2122 Regulatory Affairs Jobs - Page 37

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into pro...

•Direct the preparation and submission of regulatory agency applications, reports, or correspondence. •Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Required Candidate profile Experience in Regulatory Affairs function with experience in preparing DMF for US / EU / Japan / ROW market and handling their queries / deficiencies.

Lead global industry marketing programs Drive and execute sponsorship & participation in industry events Develop marketing artefacts and collateral along with messaging for the website Formulate & work with Inside Sales & external vendors on demand-gen programs Support the analyst relations program & garner mentions by driving participation in relevant studies

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

The Manager/Sr. Manager Regulatory Affairs (ROW) position at Omnicals Pharma Pvt. Ltd, located in Andheri (W), Mumbai, is a full-time role suitable for candidates with a qualification in B.Pharm/M.Pharm/M.Sc in Pharmaceutical (Manufacturing/Exports/Finished Formulation Only) industry. The ideal candidate should possess a minimum of 8 to 12 years of experience in a pharmaceutical company, with a strong background in Regulatory Norms for ROW/PICs for at least 8 years. Key responsibilities include responding to queries raised by consultants and MOH of the above regions, therefore, requiring excellent command over English and communication skills. If you meet these qualifications and are interes...

As an Associate Director/Director - Compliance in Gurgaon, you will be responsible for providing secretarial and administration support at the board or senior management level. You must possess the ability to communicate confidently and effectively with internal and external stakeholders at all levels. Your exceptional organization and time management skills will be utilized for setting and meeting deadlines. Your role will require excellent verbal and written communication skills, along with a deep understanding of the provisions of the Companies Act, 2013. Your proficiency in interpreting and analyzing the Act will be essential for this position. Your responsibilities will include ensuring...

Role & responsibilities Should have In-depth knowledge of the US ANDA (Abbreviated New Drug Application) requirements, with expertise in the entire process from submission to approval. This includes familiarity with the regulatory framework for generic drug approval by the FDA, the preparation and review of bioequivalence studies, drug master file (DMF) submissions, labeling requirements, and the integration of Good Manufacturing Practices (GMP) into product development. Proficient in managing US post-approval changes, including: Prior approval supplements (PAS): Expertise in preparing and submitting PAS for significant changes that require FDA approval before implementation. Changes Being E...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Original Application submission Labeling development for original applications (NDA/ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve outs based on patents and exclusivity claims Labeling Query responses/ REMS and Patent Amendments/ PNP Requests Thorough review/interpretation of FDA comments. Review of revised labeling and response. Tracking/ Review for Completeness/ Timely Submission of REMS correspondence/ Amendments Review of patent amendment & proprietary name review request Submission of Final Approval Requested Life Cycle Management Track RLD labeling changes Initiate labeling revision activity as per RLD label revision/safety labeling change SLC notification fr...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, exper...

Work Flexibility: Hybrid What you will do Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource. Usually works with minimum supervision having some latitude for in...

KEY RESPONSIBILITIES: • Ensure compliance with SEBI, stock exchange, and other regulatory guidelines. • Manage audits, inspections, and regulatory reporting. • Develop and update compliance policies and SOPs. • Liaise with internal teams to address compliance gaps. • Drive employee awareness and training on compliance matters. SKILLS REQUIRED: • In depth knowledge of SEBI regulations, AML guidelines, and PMLA provisions. • Strong analytical, documentation, and communication skills. • Proactive and detail - oriented with high ethical standards.

Roles and Responsibilities Manage ANDAs (Abbreviated New Drug Applications) for US market approval. Prepare DMFs (Dossier Management Facility) for regulatory submissions. Ensure compliance with FDA regulations and guidelines throughout product lifecycle management. Collaborate with cross-functional teams to develop formulations that meet regulatory requirements. Provide expertise on drug regulatory affairs, including labeling, claims, and risk assessment. Desired Candidate Profile M.Pharma degree from a recognized institution. Minimum 15-24 years of experience in Regulatory Affairs - Formulations. Strong understanding of FDA regulations and guidelines. Excellent communication skills for effe...

The role will drive regulatory approvals, product certifications, patent rights, and filing processes, while ensuring the organization remains fully aligned with global industry and safety regulations. Required Candidate profile Qualified: Graduate in Electronics or Electrical Engineering with 7+ yrs is preferred. Experience in consumer/industrial/automotive electronics or IoT products.

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The m...

Maintain H1B petitions including annual H-1B CAP, extensions of current visas and transfer petitions for new employees. Prepare in-house documents and petitions for other visas including but not limited to F-1, L1, and dependent visas (H4, L2 etc). Have ability to lead immigration process from start to finish, working with non-immigrant & immigrant Visa applications and processes (H1-B, H-4, L-1, TN, and EB non-immigrant petitions, RFE, etc.), EAD renewals of employees and dependents. Maintain Public Access Files ensuring compliance, documentation and execution of immigration policies and procedures. Experience of handling FDNS site visits, PAF, DOL audits. Consultation: Assessing employees ...

As an Associate Director/Director - Compliance based in Gurgaon, you will be responsible for providing secretarial and administration support at board or senior management level. Your role will involve effective communication with internal and external stakeholders, ensuring strict adherence to statutory and regulatory requirements under the Companies Act, 2013. Your excellent organization and time management skills will be crucial in setting and meeting deadlines. You will be required to prepare and file all statutory forms, returns, and documents with the Registrar of Companies and other regulatory bodies accurately and timely. Additionally, you will need to maintain statutory registers, m...