27 Regulatory Strategies Jobs

As an Engagement Manager (Consulting) at PharmaACE, you will lead multiple end-to-end consulting engagements focused on the life sciences, particularly the pharmaceutical and biotechnology industries. Your role will involve partnering with senior executives and cross-functional teams to solve complex business challenges, develop data-driven strategies, and deliver high-impact insights that support implementation and ensure measurable value. Your goal will be to assist clients in developing and implementing strategies for growth and market leadership. Responsibilities: - Act as the pivotal, central point of contact for the client/pharma company for all respective engagements. - Develop and tr...

Role Overview: As a Regulatory Affairs Specialist at Amneal, your primary responsibility will be to prepare regulatory strategies for complex products such as injectables, ophthalmic, otic, topical gel, and 505(b)(2) products for both the US and EU markets. You will be drafting Pre-ANDA/Pre-IND/ScA meeting packages, controlled correspondences, and deficiency responses for complex products. Additionally, you will review API and finished product in-vitro characterization reports, collaborate with cross-functional teams, and ensure compliance with regulatory standards. Key Responsibilities: - Prepare Regulatory strategies for Complex Products including injectables, peptides, microspheres, lipos...

As a Regulatory Affairs professional in our company, you will play a crucial role in ensuring compliance with regulatory guidelines and maintaining the highest quality standards in the technical documentation for regulatory filings. Your responsibilities will include: - Conducting CMC review of technical documentation for regulatory filings to various markets, with a focus on the US market - Performing Gap Analysis and Remediation for module 3 -CMC - Developing and implementing regulatory strategies, processes, and timelines for grant of MA in regions like Africas, GCC, LATAM, ASEAN - Reviewing CTD dossiers, variations, change controls, renewals to ensure compliance with regulatory guideline...

As the Regulatory Head at our company located in Gurugram Analytical Lab near CRPF Camp, Gate No 1, Kadarpur Road, Gurgaon, Haryana - 122102, your role will involve developing and implementing regulatory strategies to support product development and market entry in compliance with global regulatory standards. You will lead the regulatory affairs department, ensuring timely submission of regulatory documents and approvals. Your responsibilities will also include ensuring that all company products meet regulatory requirements and are compliant with the laws and standards of the respective markets. Key Responsibilities: - Develop and implement regulatory strategies for product development and m...

As the Manager Regulatory Affairs at Kenvue, you will lead a team responsible for developing regulatory strategies across India, providing guidance on local requirements to product development teams. Your responsibilities will include managing regulatory deliverables for various products within your geographical and brand area, ensuring consistency in regulatory positions, and maintaining current products throughout their lifecycle. You will also represent the Regulatory Affairs function within the Franchise. Key Responsibilities: - Provide regulatory input and guidance to product development teams - Support business initiatives by influencing and approving the product portfolio - Conduct ri...

As a Manager - Business & Regulatory at Visakhapatnam with 10+ years of experience in the Finance domain, your role will involve the following key responsibilities: - Developing and implementing regulatory strategies to ensure compliance with industry standards - Managing CAPEX and OPEX budgets effectively - Creating and maintaining tariff models for financial planning - Conducting financial modelling to support decision-making processes To excel in this role, you are required to have: - MBA in Finance and BE qualification - Proficiency in CAPEX, OPEX, tariff modeling, and financial modelling,

As a Regulatory Affairs Director at Azurity Pharmaceuticals, your role involves ensuring the development and implementation of effective regulatory strategies for projects in development and approved. You will be responsible for providing regulatory guidance, requirements, and strategy for assigned projects to internal and external stakeholders, as well as leading the execution of regulatory strategies for pre-approval and post-approval activities. Your oversight of regulatory team activities will include managing filings, conducting technical reviews of documents, and ensuring regulatory compliance. - Develop and implement robust regulatory strategies and plans for projects, ensuring regula...

Key Accountabilities Propose efficient regulatory pathway for New Product Introduction ? Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs ? Provide regulatory input to CMC data, BE & CT protocol, study waiver justification etc. related to new products filing ? Collaborate with other functions such as R&D, Quality, Supply chain, Project Management, Medical, Clinical etc to deliver high quality dossiers, in accordance with business priorities ? Responsible for end-to-end filing of New products(Drugs/Biologics/Biosimilars etc) to CDSCO (Central Drugs Standard Control Organization), State FDA etc. ? Wel...

Role Overview: As a Regulatory Affairs Specialist at the company, your main responsibility will be to prepare, review, and finalize regulatory strategies for complex products such as injectables, ophthalmic, otic, topical gel, DDCP, etc., along with 505(b)(2) products for regulated markets like the US, Canada, and EU. You will be drafting, reviewing, and finalizing various regulatory documents including Pre-ANDA/Pre-IND/ScA/Scientific meeting packages, controlled correspondences, and deficiency responses for complex products. Additionally, you will collaborate with cross-functional teams, meet management expectations regarding timelines and quality, and provide training to new team members o...

Responsibilities: Supports the Northern Cluster team (as appropriate) for UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark products across the product portfolio. Supports the team with regulatory strategies (local and regional) that are in line with the business plan Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate. For example, but not limited to: Prepares and compiles regulatory submissions, response to questions, renewals, post submission/approval activities (including relevant updates to external websites such as emc, medicines.ie and In-Demand) Supports ad hoc projects (e.g., compliance review...

As a Regulatory Affairs Specialist, you will be responsible for maintaining accurate records of regulatory submissions, approvals, and correspondence with regulatory agencies. You will have the following key responsibilities: - Prepare, review, and submit regulatory documents, including applications, reports, and renewals, to relevant regulatory agencies. - Determine the types of regulatory submissions or internal documentation required for situations such as proposed device changes. - Develop and implement regulatory strategies to ensure compliance with domestic and international regulatory requirements. - Monitor regulatory changes and updates closely, assess their impact on current and fu...

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products Collaboration with partners to develop and execute global regulatory activities DMF preparations, review of changes and routine updates to Global Regulatory Agencies Dossier preparation...

Job Description Summary Join GE HealthCare as a Lead Specialist in Regulatory Affairs and play a pivotal role in shaping the future of medical imaging. This global leadership position offers the opportunity to drive regulatory strategies and lead cross-functional teams to bring innovative X-ray imaging products to market. Be part of a dynamic environment where your expertise will directly impact patient care and healthcare outcomes worldwide. 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 ...

Job Title: Head Regulatory Affairs Location: Daman About the client: PSS has been mandated to hire a Head of Regulatory Affairs for a leading R&D backed, manufacturing women's health organization with operations in over 140 countries worldwide. It is the world's largest manufacturer of Contraceptives devices. Job Purpose The Head of Regulatory Affairs will lead global regulatory strategies for medical devices and contraceptive solutions. The role will ensure compliance with domestic and international regulations (and support product approvals, quality assurance, and market expansion. Key Responsibilities Regulatory Strategy & Compliance: Develop and implement regulatory strategies for medica...

Position Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in emerging markets. Key Activities required for this job are as below Develop and implement regulatory strategies for biosimilar products in LATAM. Prepare, review, and submit dossiers for marketing authorization applications (MAAs), renewals, and variations in compliance with local requirements. Ensure adherence to regional regulatory reu...

Role Overview: You will be responsible for the CMC review of technical documentation for regulatory filings across various markets including the US. This will involve conducting Gap Analysis and Remediation for Module 3 - CMC. Additionally, you will play a key role in the development and implementation of regulatory strategies, processes, and timelines for the grant of Marketing Authorization in regions such as Africa, GCC, LATAM, and ASEAN. Key Responsibilities: - Reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. - Critically reviewing documentation intended for s...

Responsibilities Develop and implement regulatory strategies to ensure compliance with all applicable laws and regulations in the construction industry Monitor and evaluate regulatory requirements for construction projects and provide guidance to project teams Coordinate with internal teams, external consultants, and regulatory authorities to obtain necessary approvals and permits Review and interpret regulatory documents and communicate requirements to stakeholders Conduct audits and inspections to assess compliance with regulatory standards and implement corrective actions as needed Stay updated on changes in regulatory requirements and proactively address potential compliance issues Prepa...

You are a detail-oriented RA-CMC Associate responsible for supporting end-to-end submissions for global markets. Your expertise includes Lifecycle Management (LCM), Veeva Vault RIM, and managing complex Initial and Variation submissions. Your key responsibilities will involve preparing Variation documents and/or evaluating post-approval CMC changes to ensure compliance with global regulatory requirements. You will play a significant role in Lifecycle Management (LCM) activities by assisting in compiling and reviewing CTD dossier modules. Your tasks will also include compiling initial dossiers (Modules 2 & 3) for various countries such as US, EU, SA, WHO, ANZ, and others. You will be expected...

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed...

As a Drug Regulatory Affairs Specialist at MEDYUR PHARMACEUTICALS LIMITED, you will be responsible for ensuring compliance with regulatory requirements for our products. Your role will involve collaborating with cross-functional teams to drive successful product launches and maintain regulatory compliance. Your responsibilities will include preparing and submitting regulatory documentation, staying updated on global regulatory requirements, developing relationships with regulatory bodies, reviewing changes in regulatory policies, conducting regulatory impact assessments, maintaining regulatory files, and supporting regulatory inspections and audits. You will also collaborate with internal te...

You are a proactive and detail-oriented Assistant Manager in Regulatory Affairs (EU & UK) with a Masters Degree in Pharmacy (M.Pharm or equivalent) having 4 to 6 years of experience. You will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets, ensuring compliance with regional and international guidelines. Your key responsibilities will include conducting comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets, performing Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards, developing and implementing ...

You will be responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products. Your key duties will include overseeing global CMC regulatory activities for assigned projects, developing CMC strategy for submission documents, ensuring regulatory compliance, and participating in cross-functional project teams to define proper regulatory CMC filing strategy. Additionally, you will be expected to maintain high-quality standards, seek continuous improvement, share best practices within the CMC Regulatory teams, and engage in CMC Subject Matter Expert activities. To excel in this role, you should have a minimum level of job-related e...

At Lilly, the focus is on uniting caring with discovery to improve the lives of individuals worldwide. As a global healthcare leader headquartered in Indianapolis, Indiana, the organization is committed to developing and delivering life-changing medicines, enhancing disease management, and giving back to communities through philanthropy and volunteerism. The team at Lilly prioritizes putting people first and is dedicated to making a positive impact on a global scale. The Product Research and Development (PRD) organization at Lilly is instrumental in the development and delivery of quality medicines to patients. The diverse portfolio includes the development and commercialization of various m...

As a Regulatory Compliance Specialist in the construction industry, your role will involve developing and implementing regulatory strategies to ensure compliance with all applicable laws and regulations. You will be responsible for monitoring and evaluating regulatory requirements for construction projects and providing guidance to project teams. In this position, you will coordinate with internal teams, external consultants, and regulatory authorities to obtain necessary approvals and permits. Your responsibilities will also include reviewing and interpreting regulatory documents, as well as communicating requirements to stakeholders. As a Regulatory Compliance Specialist, you will conduct ...

This is a full-time on-site role for a Manager / Deputy Manager Regulatory Affairs located in Vadodara. As the Manager / Deputy Manager, your responsibilities will include developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. Your role will involve interacting with regulatory agencies, managing timelines, and ensuring that all products meet regulatory standards. Your key responsibilities will be to develop and direct global regulatory strategies for clinical, non-clinical, and CMC aspects. You will lead the preparation, review, and approval of submission documents f...