62 Regulatory Strategy Jobs - Page 2

Role Overview: BridgeCounsels LLP, a premium Fractional General Counsel Firm based in New Delhi, is offering an offline internship opportunity for June-July 2025. As a Fractional General Counsel Firm, BridgeCounsels LLP acts as a long-term legal partner for startups, growth-stage companies, and emerging businesses. The firm provides continuous legal strategy, documentation, and compliance support without the need for full-time in-house legal teams. The focus areas of the firm's work include corporate advisory, commercial contracts, intellectual property (IP), technology law, and regulatory strategy, with a particular emphasis on AI and software-related matters. Key Responsibilities: - Work o...

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...

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 pass...

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 ...

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...

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...

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 ...

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 t...

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...

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 t...

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, A...

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 l...

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 ...

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 r...

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. ...

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, ...

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 re...

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 evalua...

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 inve...

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 wil...

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 deliver...

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 ...

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 chang...

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 heal...

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 reg...