2122 Regulatory Affairs Jobs - Page 11

Job Title: Senior Executive /Manager 2 Regulatory Affairs Business Unit: R&D1 Regulatory Affairs Job Grade G11A/G11B Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Job Summary Regulatory submission of new p...

Role & responsibilities Hiring candidates with experience in CMC Regulatory Affairs in Pharmaceutical Industry across regulated and semi regulated regions with hands on experience into - Preparing submission content plans for CMC submissions including, post approval changes, renewals, product renewals, Module 3 baselines, and annual report/notifications. Execute regulatory team activities as directed to achieve submission approval for products in regulated and semi regulated regions. Review quality documents for post approval submissions as above. Author high quality Module 3 and Module 2 section /summaries. Maintains the general knowledge of CMC/M3 regulations and guidance for Injectables. ...

Job Title: Executive API R&D Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own SunshineAs you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Role : To execute activities related to R&D impurity synthesis, along with a ...

Regulatory Affairs Specialist POSITION PURPOSE: Responsible and accountable for all regulatory affairs activities of Bayer Pharma (PH) within assigned portfolio and/or geography. In alignment with Head of RA PH-South Asia, provide effective functional leadership and governance into planning, developing and executing regulatory strategies within assigned scope, alignment of these with business goals and plans through cross-functional collaboration enabling efficient implementation of growth, brand value Scope of regulatory activities includes all licensing related activities (including timely planning and execution of maintenance, change management) for imported products, local products and e...

Responsibilities 1. Preparation of PFD, URS, FDS, Cycle Time Analysis etc. 2. Calculation for Utilities, Peak Loads, Pipe / Pump sizing, Equipment capacity, and other accessories capacity/load/size 3. Preparation of P&ID, TS, DS, BOQ, Tender, Validation documents (VMP, FAT, IQ, OQ, PQ etc). 4. Desired exposure/ hands-on experience include: • Engineering & Consultancy Biotech & Pharmaceuticals • Process Engineers Sterile API / Formulations / Biotech Facilities • QA (Validation Experts) – Sterile API / Formulations / Biotech Facilities

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: • Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. • Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATA...

Study Coordination: Manage and oversee all aspects of clinical research studies, till the closeout. Participant Recruitment: Screen and recruit study participants Data Management: Collect, record, and maintain accurate study data and documentation. Required Candidate profile Knowledge of the pharmaceutical industry, terminology, and practices. - Knowledge of FDA regulations and their practical implementation. - Strong verbal and written communication skills.

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.

Description The Head of Medical Affairs will lead the medical strategy for our organization in India, ensuring that scientific and clinical insights inform business decisions and support our product portfolio. Responsibilities Lead the medical affairs strategy and execution for the product portfolio in India. Develop and maintain relationships with key opinion leaders (KOLs) and healthcare professionals. Oversee the medical information and communication activities for products and therapeutic areas. Ensure compliance with regulatory requirements and industry standards in all medical affairs activities. Support clinical development programs and post-marketing studies as necessary. Provide sci...

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 approval of pending r...

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 liaison throug...

The Associate Medical Director is responsible for performing medical assessment activities related to drug safety pharmacovigilance for the assigned therapeutic area(s). You will proactively evaluate safety information from individual cases and cumulative data, identify and analyze potential signals, and communicate data-driven conclusions to internal and external stakeholders. Your primary responsibilities will include performing single case medical assessment in compliance with regulations and internal guidelines, maintaining timely submission of expedited reports, supporting achievement of case processing performance timelines, identifying and evaluating safety signals, partnering with ot...

In close collaboration with the Global Program Safety Lead (GPSL), you will provide robust safety evaluation expertise and medical innovation to enhance patients" lives and influence Novartis" overall results. As a part of the Medical Safety organization, your priority will be ensuring the safety of patients, optimizing patient safety for assigned compounds, and sharing responsibility for integrating, analyzing, and evaluating internal and external safety information throughout the product lifecycle management. Your main responsibilities will include monitoring the clinical safety of projects/products, conducting medical assessments for cases, identifying safety signals, preparing safety dat...

Role & responsibilities The Regulatory Affairs (RA) & Global Registration Executive/Manager will be responsible for managing end-to-end global regulatory submissions, maintaining compliance with regional and international regulatory requirements, and facilitating timely registration and market access for medical devices across multiple geographies. Prepare and submit dossiers (510k, CE, CDSCO, etc.) as per country-specific regulations. - Maintain registration records and handle renewal processes. Monitor global regulatory updates and assess product impact. - Coordinate with QA, R&D, and marketing for data collection and documentation. - Respond to regulatory queries and deficiency letters. S...

Dear All, We are seeking a proactive and detail-oriented Regulatory Affairs professional to join our dynamic team! Role & responsibilities Preparation of CTD dossiers for Regulated manket [EU/UK/TGA]. Co-ordination with Plant, R&D & ADL to collect inputs required for Regulatory submission. Variation filling. Timely achievement of monthly plan. Interpretation and timely query response. Education - B.Pharm / M. Pharm Desired Skills Knowledge of CTD dossier preparation (EU/UK/TGA) Experience in variation filing & regulatory submissions Familiarity with ICH guidelines & compliance requirements Strong coordination & documentation skills Ability to manage timelines and regulatory queries Intereste...

Ensure manufacturing process complies with standards. Establish and update quality plans. Establish and update quality assurance procedures and specifications. Maintain and update quality assurance records. Data analysis and continual improvementComplaints handling Lead or participate in the investigation root cause determination of internal and external complaints. Initiate and implement corrective and preventive action. Document the complaint investigation, CAPA and closure of complaints. Direct and drive quality objectives. Co-ordinate with production and R&D to identify realistic and impactful quality objectives and focal for each objective. Monitor the progress of each objective and aid...

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a wide range of products and services to customers across various geographies. The business is organized into two segments: Specialty Pharmaceuticals and Generics & APIs. Specialty Pharmaceuticals segment includes Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. Generics & APIs segment comprises Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma with Research & Development units in Noida and Mysore, India. JGL operates two manufacturing facil...

You will be joining Jubilant Pharma Limited, a global integrated pharmaceutical company that offers a diverse range of products and services to customers worldwide. The business is divided into two main segments: Specialty Pharmaceuticals and Generics & APIs. Jubilant Generics (JGL), a wholly-owned subsidiary of Jubilant Pharma, has Research & Development units in Noida and Mysore, India. It operates two manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, focusing on APIs and Dosage manufacturing, respectively. The Mysore manufacturing site, spread across 69 acres, is USFDA approved and specializes in manufacturing APIs for Lifestyle driven Therapeutic Areas such as Card...

As a Technical Support Specialist at Amneal Pharmaceuticals, you will be responsible for providing end-to-end coordination for all R&D projects in a variety of areas including product initiation, API sample evaluation, product development, ANDA submission, FDA queries, ANDA approval, and launch. Your role will involve collaborating with API suppliers and internal technical teams such as Analytical, Formulation, Regulatory, and QA/QC to address technical concerns, document issues, material quality, and meet requirements for ANDA submission and regulatory agency approvals. You will utilize your technical knowledge to conduct detailed reviews of API drug master files according to current US FDA...

Job Description As an Executive at Amneal Pharmaceuticals Pvt. Ltd., located in Ahmedabad, you will be responsible for daily tasks related to the Amneal pharmaceuticals complex injectable (Microspheres) division. This full-time on-site role requires a strong background in Medicine and Medical Affairs skills, Research and Clinical Trials experience, as well as Regulatory Affairs knowledge. To excel in this role, you must possess excellent analytical and problem-solving skills, along with attention to detail and strong organizational abilities. Collaboration is key, so the ability to work effectively in a team setting is essential. Previous experience in the pharmaceutical industry is preferre...

Tracom Stock Brokers is looking for KYC Executive to join our dynamic team and embark on a rewarding career journey Maintaining accurate and up-to-date records of client information and due diligence Escalating any issues or potential risks to the appropriate parties Participating in internal and external audits, and providing relevant information and documentation as required Good knowledge of regulatory trends and developmentsProven ability to prioritize competing demands Eye for detail and willingness to question current state practices Managing requests assigned in a timely and accurate manner, contributing towards positive client experience of the end to end Candidate should have a stro...

Tracom Stock Brokers is looking for Compliance Professional to join our dynamic team and embark on a rewarding career journey Regulatory Compliance: Monitor and ensure compliance with all relevant laws, regulations, and industry standards that affect the organization Policy Development: Develop, implement, and maintain compliance policies, procedures, and programs to mitigate risks and maintain adherence to regulations Risk Assessment:Risk Analysis: Conduct risk assessments and analyze potential compliance risks, providing recommendations for risk mitigation Training and Education:Training Programs: Develop and deliver compliance training programs for employees to ensure awareness and unders...

This role will assist the AMESA Supplier Quality Assurance team by conducting re-approvals annually for low risk designated suppliers located in AMESA that supply ingredients to Pepsico. This role will contact suppliers, request, and review returned pre-requisite data and documents, and re-approve the supplier site (3-year reapproval cycle). The role will update the required database(s) to support the re-approval. The expectation is ~200 supplier sites per year. The role will also support ancillary programs in AMESA SQA such as gathering program evidence from suppliers and brokers related to Food Fraud, Quality and Food safety Certifications and Contaminants programs as well as updating the ...

Function: Corporate Relations Job Grade: G 12/G11 Manager s Job Title: General Manger Corporate Affairs Location: M ohali Function Head Title: General Manger Corporate Affairs : Areas of Responsibility At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and suppo...

Overview This role will assist the Specifications Management teams located in Mexico Business Services (MBS) or Hyderabad Business Services (HBS) to ensure exceptional service is provided in support of R&D Spec Management globally. This role will apply technical expertise and coordinate with in-market and GBS employees, as well as external resources when required, to develop clear and concise Formula, Ingredient and/or Packaging specifications, maintain existing specs and supplier relationships, and manage tracking and uploading into relevant systems. Depending on team structure, may include the opportunity to guide, mentor, check the work coming from a Spec Writer Analyst. Responsibilities ...