3222 Regulatory Affairs Jobs - Page 50

The role is to assist in providing the regulatory administration activities of regional regulatory function. This position is responsible for organizing, revising and maintaining all regulatory documents within the regulatory department. The individual will assist in the registration of products by preparing and submitting documentation needed for registration in India. The individual will assist the team in any other responsibility as desired for regulatory work. Education: Postgraduate in Master of Business Administration (Pharmaceutical Management) Graduate in Pharmacy Experience: 4-5 years experience in FMCG/Pharma Industry in the field of pharmaceutical, general category products

Key Responsibilities Provide regulatory strategy and compliance guidance for SaMD and software-intensive medical devices . Interpret and apply global regulations (FDA, EU MDR, UKCA, Health Canada, etc.) and standards (ISO 13485, IEC 62304, ISO 14971, IEC 82304-1). Prepare and review regulatory submissions (510(k), CE Technical Files, UKCA documentation). Support risk management , cybersecurity compliance , and software lifecycle documentation . Collaborate with engineering teams to align design controls, verification/validation, and usability engineering with regulatory requirements. Stay updated on evolving regulations for AI/ML-based SaMD and digital health solutions. Required Skills & Exp...

** Urgent opening with FMCG Industry** Job Title: Associate Manager / Manager - Food Regulatory Affairs International Markets Location: Ahmedabad- ZCP, Gujarat, India Role: Responsible for ensuring compliance with all food safety and regulatory requirements for the organizations products. This role involves supporting the preparation, submission, and maintenance of regulatory documents and licenses, coordinating with internal and external stakeholders, and staying updated with evolving food regulations of respective international markets (UAE, Africa, Australia and Newzland, EU and USA). The incumbent will play a key role in safeguarding the companys regulatory standing and facilitating mark...

SUMMARY Purpose of Job: Support the effective management of company assets throughout their lifecycle, ensuring accuracy, accountability, and compliance. The role focuses on maintaining updated asset records, monitoring utilization, and assisting in the reconciliation of fixed and movable assets. The position is responsible for providing timely and accurate asset-related data to management; assisting in audits. Job Description: Through Google Sheet operate CAPEX PR & PO. Maintain equipment details. Maintain vendor service PO. It is maintained totally through Google Sheet with a variety of reports. Good knowledge of Excel, Word & PowerPoint. Requirements Required relevant experience (Type and...

We're Hiring: Regulatory Affairs CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or biotech setting. Strong experience in US FDA regulations and ICH guidelines. Experience in handling pre- and post-approval submissions is required Interested candidates can share their resumes on sheetal.na@peoplefy.com

Founding Leadership Member/Director/Senior Consultant - Medical Operation/Medical Affairs Domain Expertise Areas & Role & Responsibility: Should be able to do as follows: Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in coll...

Founding Leadership Member/Director/Senior Consultant - Medical Operation/Medical Affairs Domain Expertise Areas & Role & Responsibility: Should be able to do as follows: Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in coll...

Education Qualification: B.Sc. / M.Sc Experience : 1 to 2 Years 1.Technical Data Management Data Acquisition, Data Analysis, Data Documentation, Data Distribution 2.Communication Customer Communications, Internal Communication, Cross Functional Collaboration 3.Review in Technical Documents 4.Regulatory Knowledge and Compliance Regulatory Research and Monitoring, Compliance Management, Risk Assessment, Training and Knowledge Sharing 5.Communication with Internal and Factory Teams Internal Team coordination, Factory liaison, Process Optimization. 6. Regulatory Requirement

Key Responsibilities: Develop, implement, and maintain robust financial crime prevention policies and procedures, including anti-money laundering (AML), fraud, sanctions compliance, and counter-terrorism financing (CTF). Lead and manage financial crime risk assessments and due diligence processes. Oversee investigations related to suspicious activities, ensuring timely escalation and resolution. Ensure compliance with applicable laws, regulations, and industry standards. Coordinate with internal departments and external regulators on compliance issues. Monitor and report on regulatory changes and implement necessary adjustments. Provide training and awareness programs on financial crime and ...

Role Description: As the Finance Head, the candidate will play a pivotal role in overseeing the financial health and strategy of the Company. The candidate will be responsible for managing the finance department, implementing financial policies, and ensuring compliance with regulations while contributing to the company's overall growth and profitability. As the Head of Process Excellence, the candidate will be responsible for driving standardization of processes across the organization, by strategically leveraging technology and optimizing processes to ensure operational efficiency, and create system based controls to build the platform for scale. In this process he will play a pivotal role ...

Looking for Quality Assurance professionals for a globally leading Pharmaceutical Client, responsible for managing all the quality related aspects at the external suppliers/ contract manufacturing sites. Key deliverables are as follows : Lead supplier qualification process Lead for Technical Meetings Assessing quality assurance agreements Single point of contact for all the quality related activities at external suppliers. Quality compliance w.r.t GMP environment, regulatory affairs, adherence to quality manual Quality Auditing, change requests, Supplier Relationship Manager Willing to travel extensively to all the contract manufacturing sites in India Ideal Background for the candidate : 10...

Johnson Controls is looking for Sr. Analyst - RTR EMEA to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

About The Role Credit Card Process Manager Marketing HO Department Credit Card Products Location Infiniti IT park Reporting Relationship Position Grade Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital / Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identificatio...

Domain Expertise Areas & Role & Responsibility: Should be able to do as follows: Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in collaboration with the worlds Top Specialty Research Hospitals for multi-centred R & D. - KOL ...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financin...

Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in collaboration with the worlds Top Specialty Research Hospitals for multi-centred R & D. - KOL Management. - Clinical Business Operations, Business Operation. - Medical Educati...

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP HCM Payroll Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-...

Medcare Hospitals Medical Centres is looking for Associate.Pharmacy to join our dynamic team and embark on a rewarding career journey The successful candidate will play a vital role in ensuring the accurate dispensing of medications, providing patient education, and collaborating with healthcare providers to optimize patient care If you have a strong foundation in pharmaceutical practices, excellent communication skills, and a commitment to patient well-being, we invite you to apply Responsibilities:Medication Dispensing:Dispense prescription medications accurately, following legal and ethical guidelines Ensure proper labeling, packaging, and documentation of dispensed medications Verify pre...

Job Description: FDA Manager Food/FMCG (15-20 yrs) Position: FDA Manager Department: International Business Timings: 12:00 Pm to 9:00 pm We are looking for a seasoned US FDA Clearance Manager with 1520 years of experience in Regulatory Affairs & Compliance for Food/FMCG, with a strong focus on the US market. Key Responsibilities: Lead all USFDA clearance, approvals & compliance processes. Ensure adherence to 21 CFR, FSMA, FSVP, labelling & packaging norms . Manage dossiers, regulatory submissions & audit inspections. Guide cross-functional teams (R&D, QA, Production, Exports). Liaise with USFDA, certification bodies, distributors & consultants. Qualification & Experience Degree in Food Tech/...

Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Manage and supervise a team of professionals to ensure efficient operations. Analyze operational data to identify areas for improvement and optimize processes. Coordinate with various departments to ensure seamless operations and resolve issues. Implement and maintain quality control measures to ensure high standards. Identify and mitigate risks to ensure compliance with regulatory requirements. Job Requirements Proven experience in operations management with a minimum of 5 years of experience. Strong knowledge of operational principles and practices. Excellent leadership, communication, and...

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintains state and federal licenses for Amgen products across phases of development, modality, and countries, The team member will be responsible for maintaining U S state and federal commerc...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities, Key Activities Contributes to product teams and acts as product lead or pr...

Experience in Regulatory affairs. Exp in CMC and Labeling. Location: Bachupally, Hyderabad.

Role Overview As a Senior Healthcare IT Consultant, you will leverage deep industry knowledge to advise healthcare organizations on technology transformation, process optimization and digital innovation. You will drive presales, business development, and the execution of large-scale healthcare IT projects across multiple geographies. Key Responsibilities Client Advisory & Strategic Consulting Partner with senior stakeholders to assess needs, design IT strategies, and deliver tailored solutions spanning health care sector. Guide clients on emerging trends such as AI in healthcare Lead large-scale change management and digital transformation initiatives, from concept to execution. Project Exec...

KEY JOB REQUIREMENTS: In this role, you will be successful, if you have: Qualification • Bachelor or Master of Science, preferably: Biomedical, Mechanical Engineering, Biotechnology, Biochemistry, Pharmacy or similar Experience: • At least 3 to 5 years of experience including experience in leading teams and managing daily operations, preferably in complaint management • Experience in complaint database such as SAP, Trackwise, Salesforce etc. • Holds knowledge of monitoring and tracking of report submission in accordance with related standards, regulatory timelines • Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint) Key Responsibilities • Medical devices Complaint handling- C...