3208 Regulatory Affairs Jobs - Page 4

Job Description The Lead (Process Excellence) is responsible for ensuring that an organizations processes, operations, and activities adhere to regulatory guidelines, industry standards, and internal policies. Their primary focus is to establish and maintain a systematic approach to compliance & excellence with relevant laws, regulations, and best practices. This role involves overseeing and managing compliance programs, monitoring processes, and collaborating with various departments to mitigate risks and maintain a culture of integrity. Key Responsibilities Developing Strategies: Design and implement strategies for maintaining and improving process compliance across the organization. Stay ...

Overview R&D Regulatory Affairs Associate Analyst (L6) role provides: Support for PepsiCo concentrate business in India BU markets, to meet demand for compliant business-to-business beverage concentrates enabling innovation and reformulation, leading on critical regulatory compliance programmes meeting fast-paced dynamic regulatory landscape in South Asia including B2B packaging compliance, food additive/ingredient compliance, chemical notifications, classification & labelling and data approval Responsibilities Ensure regulatory compliance of all concentrate/semi-finished formulas manufactured in PGCS India and PGCS Pakistan ,Ensure regulatory compliance of all packaging materials (Primary, ...

Experience - 5+ Years Experience in Clinical SAS Programming (Inc. ADAM, TLF, CDISC Standards, Mapping & Conversion of Clinical Trial Data, Therapeautic Areas experience is must Call & What's app @prachi-8287816038

Role & responsibilities Need sound knowledge of domestic regulatory functions with ref to DBT-RCGM, CDSCO and state FDA regulations. Will prepare and submit dossier to RCGM for approval of PCT application to dept of Biotechnology Review and timebound submission of application for MAA, PAC, CT (Phase I, II and Phase III applications), Responsible for IBSC meeting conduction and related regulatory activities. Preferred candidate profile Perks and benefits

Position Details: Designation: Assistant Manager - Regulatory Affairs CMC Location: Navi Mumbai Reporting to: Deputy General Manager Job Summary: The Assistant Manager Regulatory Affairs will be responsible for managing and coordinating regulatory submissions for the US, EU, and Canadian markets, ensuring compliance with applicable regulations (FDA, EMA, Health Canada). The role involves preparing, reviewing, and submitting high-quality regulatory dossiers (NDA, ANDA, MAA, ANDS, etc.) and maintaining effective communication with health authorities/Regulatory Counterparts. Overall Job Responsibilities: 1. Regulatory Submissions Prepare, review, and submit high-quality regulatory dossiers (eCT...

We are hiring Regulatory Affairs (RA) Executive / Manager for a leading Pharma company in Ahmedabad. The candidate will be responsible for dossier preparation, product registration, regulatory submissions, and maintaining compliance with international guidelines (ROW / LATAM / Africa). Must have hands-on experience in RA documentation for pharma formulations.

Job Summary We are seeking a dynamic and experienced Formulation Scientist in Injectable division for designing and development of formulation process, ensuring quality by design (QbD) implementation, scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer. Roles & Responsibilities You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effectiveProof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injec...

You will be joining Fishfa Biogenics as an Operator for the Shift Technician/Operator department, where you will be responsible for managing operations related to Boiler, Water system, HVAC, Electrical, and Mechanical tasks. Your role will involve ensuring the smooth functioning of these systems to support the overall operations of the company. **Key Responsibilities:** - Operating and maintaining Boiler, Water system, HVAC, Electrical, and Mechanical equipment efficiently. - Conducting regular checks and inspections to ensure the systems are functioning optimally. - Responding promptly to any operational issues or breakdowns to minimize downtime. - Following safety protocols and guidelines ...

As a Drug Regulatory Affairs Manager at Covalent, your role will involve leading the Global Regulatory Project Team, managing simple and complex regulatory submissions, and ensuring compliance with core labeling documents and internal standards. Your key responsibilities will include: - Leading the Global Regulatory Project Team, comprising internal members and external partners - Planning, preparing, and delivering regulatory maintenance, divestment, and withdrawal submissions - Maintaining core labeling documents and ensuring consistency with applicable standards - Providing expert regulatory advice and leading cross-functional delivery teams - Identifying and mitigating potential regulato...

As the Director Medical AI & Innovation at Novartis, you will be a key member of the Global Medical Affairs team, leading the medical strategy for the therapeutic area. Your role will involve developing and owning Integrated Evidence Plans (IEPs), providing input into development processes, and ensuring that both US and international medical perspectives are reflected. You will be responsible for implementing medical strategies for early programs globally, focusing on innovative evidence solutions such as interventional studies, Non-Interventional Studies (NIS), Real-World Evidence (RWE) studies, and implementation science projects. Your extensive experience in drug development will enable y...

As a Compliance Executive at Fydaa Fintech Investment Advisory, your role is crucial in ensuring regulatory compliance and maintaining statutory records. This junior-level position is perfect for individuals with 1 year of experience and a Company Secretary (CS) background who aspire to develop a career in financial compliance within the dynamic fintech industry. **Key Responsibilities:** - Ensure compliance with all regulatory requirements related to SEBI, BASL, and other applicable laws - Assist in board meetings and maintain statutory records - Handle company secretarial work including ROC filings and company law compliance - Coordinate with legal advisors and external regulators as neede...

**Job Description** As an individual with experience in product development related activities for injectable dosage forms in regulated markets, you will be responsible for tasks such as preparation and review of product development reports, MFRs, stability protocols, and other study protocols and SOPs. Your knowledge should include exposure to the development of complex injectable products such as suspension-based formulations, liposomal formulations, and polymer-based products. Additionally, you should have a basic understanding of implementing QbD principles for formulation and development, including concepts like QTPP, CQA, CPP, risk assessment, and control strategy. Effective coordinati...

Roles and Responsibilities Prepare dossiers for US FDA, including CTD format. Ensure regulatory compliance with RA requirements. Manage parenteral products' dossier preparation and submission to regulatory authorities. Coordinate with cross-functional teams for injectable product development and registration. Track regulatory updates and maintain records in Trackwise system. Desired Candidate Profile 1-4 years of experience in Dossier Preparation, Regulatory Affairs (RA), or related field. M.Pharma degree from a recognized institution. Strong understanding of drug regulatory affairs, particularly in the US market (USFDA). Proficiency in preparing dossiers according to CTD format.

Handling of Documentation, Issuance and retrieval of documents,Training software Employee should have Pharmaceutical QA doc cell experience.

Work with local operating companies to provide regulatory review and approval of formulations, raw materials, and their constituent information to ensure completeness, accuracy, and compliance. Responsibilities include verification of: Trade name Manufacturer INCI name CAS/EINECS # Percentage of constituent Regional and global regulatory requirements Evaluate the potential impact to regulatory compliance and/or reporting/documentation requirements; interact with the appropriate J&J personnel. Evaluate formulations for innovation platforms, new product development, and marketed products to ensure compliance with local regulations and internal J&J standards. Prepare and compile required docume...

Overview Support Europe presentation beautification and standardization. Responsibilities Presentation Support Graphic support standard design request from BU Qualifications Applicable experience in presentation support and educational background from design.

Roles and Responsibility Develop and implement effective business strategies to achieve organizational goals. Build and maintain strong relationships with clients and stakeholders. Analyze market trends and competitor activity to identify opportunities. Collaborate with cross-functional teams to drive business growth. Identify and mitigate risks to ensure compliance with regulatory requirements. Monitor and report on key performance indicators to measure business success. Job Requirements Proven track record of achieving business objectives in a fast-paced environment. Excellent communication, leadership, and problem-solving skills. Ability to work independently and as part of a team. Strong...

Roles and Responsibility Develop and implement effective health, safety, and environmental management systems. Conduct regular audits and inspections to ensure compliance with regulatory requirements. Provide training and guidance on health, safety, and environmental procedures. Investigate incidents and accidents, and develop corrective actions plans. Collaborate with other departments to promote a culture of health, safety, and environmental awareness. Maintain accurate records and reports on health, safety, and environmental performance. Job Requirements Strong knowledge of health, safety, and environmental regulations and standards. Excellent communication and interpersonal skills. Abili...

Job Summary: We are seeking a detail-oriented and proactive Executive Regulatory Affairs to ensure compliance with all regulatory requirements related to product registration, documentation, and approvals. The role involves preparing and submitting regulatory dossiers, maintaining product licenses, and liaising with authorities to support timely market access and product lifecycle management. The ideal candidate will have strong knowledge of regulatory guidelines, documentation practices, and submission processes applicable to [pharma / medical device / FMCG] industries. Key Responsibilities: Prepare, compile, and review regulatory documents and dossiers for submission to national and intern...

Required 4 - 5yrs regulatory experience candidate with specialization in M Pharm (Pharmaceutics) Job Description Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module Well versed with Regulatory guidance and Processes (i.e., Ability to understand and interpret technical expectations during review cycle) Clear Knowledge of basic aspects of a formulation (primarily pharmaceutical development) for effective review of R&D documents. Should be aware of post approval variation requirements. Should have basic QA knowledge to enable correct review of plant related documents

RSM is looking for a dynamic Manager to join our Assurance team. You will have the opportunity to work as a team member on diverse client engagements. Our clients include local, national and internationally recognized companies. RSMs assurance professionals helping companies improve their performance through the most challenging business cycles. Responsibilities Preparing financial statements, conducting compilations and reviews, and completing Canadian corporate tax returns. Perform Review and Compilation engagements in accordance with firm and professional standards as directed by engagement leaders. Design, develop, and execute analytical procedures to assess financial data and performanc...

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

We are currently hiring for DSA I role with a minimum of 3 to 5 years Of experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Knowledge In Aggregate Reporting is Must Required Candidate profile Require 3 to 5 years of pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT)

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.