61 Regulatory Strategy Jobs

You are a fintech expert with in-depth knowledge of UPI, TPAP regulations, and NPCI certifications. You excel in fast-paced environments, where you manage high-impact projects, compliance, and tech integrations. **Key Responsibilities:** - Lead & manage the TPAP certification process with NPCI, ensuring smooth approval and compliance adherence - Develop and implement UPI strategies that align with regulatory frameworks while driving business growth - Ensure compliance with all NPCI, RBI, and other regulatory guidelines, including timely audits and documentation - Manage risk governance by implementing fraud detection, AML (Anti-Money Laundering), and cybersecurity best practices - Build stro...

Job Summary: We are seeking an experienced Head of Formulation Development (R&D) to lead and oversee formulation activities for oral solid dosage forms targeting regulated markets, including the US and EU . The ideal candidate will have extensive leadership experience in formulation R&D, strong technical expertise in complex generics and novel drug delivery systems, and a proven record of successful USFDA submissions. Key Responsibilities: Lead formulation development for new and existing oral solid dosage (OSD) products. Oversee the complete development lifecycle from pre-formulation to technology transfer. Ensure regulatory compliance with USFDA , EU , and other global standards. Collabora...

Job Description Minimum required Education: High School Diploma, Vocational Education / Bachelor's Degree in Business Administration, Communications, Quality Management, Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent. Minimum required Experience: Minimum 2 years of experience with Vocational Education in areas such as Regulatory Strategy, International Regulations, Medical Device Regulations, Product Development, Supply Chain, Continuous Improvement, Quality Management or equivalent OR no prior experience with Bachelor's Degree. Minimum required Certification: N/A Job title: One sentence description of role Your role: u2022 The greater imp...

Job Title Regulatory Affairs Specialist Job Description Minimum required Education: High School Diploma, Vocational Education / Bachelor's Degree in Business Administration, Communications, Quality Management, Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent. Minimum required Experience: Minimum 2 years of experience with Vocational Education in areas such as Regulatory Strategy, International Regulations, Medical Device Regulations, Product Development, Supply Chain, Continuous Improvement, Quality Management or equivalent OR no prior experience with Bachelor's Degree. Minimum required Certification: N/A Job title: One sentence description ...

As a member of the Asset & Wealth Management Strategic Transformation Office at Goldman Sachs, you will play a crucial role in overseeing large-scale transformations to enhance scalability, drive revenue growth, improve client experience, and optimize operating platform controls. This newly established entity is responsible for managing four critical functions: Product Management & Design, Change Management, Regulatory Management, and Monitoring & Testing. **Key Responsibilities:** - Analyze the applicability and impact of regulatory policies and rules on different business areas within Asset and Wealth Management - Collaborate with the team, key stakeholders, and regulatory experts to simpl...

Role Overview: You are applying for the position of Head of R&D at The Bland Company, a food and biotech startup focused on producing cost-efficient, highly functional ingredients through novel biochemical processes. As the Head of R&D, you will be responsible for leading scientific innovation and scaling manufacturing processes, particularly in the development of novel protein ingredients. Key Responsibilities: - Lead R&D efforts in protein chemistry, process optimization, and application science - Translate business objectives into clear technical goals and outcomes - Develop and execute the R&D roadmap, from refining the platform to validating client-facing applications - Identify and ass...

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all o...

Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall. Responsibilities Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017/745, and 21 CFR part 820). Participate in development of Regulatory Strategy for upcoming products against GSPR requirements. Participate in the development of QA strategies, recommendations for Continual improvement, Quality planning in conjunction with the needs of the company, for each product range and Quality Management System. Sustain and acti...

Execution and planning of compression / Coating / Capsule activity Troubleshooting of compression manchine / Coating machine / Capsule filling Recording of BMR, daily document, cleaning record, issuance of issuance of change part Exposure of audits (EU - GMP/ WHO / ROW / USFDA) Maintain the cleaniliness of area. Aware about the concept of GMP/GDP/Data integrity. Handling manpower

As a Senior Community Operations Manager for the APAC region, your role will involve leading the Escalation Program and collaborating with global counterparts to shape strategy for advanced support channels. You will oversee SORT (Social Media Response Team) and ECR (Executive Community Relations) to manage high-impact and sensitive escalations effectively. Your responsibilities will include managing operational excellence, stakeholder communication, and leadership to drive cross-functional impact. **Key Responsibilities:** - Lead the execution and continuous optimization of APAC escalation programs - Drive improvements in user experience by balancing speed, quality, and insight-driven decis...

Summary Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing ...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical d...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical d...

Job Description Summary Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Utilizes understanding of industry trends to inform decision making process. GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, a...

Role Overview: You will be responsible for developing technology architectural solutions for a less complex business area or supporting architectural services or governance activities. Additionally, you will support the elaboration of business solution architectures and utilize architecture patterns to suggest the most adequate utilization of technical platforms in support of the holistic solution architecture design. Your contribution will also be required to maintain the pattern catalogue in the respective domain. Key Responsibilities: - Develop technology architectural solutions for a less complex business area - Support the elaboration of business solution architectures - Utilize archite...

Netflix is one of the world's leading entertainment services, with over 300 million paid memberships in over 190 countries enjoying TV series, films and games across a wide variety of genres and languages. Members can play, pause and resume watching as much as they want, anytime, anywhere, and can change their plans at any time. This is a unique opportunity to make a real impact at the intersection of entertainment, policy, and global affairs. As Senior Manager, Global Affairs (India), you will play a pivotal role in shaping Netflix's policy agenda in one of the world's most dynamic markets. We're looking for someone who thrives on joining new dotsproactively spotting emerging issues, buildi...

Job Description Summary Provides regulatory strategy and direction to the business regarding healthcare regulatory requirements for post market compliance, working closely with healthcare regulatory bodies globally. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every d...

Job Description Summary Provides regulatory strategy and direction to the business regarding healthcare regulatory requirements for post market compliance, working closely with healthcare regulatory bodies globally. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every d...

Role & responsibilities 1. Regulatory Strategy & Submissions Develop and implement regulatory strategies for new product development and existing product life cycle management. Review and approve dossiers (CTD/eCTD/ACTD) for submissions in domestic and international markets. Manage new drug applications (NDA), ANDA, IND, DMF, variations, renewals, and post-approval changes . Ensure timely filing of submissions to DCGI, CDSCO, US FDA, EMA, MHRA, WHO, TGA and other authorities. 2. Compliance & Quality Ensure all products comply with local and international regulations, ICH, GMP, and pharmacopoeial standards . Review and approve labeling, artwork, and packaging materials for compliance. Stay up...

Around 7-10 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets. Good understanding of regulatory framework, including regional trends, for various types of applications and procedures. Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective. Responsible for managing (Authoring and Review) of biosimilar investigational product submission such as IND & IMPD for USFDA, EMA Authoring, review, and submission of BLA/MAA of biosimilar dossiers for US/EU/...

Role & responsibilities 1. Regulatory Strategy & Submissions Develop and implement regulatory strategies for new product development and existing product life cycle management. Review and approve dossiers (CTD/eCTD/ACTD) for submissions in domestic and international markets. Manage new drug applications (NDA), ANDA, IND, DMF, variations, renewals, and post-approval changes . Ensure timely filing of submissions to DCGI, CDSCO, US FDA, EMA, MHRA, WHO, TGA and other authorities. 2. Compliance & Quality Ensure all products comply with local and international regulations, ICH, GMP, and pharmacopoeial standards . Review and approve labeling, artwork, and packaging materials for compliance. Stay up...

Company Description Folius Labs is a category-defining nutraceutical and natural health products company at the intersection of scientific innovation and global wellness. Leveraging advanced research, digitized manufacturing, and AI-driven marketing, Folius Labs develops world-class, evidence-based supplements tailored for modern consumers. Following a successful and significant institutional fundraise, Folius Labs is positioned for accelerated expansion across the US and global markets. Role Description We are seeking a visionary Head of Growth & Co-Founder to architect and lead our next phase of scale. This founding leadership position is ideal for an accomplished D2C growth leader with a ...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Labeling Specialist responsible for Pre-evaluation of Reference Country Strategies, Deviation creation, Pre-evaluation of DLs, CCDS Update process till Global Dispatch, Binder creation, Attending Product PET meetings, Literature search , GLS QA check for Labeling Deviations Dashboard, Internal GLM meetings,...

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a Trusted Emerging Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top managem...

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...