strategy, tax, and transactions, EY teams are committed to finding innovative solutions to the complex challenges facing our world today.,

JOB DESCRIPTION: MAIN PURPOSE OF ROLE Summarize the main purpose of the role. Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions. MAIN RESPONSIBILITIES . As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. . Interacts with regulatory agency to expedite approval of pending registration. . Serves as regulatory liaison throughout product lifecycle. . Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC). . Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products. . Serves as regulatory representative to marketing, research teams and regulatory agencies. . Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. QUALIFICATIONS Education Education Level Major/Field of Study Or Education Level Associates Degree ( 13 years) ? Experience/Background Experience Experience Details Minimum 7 years The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: ID Infectious Disease LOCATION: India Gurgaon : BPTP Park Centra ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Contributes to all operational/clinical trial deliverables that are in scope of the specific JD, according to timelines, budget, operational procedures, quality /compliance and performance standards. Conduct/Contribute to study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development. May/may not be involved in identifying new sites for clinical trials; analyze capability and make recommendation for trial inclusion. Ensuring proper handling of all study conduct and close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation (if in scope of the specific JD). Responsible for education, implementation and compliance to standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards. Proactive operational planning with effective contingency and risk mitigation plans. Adherence to Novartis policy and guidelines and external regulations Minimum Requirements: Work Experience: Operations Management and Execution. Project Management. Financial Management. Collaborating across boundaries. Skills: Trial Planning and Feasibility. Over The Counter Product Development. Post Authorization Data Safety. Regulatory Strategy. Clinical Trial Set-up, Management & Conduct.

Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation. No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control. Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders -RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines. Provides high quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems. Maintains collaborative partnerships with stakeholders. Minimum Requirements: Work Experience: Cross Cultural Experience. Operations Management and Execution. Collaborating across boundaries. Project Management.

Intas is a leading global pharmaceutical company dedicated to the development, manufacturing, and marketing of pharmaceutical formulations. The company's mission is to meet unmet medical and societal needs through a fully integrated pharmaceutical value chain that spans across the globe. With a presence in over 85 countries, including major markets like North America, Europe, Latin America, and the Asia-Pacific under the brand name Accord Healthcare, Intas has experienced rapid expansion through organic growth and strategic acquisitions. The company upholds high standards of quality with products approved by leading global regulatory agencies such as USFDA, MHRA, and EMA. Intas also focuses on advanced areas like Biosimilars and New Chemical Entities to excel in healthcare. At Intas, success is attributed to the strength of its people. The company is committed to attracting and retaining top talent in the industry and creating an empowering environment that fosters innovation and excellence. This ensures that every employee contributes significantly to both the company's growth and advancements in global healthcare. **Job Title:** Asst Manager-Global Portfolio & Bus Dev. **Job Requisitions No.:** 13742 **Job Description:** **Purpose of Job:** The ideal candidate should possess basic knowledge of pharmaceutical development for Dossier preparation for the Global Market, particularly for oral/injection/topical dosage forms, and US/European pharmaceutical IP and Regulatory strategy. Experience in pharmaceutical business intelligence and business case analysis for new project selection and approval is desirable. This role involves interaction with internal and external departments within a multidisciplinary matrix team, necessitating cross-functional skills, leadership, and motivation. **Roles and Responsibilities:** - Identify, evaluate, and monitor Pipeline Projects - Participate in internal and external development monitoring, Budgeting, launch calendar, and Portfolio slide preparation - Optimize Portfolio and select New Projects - Contribute to project strategy and business case analysis - Maintain internal databases related to Portfolio and Pipeline - Coordinate training sessions for the BD team to update on Product details - Assist in the preparation of Intas Launch Landscape for strategic territories (US, EU, AUS, CAN, LATAM) **Skills Required:** - Strong understanding of the subject - Excellent communication skills **Qualification Required:** - M. Pharm or B.Pharm & MBA **Relevant Skills / Industry Experience:** - Experience in Project Management or Portfolio Management **Location:** Head Office, Ahmedabad, GJ, IN, 380054 **Travel:** 0% - 25% **Life at Intas Pharmaceuticals:** Intas thrives on the exceptional talent of its people, fostering individual potential and collective success in a dynamic environment. The company values diverse skills and perspectives united under a shared purpose to drive innovation and excellence in the pharmaceutical landscape. **Date:** 16 May 2025,

The Bland Company is a food and biotech startup dedicated to producing cost-efficient, highly functional ingredients through innovative biochemical processes. Our clean-label proteins are designed to assist food brands in reducing their reliance on egg-derived ingredients without sacrificing functionality. Currently engaged in trials with major CPGs and supported by top-tier investors and industry advisors, our founding team comprises biochemists and biochemical engineers committed to revolutionizing the food industry. As the Head of R&D, you will play a pivotal role in spearheading scientific innovation and overseeing manufacturing scalability. Your responsibilities will include leading a team of scientists and application experts focusing on protein chemistry, scale-up, and formulation science. This unique opportunity allows you to shape the technical direction of a company at the forefront of sustainable food production. Key Responsibilities: - Lead R&D efforts in protein chemistry, process optimization, and application science - Align technical objectives with business goals and ensure timely delivery - Develop and execute the R&D roadmap, from refining the platform to validating client applications - Identify and assess new scientific methods and technologies to expedite progress - Recruit, manage, and mentor a diverse team of specialists - Supervise experimental design, data analysis, and documentation - Collaborate with the founding team on IP strategy, regulatory planning, and scientific communication - Assist in scaling up R&D processes for manufacturing - Coordinate with external partners such as labs, CROs, academic collaborators, and suppliers - Contribute to strategic decisions on prioritizing food categories based on ingredient performance and customer feedback - Manage the establishment and operation of a state-of-the-art laboratory Requirements: - PhD in Biochemistry, Chemistry, Food Science, Biotechnology, or a related field - Over 10 years of industry experience in food ingredient or protein R&D, with a proven track record of leading projects and teams - Profound knowledge of plant protein structure, functionality, and structure-function relationships - Expertise in various protein modification methods, including physical, chemical, and biological approaches - Hands-on experience in protein purification and characterization techniques - Familiarity with food product development cycles and application testing - Strong project management, communication, and mentoring skills - Exposure to ingredient scale-up and technology transfer from lab to commercial scale - Bonus points for experience with upcycled ingredients and regulatory strategies What You'll Get: - A leadership role within a high-impact food biotech startup - Opportunity to lead a world-class scientific team and establish cutting-edge infrastructure - Access to a global network of advisors and collaborators - Fast-paced learning environment with high ownership and the chance to see your work in market-ready products - Competitive compensation package with equity participation - Collaborative and dynamic team committed to long-term success,

As the Head Risk and Regulatory Officer for our leading International Exchange located in Ahmedabad / Gandhinagar, you will be responsible for leading the Risk and Regulatory Team. Your key duties will include providing guidance, coaching, and assistance to the team members. You will collaborate with other Key Management Personnel to integrate Regulatory Compliance into business plans and operations. In this role, you will oversee the protection of the risk department's information technology and risk monitoring operations. You will also be in charge of presenting risk policies and regulatory initiatives to the board, regulators, and other stakeholders. Additionally, you will manage the risk, membership, and inspection department of the Clearing Corporation. Your responsibilities will involve liaising with Statutory Regulatory Committees and engaging with Regulators on policy-related issues. You will need to develop, implement, and supervise Risk & Regulatory Strategies and programs to ensure compliance with relevant laws and regulations. Keeping abreast of regulatory developments and modifications, you will assess their impact on the company and mitigate potential regulatory risks. Furthermore, you will ensure that internal policies, procedures, and the organization's operations align with legal standards. Managing regulatory inspections, overseeing matters, and monitoring the resolution of issues identified by IFSCA across all divisions will also be part of your role. Your contribution will extend to assisting various operations and business teams with strategic thinking. To excel in this position, you must possess a thorough understanding of industry standards, risk, and regulatory regulations relevant to the clearing company. Your leadership capabilities should be excellent, accompanied by outstanding negotiation and communication skills. Strong regulatory knowledge, attention to detail, and the ability to comprehend and implement complex regulatory requirements are essential. Moreover, you should have strong analytical and problem-solving skills, enabling you to manage multiple priorities and work effectively under pressure. A proven track record of establishing and maintaining strategic relationships with regulators and stakeholders is crucial. A collaborative and team-focused approach will be key to your success in this role. If you are an experienced professional with over 13 years of relevant experience and possess the mentioned skills and qualifications, we encourage you to share your updated CV with us at dhara@thepremierconsultants.com. Join us in shaping the future of Regulatory Compliance and Risk Management at our esteemed organization.,

Provide expert advice on product development, regulatory strategy, and market analysis to life sciences clients. Job Summary: We are seeking a knowledgeable Life Science Consultant to provide expert guidance on product development, regulatory strategy, and market analysis for clients in the life sciences sector. The ideal candidate will combine scientific expertise with strategic insight to deliver impactful solutions that drive innovation and business growth. Key Responsibilities: Advise clients on product development strategies and lifecycle management. Provide regulatory guidance and support for compliance with local and global standards. Conduct market research and competitive analysis to inform client decisions. Support innovation initiatives and facilitate workshops or training sessions. Prepare detailed reports, presentations, and recommendations for clients. Collaborate with cross-functional teams to ensure project success. Key Performance Indicators (KPIs): Project success rate and timely delivery Client satisfaction and feedback scores Number and effectiveness of workshops conducted Measurable impact of recommendations on client projects Skills & Competencies: Strong understanding of life sciences, pharmaceutical, or biotech industries Expertise in regulatory affairs and product development Analytical thinking and problem-solving skills Excellent communication and presentation abilities Ability to manage multiple projects and clients simultaneously

As a fintech expert with in-depth knowledge of UPI, TPAP regulations, and NPCI certifications, you will excel in managing high-impact projects, compliance, and tech integrations in fast-paced environments. Your key responsibilities will include leading and managing the TPAP certification process with NPCI to ensure smooth approval and compliance adherence. You will be tasked with developing and implementing UPI strategies that align with regulatory frameworks while driving business growth. Ensuring compliance with all NPCI, RBI, and other regulatory guidelines, including timely audits and documentation, will be crucial in this role. Managing risk governance by implementing fraud detection, AML (Anti-Money Laundering), and cybersecurity best practices will be essential. Building strong relationships with NPCI, banks, fintech partners, and regulatory bodies to drive seamless collaboration will also be part of your responsibilities. Staying updated with evolving regulations and industry trends to proactively address compliance risks and driving process automation for compliance documentation, reporting, and risk management to improve efficiency will be key aspects of your role. Additionally, training internal teams on regulatory updates, risk assessment, and compliance protocols to ensure smooth operations will be part of your responsibilities. Your must-have skills for this role include deep expertise in NPCI certification & TPAP regulatory processes, a strong understanding of UPI frameworks, compliance, and risk governance, as well as experience in stakeholder management, banking partnerships, and fintech operations. Excellent communication, negotiation, and leadership skills are also essential. Good-to-have skills include advanced negotiation and regulatory strategy skills, as well as a strong analytical and problem-solving mindset. Qualifications required for this role include a degree in Finance, Business, Technology, or a related field. In this role, you will own and drive a critical fintech function in a high-impact leadership role. You will have the opportunity to engage with NPCI, banks, and fintech leaders while working in a growth-driven environment that offers a competitive salary, industry-leading benefits, and career advancement opportunities. If you are ready to lead the next wave of fintech innovation, apply now!,

JOB DESCRIPTION: MAIN PURPOSE OF ROLE Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function. First level manager of a work team that may comprise professionals, technical and/or administrative staff. Typically without budget or hire/fire authority. Focuses on mentoring, coaching, and coordination. MAIN RESPONSIBILITIES As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throughout product lifecycle. Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC). Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products. Serves as regulatory representative to marketing, research teams and regulatory agencies. Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. QUALIFICATIONS Education Education Level Major/Field of Study Or Education Level Associates Degree ( 13 years) Experience/Background Experience Experience Details Minimum 4 years The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: EPD Established Pharma LOCATION: India Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable

JOB DESCRIPTION: MAIN PURPOSE OF ROLE Summarize the main purpose of the role. Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions. MAIN RESPONSIBILITIES . As the Specialist in the Regulatory Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. . Interacts with regulatory agency to expedite approval of pending registration. . Serves as regulatory liaison throughout product lifecycle. . Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC). . Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products. . Serves as regulatory representative to marketing, research teams and regulatory agencies. . Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. QUALIFICATIONS Education Education Level Major/Field of Study Or Education Level Associates Degree ( 13 years) Experience/Background Experience Experience Details Minimum 7 years The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: CRLB Core Lab LOCATION: India Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

As a member of the Asset & Wealth Management Strategic Transformation Office, you will play a crucial role in overseeing large-scale transformations to enhance scalability, drive revenue growth, improve client experience, and optimize our operating platform. The office consists of four critical functions: Product Management & Design, Change Management, Regulatory Management, and Monitoring & Testing. The Regulatory Management team within Asset & Wealth Management is responsible for managing the regulatory strategy and roadmap globally. You will be the key business partner for regulatory matters, focusing on Regulatory Solutions and Regulatory Controls. This includes assessing the impact of regulations on business activities and ensuring a robust control framework to evidence compliance. Your responsibilities will include representing the business on regulatory change governance forums, co-sponsoring new regulations, assessing the impact of new regulations on existing capabilities, and supporting the design of solutions to meet regulatory requirements. Additionally, you will advise on regulatory considerations for new products, funds, or trading activities. To fulfill your potential in this role, you will need to build a deep understanding of the Asset and Wealth Management business, collaborate with stakeholders to simplify complex regulatory challenges, drive business engagement on regulatory change matters, deploy appropriate methodologies for timely delivery of solutions, and build strong relationships with senior stakeholders. We are looking for candidates with a Bachelor's degree and 3-6 years of experience in management consulting or a related field in financial services with involvement in new regulation assessments and implementations. You should have an understanding of asset management products, the asset management operating model, and ecosystems. Proficiency in strategic thinking, analytical skills, project management, communication, relationship-building, and problem-solving is essential. Experience in regulatory product and platform management is preferable. At Goldman Sachs, we are committed to fostering diversity and inclusion and providing opportunities for professional and personal growth. If you require accommodations during the recruiting process, please let us know. Join us in our mission to help clients, shareholders, and communities grow while advancing your career at a leading global investment banking and management firm. Goldman Sachs is an equal employment/affirmative action employer.,

The Asset & Wealth Management Strategic Transformation Office is seeking a dedicated individual to join their Regulatory Management team. As a key business partner for regulatory matters, you will play a crucial role in managing the regulatory strategy and roadmap for the AWM business globally. This includes assessing the impact of regulations on business activities and ensuring a robust control framework is in place to evidence compliance. Your responsibilities will involve representing the views of the business on regulatory change governance forums, co-sponsoring new regulations, and performing detailed assessments on new regulations to identify their impact on existing AWM capabilities. You will be supporting the design of appropriate solutions to deliver regulatory requirements and advising on regulatory considerations for new products, funds, or trading activities. To excel in this role, you will need to build a deep understanding of the Asset and Wealth Management business by analyzing the applicability and impact of regulatory policies and rules to each business area. Collaboration with the team, key stakeholders, and regulatory experts within the firm will be essential to simplify complex regulatory challenges. You will be expected to exert influence, drive business engagement, and lead strategic cross-divisional discussions on regulatory change matters. The ideal candidate will have a Bachelor's degree and a minimum of 5 years of experience in management consulting or a related field in financial services with active involvement in new regulation assessments and implementations. An understanding of asset management products, the asset management operating model and ecosystems, and proficiency in working as part of a business or regulatory function owning the regulatory strategy, roadmap, analysis, and interpretation of new regulations are essential. Strong analytical, problem-solving, and critical thinking skills are required to provide creative and innovative solutions. Additionally, you should possess strong project management skills, excellent communication and relationship-building abilities, and a proven track record of owning, designing, and executing solutions for complex problems. Experience in Reg product and platform management is preferable, along with the ability to multitask and manage multiple projects simultaneously. Proficiency in MS Office, PowerPoint, and Excel is necessary, with an ability to learn new tools quickly. If you are looking to join a dynamic team and contribute to strategic regulatory management initiatives in the Asset & Wealth Management industry, we encourage you to apply for this exciting opportunity at Goldman Sachs.,

Apply Now Bangkok, Thailand About Agoda Agoda is an online travel booking platform for accommodations, flights, and more. We build and deploy cutting-edge technology that connects travelers with a global network of 4.7M hotels and holiday properties worldwide, plus flights, activities, and more. Based in Asia and part of Booking Holdings, our 7,100+ employees representing 95+ nationalities in 27 markets foster a work environment rich in diversity, creativity, and collaboration. We innovate through a culture of experimentation and ownership,?enhancing the ability for our customers to experience the world. Our Purpose Bridging the World Through Travel We believe travel allows people to enjoy, learn and experience more of the amazing world we live in. It brings individuals and cultures closer together, fostering empathy, understanding and happiness. We are a skillful, driven and diverse team from across the globe, united by a passion to make an impact. Harnessing our innovative technologies and strong partnerships, we aim to make travel easy and rewarding for everyone. Get to Know our Team: In the age of technology, things are constantly changing. The travel market is much the same, being more dynamic and complex than ever. Agodas Legal team is well suited to take on the challenges presented, adopting a proactive mindset to tackle challenges and solve problems. We are quick on our feet, decisive, and collaborate with multiple departments. We hire out-of-the-box thinkers that are well grounded with ethics and legal knowledge to ensure that Agoda achieves the right results, the right way. The Opportunity: Agoda is looking for a seasoned Legal Associate Director, Fintech & Payments with a proven successful track record (ideally with APAC experience) of providing strategic legal advice on regulated and non-regulated FinTech and Payment activities. As a senior FinTech and Payments lawyer reporting to the Senior Legal Director Fintech & Payments, you will support the successful execution of the business FinTech and Payments strategies, acting as a critical partner to helping develop, launch, and enable Agodas mission to deliver a world-class payments operation, globally. The selected candidate will have the chance to witness first-hand the investment in digital technology that helps take the friction out of travel. As you do so, you will advise on a range of legal questions related to regulatory strategy, scheme rules, product development and user experience, demonstrating familiarity with global payments regulatory contexts and payments industry commercial considerations that enable product management at this scale, and help to define the booking/ payments experience for the future of the company. You will lead complex projects, collaborate with cross-functional teams, and provide expert legal advice on our relationships with financial and payment services providers.This opportunity represents an exceptional chance to embed yourself within one of the worlds most exciting groups, based in the vibrant and thriving city of Bangkok, and help define the future for accessing travel experiences across the world. We welcome applications from both local and international candidates for this role. The position is based in Bangkok, and Agoda offers relocation support for successful candidate. Please note that remote work or working from locations outside of Bangkok is not available for this role. What youll get to do: You will report directly to the Senior Legal Director, Fintech & Payments, supporting all legal matters related to FinTech and payments impacting Agoda, globally. This will include: (1) ensuring that Agoda conducts all payments and FinTech activities in a compliant fashion, (2) advising on the design, structure, implementation, operation and lifecycle management of Agodas FinTech/ payments product initiatives globally and (3) leading on legal negotiations and contractual arrangements related to FinTech, payments and wider financing/ finance team activities. You will be a key member of the Agoda FinTech & Payments Legal Team and will engage with the wider Booking Holdings Cross Brand Payments and FinTech Legal group. You will work cross functionally/ in a matrix structure on a daily basis, including directly with the Senior Legal Director Fintech & Payments and the wider Agoda Legal team and other teams including key stakeholders in the technology, product, risk, compliance and finance teams. You will also interact with other senior stakeholders within Agoda, Booking Holdings, Booking Holding Financial Services and other Brands. You will support the Senior Legal Director FinTech and Payments to manage and develop a growing team, external counsels and team budgets. You will be accountable for horizon scanning, identify and advising on key emerging payments and financial services regulatory issues impacting Agodas business globally. You will be called upon to provide practical, commercial and actionable legal advice on a variety of regulated and unregulated financial and payments products and services. What youll need to succeed: Minimum 12 years of experience, ideally in FinTech, Payments, or Financial Services law, preferably with top-tier law firm experience and/or experience in a major Tech company. Law degree from a top law school, and excellent academic credentials. Native or fluent English speaking and writing skills. Excellent writing, negotiation and communication (verbal and written), and organizational skills. A strong understanding of the global payment regulatory environment and principles, familiarity with key legislation (with an APAC focus), with significant experience advising on cross-border and multi-jurisdictional regulatory issues. Experience in advising on all aspects of FinTech and payments, new product development and product delivery channels and working closely with stakeholders across different legal areas (Commercial, Regulatory, Consumer Protection, Privacy, etc.) and areas outside of legal (Tax, Treasury, Product, Finance Commercial). Strong project management and leadership skills, capable of managing multiple assignments and prioritizing appropriately. Comfortable with working under pressure. Ability to navigate change and ambiguity, and support others on the journey. Positive attitude, high level of integrity and intellectual curiosity with a strong solution orientated approach. Eager to learn new technologies and ideas. Comfortable navigating complicated and nuanced issues. Previous experience of working within a technology and digital legal environment is desirable. Relocation is provided. #Bangkok #Kualalumpur #Amsterdam #Paris #London #NewDelhi #Jakarta #Tokyo #Seoul #Singapore #Hongkong #melbourne #london #berlin #copenhagen #hongkong #seoul #tokyo #jakarta #manila #kualalumpur #singapore #hanoi #bangkok Equal Opportunity Employer At Agoda, we pride ourselves on being a company represented by people of all different backgrounds and orientations. We prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and innovation. Employment at Agoda is based solely on a persons merit and qualifications. We are committed to providing equal employment opportunity regardless of sex, age, race, color, national origin, religion, marital status, pregnancy, sexual orientation, gender identity, disability, citizenship, veteran or military status, and other legally protected characteristics. We will keep your application on file so that we can consider you for future vacancies and you can always ask to have your details removed from the file. For more details please read our privacy policy. Disclaimer We do not accept any terms or conditions, nor do we recognize any agencys representation of a candidate, from unsolicited third-party or agency submissions. If we receive unsolicited or speculative CVs, we reserve the right to contact and hire the candidate directly without any obligation to pay a recruitment fee. Copy Link Line WeChat LinkedIn Email Show more Show less

As a Regulatory Compliance Specialist, your primary responsibility will be to ensure that company products adhere to relevant regulatory requirements, including those stipulated by USFDA, FDA, EMA, and local regulatory bodies. You will be tasked with preparing and submitting regulatory documents such as INDs, NDAs, and MAAs to regulatory agencies. Additionally, you will play a pivotal role in developing and executing regulatory strategies that support product development and commercialization efforts. Your role will also involve staying abreast of evolving regulatory standards and providing guidance to internal stakeholders based on regulatory intelligence. You will coordinate and oversee regulatory audits and inspections, as well as review and approve product labeling and advertising materials to ensure compliance with regulations. Regular communication with regulatory agencies, such as the FDA, to address inquiries and issues will be part of your duties. Furthermore, you will be responsible for managing regulatory documentation, including submissions, approvals, and correspondence. Providing regulatory training and guidance to internal teams and monitoring company activities for compliance with regulatory requirements are also integral aspects of this role. This is a full-time, permanent position with a day shift schedule and a yearly bonus. The work location for this role is in-person.,

We are seeking a dynamic and experienced Specialist in Formulation Development team to develop the product formulation, ensure successful pilot & pivotal bio study, scale-up and exhibit, respond to deficiencies with proper justification. Ensure successful development of robust stable formula and process for given product from bench scale to commercial level. Roles & Responsibilities You will be responsible to Review and analyse data, collaborating with the Strategy design team to prioritize product criticality and plan preformulation studies. Coordinate with the preformulation team to strategize reverse engineering studies for comprehensive characterization. You will be responsible to evaluate available information and consult with experts to devise contingency strategies, ensuring proactive identification of potential formulation development challenges during the strategy development phase. You will be responsible to strategize and oversee product development, ensuring timely milestone achievements and effective formulation experiments. Coordinate daily analysis plans with the Analytical team, proactively addressing potential challenges and ensuring resource availability. Facilitate pilot and exhibit batch processes, collaborate on process optimization trials, and contribute to PDR and filing preparation for the development of a robust and stable bioequivalent drug product. You will be responsible to perform and review experiment documentation as per company systems (ELN). Write Batch plans, protocols, sampling plans etc. You will be responsible to ensure robust regulatory strategy for drug products by preparing effective and comprehensive response to regulatory queries related to formulation development. You will be responsible to facilitate laboratory and equipment maintenance and implementation of company safety standards by Preparing and reviewing Standard Operating Procedure (SOP) pertaining to the function. You will be responsible to provide guidance to develop formulation capabilities within team. Qualifications Educational qualification: Masters/Ph.D in pharma Minimum work experience: 7 years of experience in Formulation development Skills & attributes: Technical Skills Experience in end-to-end product development and troubleshooting. Developed Oral Solid dosage forms and delivered 3-4 products overall for regulated markets. Good theoretical and practical understanding of different stages of formulation research and development Demonstrates theoretical knowledge of commonly used analytical evaluation and characterization tools. Basic understanding of engineering principles & process controls related to equipment and process scale ups. Knowledge of agency requirement like Food Drug Approval (FDA) guidelines; Current Good Manufacturing process (cGMP), Current Good Laboratory Practice (cGLP), Standard Operating Procedures (SOPs). Complete understanding on prerequisites of preclinical/clinical studies, sourcing, analytical data interpretation and regulatory aspects Intellectual Property (IP) laws and patents; developmental quality aspects. BehavioralSkills Excellent communication and interpersonal skills. Business Acumen & Decision Making Strong analytical and problem-solving abilities. Performance oriented and good at building, leveraging relationship. Ability to work collaboratively with own team and cross-functional teams. Committed to Learning & Coaching the team.

As a Corporate Legal Specialist with 12 years of professional legal experience, you will play a crucial role in supporting our in-house legal operations at Rx100 Ventures, a sector-specific deep tech venture platform headquartered in Bangalore, India. Your responsibilities will include contributing to corporate advisory, regulatory compliance, documentation vetting, and legal risk assessments. This position offers a rich opportunity to gain hands-on exposure to cross-functional corporate legal activities in a fast-paced, innovation-driven environment. You will be responsible for supporting the review and negotiation of commercial agreements, non-disclosure arrangements, term sheets, and investment-related legal documentation. Additionally, you will perform legal and regulatory research to assist internal stakeholders with compliance-related queries and strategic legal positioning. Your role will also involve drafting and structuring business agreements, providing internal guidance on governance practices, legal risk mitigation, and operational legal frameworks, as well as coordinating with external law firms or advisors on specialized legal matters. To excel in this role, you should hold an LL.B from a recognized university, with an LL.M being preferred. You must have 12 years of relevant legal experience, ideally in corporate/commercial law within a firm or corporate legal team. A strong understanding of business law, compliance frameworks, and corporate legal processes is essential, along with skills in communication, legal drafting, and contract negotiation. It is crucial to be self-driven, able to manage tasks independently, and collaborate effectively within diverse teams. Additionally, you should be licensed to practice law in India under the appropriate jurisdiction. Key Skills required for this position include expertise in Business & Corporate Law, Legal Risk Advisory, Commercial Contract Review, Legal Compliance and Reporting, M&A and Due Diligence Support, IP & Confidentiality Agreements, Legal Interpretation & Drafting, Internal Legal Consulting, Regulatory Strategy, and Corporate Legal Transactions.,

As a Regulatory Affairs Specialist, you will play a crucial role in supporting the product lifecycle through obsolescence. Your responsibilities will include assessing changes made to the device post-launch to determine the regulatory impact of these changes on current clearance. You will ensure regulatory compliance by conducting thorough assessments and submitting the necessary documentation for product clearances and approvals from regulatory bodies such as the FDA and Notified Bodies. In this role, you will support new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based on regulatory changes. You will be seen as a valuable resource within the regulatory team, working with minimum supervision but keeping senior staff informed of your progress. Your tasks will involve developing and applying a basic understanding of regulatory frameworks, requirements, legislation, processes, and procedures. You will manage projects, write reports, coordinate regulatory activities, and execute regulatory assignments that are broad in nature. Additionally, you will assist in the development and review of standard operating procedures (SOPs) and contribute to regulatory strategy updates. You will provide regulatory input for new product development and product lifecycle planning, evaluate the regulatory impact of proposed changes to launched products, and investigate the regulatory history and background related to specific classes, diseases, therapeutics, or diagnostics for regulatory assessment. Your role will also involve determining and communicating submission and approval requirements to relevant stakeholders. To qualify for this position, you must have a Bachelor's or Master's degree in Regulatory Affairs, Engineering, or a related discipline. A minimum of 3-5 years of experience in a similar role within an R&D environment is preferred. Experience with post-market activities and change management will be advantageous, and holding an RAC Certification is also preferred. If you are looking to join a dynamic team where you can leverage your regulatory expertise to drive compliance and contribute to the successful launch of new products, this role may be the perfect fit for you. Apply now and be part of a team that is dedicated to ensuring regulatory excellence and innovation in the medical device industry.,

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as delivering all regulatory milestones for higher complexity products. You will also be accountable for leading the development and review of the CMC Regulatory Strategy Document for projects of increasing complexity. In addition, you will be required to support new technology development within the company and demonstrate an unwavering focus on compliance in all activities. Your technical skills should include expertise in the preparation and review of dossiers, response to queries, and communication with agencies for markets like the US and EU. Furthermore, you should have proven experience in critically reviewing scientific information and possess superior oral and written communication skills in multicultural settings. The ideal candidate for this role will have demonstrated leadership skills, including the ability to generate innovative solutions to complex regulatory problems and effectively work with key stakeholders. You should also exhibit flexibility in responding to changing priorities and possess effective leadership, communication, interpersonal, and negotiating skills. Additionally, you should have good inter-personal skills with the ability to direct multi-departmental functions. This role requires a seasoned professional who is proficient in English, with additional language skills considered a plus. A minimum educational requirement of M-Pharm in pharmaceutical sciences is essential for this position. Lastly, you may be required to manage or mentor junior team members as part of your responsibilities.,

The Asset & Wealth Management Strategic Transformation Office is responsible for overseeing comprehensive large-scale transformations. The primary objectives of the office include enhancing scalability, driving revenue growth, improving client experience, and elevating controls to optimize the operating platform. This group consists of four critical functions: Product Management & Design, Change Management, Regulatory Management, and Monitoring & Testing. The AWM Regulatory Management team plays a key role in managing the regulatory strategy and roadmap for the AWM business globally. As the primary business partner for regulatory matters, the team is responsible for Regulatory Solutions and Regulatory Controls. Regulatory Solutions involve assessing the impact of regulations on business activities, participating in regulatory change governance forums, and supporting the design of appropriate solutions to deliver regulatory requirements. Regulatory Controls ensure a robust control framework is in place to evidence compliance. As a member of the AWM Regulatory Management team, you will: - Build a deep understanding of the Asset and Wealth Management business by analyzing the applicability and impact of regulatory policies and rules to various business areas - Collaborate with the team, key stakeholders, and regulatory experts to simplify complex regulatory challenges - Drive business engagement and lead strategic cross-divisional discussions on regulatory change matters - Utilize appropriate methodologies and governance tools to deliver analysis and agreed solution approaches in a timely manner - Establish strong senior stakeholder relationships necessary for complex analysis across multiple businesses Skills & experience we are looking for: - Bachelor's degree and 3 - 6 years of experience in management consulting or a related field in financial services with active involvement in new regulation assessments and implementations - Understanding of asset management products, the asset management operating model, and ecosystems - Proficiency in regulatory strategy, roadmap, analysis, and interpretation of new regulations for the business - Strong strategic mindset, analytical skills, problem-solving abilities, and critical thinking - Project management skills including defining business cases, articulating issues, solutions, and managing risks - Excellent communication and relationship-building skills with the ability to influence staff at all levels - Proven track record of owning, designing, and executing solutions for complex problems - Experience in Reg product and platform management is preferable - Ability to multitask and manage multiple projects simultaneously - Proficiency in MS Office, PowerPoint, and Excel, with the ability to learn new tools quickly Goldman Sachs is committed to fostering diversity and inclusion within the workplace and beyond. The firm offers numerous opportunities for professional and personal growth, including training and development programs, firm-wide networks, benefits, wellness offerings, personal finance resources, and mindfulness programs. Learn more about the culture, benefits, and people at GS.com/careers.,

As an Assistant Manager/Manager in Regulatory Affairs with 7-11 years of experience, you will report to the Head of Regulatory Affairs and be responsible for handling regulatory activities for the Canadian market. Your primary focus will be to develop regulatory strategies for submissions, assess changes, and manage the product life-cycle across various dosage forms. You will also be involved in compiling New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS), as well as conducting module-wise document reviews. Your role will encompass reviewing documents and artworks to ensure compliance with eCTD (electronic Common Technical Document) guidelines, as well as overseeing change controls and performing gap analysis for new product filings. Additionally, you will be tasked with maintaining product life cycles and collaborating with cross-functional departments to evaluate, approve, and implement change proposals, deviations, and escalations. Furthermore, you will be responsible for preparing internal guidance documents to support regulatory activities within the organization. This position is based in Pune and focuses on the Canadian market, encompassing all types of dosage forms. A degree in B.Pharm/M.Pharm is required to qualify for this role.,

As the Regulatory Affairs Manager at Natural Biogenex Pvt. Ltd. (NBPL), you will be responsible for overseeing the regulatory submission processes, ensuring compliance with all applicable regulations, and managing the regulatory strategy for pharmaceutical products. Your role will involve working closely with various departments such as R&D, Quality Assurance, and Marketing to facilitate the development and commercialization of pharmaceutical products. Your key responsibilities will include developing and implementing regulatory strategies for drug development and approval, guiding regulatory requirements and compliance to internal teams, preparing and submitting regulatory documents to health authorities, managing communication with regulatory authorities, monitoring changes in regulations to ensure compliance, working collaboratively with cross-functional teams, managing multiple regulatory projects simultaneously, and maintaining accurate records of regulatory submissions and communications. To excel in this role, you should possess a Bachelor's or Master's degree in pharmacy, along with a minimum of 12 - 15 years of experience in regulatory affairs within the pharmaceutical industry for filing products in various regulatory agencies. You should have a strong understanding of regulatory guidelines and compliance requirements (such as FDA, EMA, etc.), excellent communication, organizational, and project management skills, and the ability to work collaboratively in a fast-paced environment. By joining Natural Biogenex Pvt. Ltd., you will have the opportunity to be a part of a leading API manufacturing company with cutting-edge technology and compliance standards. You will work in a state-of-the-art Quality Control Laboratory with global regulatory standards, contribute to regulatory audits and pharmaceutical quality excellence, and benefit from competitive salary and professional development opportunities.,

As the DM- Regulatory Affairs at Olympus Medical Systems India Private Limited, your primary responsibility will be to oversee Indian regulatory affairs activities related to Gastrointestinal (GI) & Olympus products. You will also be responsible for advising and consulting with stakeholders about compliance with CDSCO, BIS, WPC, and other applicable regulatory bodies. Your role will involve implementing best practices and contributing to both the strategic and operational functions of the regulatory affairs team. Your key responsibilities will include assessing regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. You will evaluate the regulatory environment and provide internal advice throughout the product lifecycle to ensure product compliance. Anticipating regulatory obstacles and emerging issues, you will develop solutions and identify requirements and potential obstacles for market access distribution. Furthermore, you will assist in the development of regulatory strategy, update strategy based upon regulatory changes and evaluate proposed products for regulatory classification and jurisdiction. You will determine requirements for regulatory submission, approval pathways, and compliance activities while providing regulatory information and guidance for product development and planning. In addition, you will compare regulatory outcomes with initial product concepts, negotiate with regulatory authorities, and identify the need for new regulatory procedures. You will help train stakeholders on current and new regulatory requirements, provide regulatory input on global regulatory requirements to product development teams, and advise stakeholders of regulatory requirements for quality, preclinical, and clinical data. You will also be responsible for assessing the acceptability of quality, preclinical, and clinical documents for submission filing, evaluating proposed changes for regulatory filing solutions, and monitoring the progress of the regulatory authority review process. Communication and interaction with regulatory authorities before and during the development and review of regulatory submissions will be crucial aspects of your role. To be considered for this position, you are required to have a qualification of M. Pharma/B Pharma along with a PG Diploma in Drug Regulatory Affairs. The preferred experience includes 12 to 15 years of working experience in a customer-oriented position in an international organization. Proficiency in MS Office, particularly Excel, and fluency in oral and written communication in English are essential. Key competencies for this role include business acumen, customer focus (internal and external), execution excellence, domain expertise, effective communication, developing organizational talent, and team leadership. By applying your expertise and knowledge, you will play a vital role in ensuring regulatory compliance and contributing to the success of Olympus Medical Systems India's regulatory affairs team.,

As a Regulatory Affairs Associate, you will be required to hold a Master's Degree in M. Pharm or M. Sc. with a specialization in Pharmaceutics, Industrial Pharmacy, Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, Biochemistry, or Microbiology. A minimum of 2 to 6 years of hands-on experience in R&D within Manufacturing or Import companies, specifically in MNCs and Generics, is essential for this role. Proficiency in CDSCO and Central Licensing Agency - New Delhi (SUGAM) skills, including Agency Liaison, is a priority as applications lacking these skills will not be considered. Your responsibilities will include understanding new client requirements, scope, deliverables, and timelines, reviewing and finalizing Gap Analysis Reports, effective collaboration and communication with internal and external stakeholders, technical writing of regulatory documents, liaison with licensing authorities such as CDSCO, training internal technical team members on the latest updates and guidelines, and coordinating with stakeholders. Key responsibilities will involve Regulatory Strategy, KOL/SME/Agency and Network-Access, Review of Documents/Dossiers and Gap Analysis, and Technical Writing of Regulatory Documents. This is a full-time position with a day shift from Monday to Friday, based in Bangalore (Cunningham Road), serving the Indian market for API and Finished Formulation. A willingness to travel up to 25% of the time is required, with a start date of 04/08/2025, and the application deadline is 07/07/2025.,