Regulatory Affairs Manager
4 weeks ago
Our expertise in regulatory affairs, coupled with in-depth market analysis, ensures the success of our operations in various countries. We differentiate ourselves from competitors through quick turnaround time, excellent communication skills, efficient execution, and transparency in work.
Role DescriptionThis is a full-time on-site role as a Regulatory Affairs Manager located in Bengaluru. The Regulatory Affairs Manager will be responsible for managing regulatory compliance, understanding and implementing regulatory requirements, preparing regulatory submissions, and establishing quality systems.
Roles & Responsibilities:
KEY DELIVERABLES:To review the Dossier compiled by the RA executives IN DEPTH, and to guide them to make the necessary corrections. THE OWNERSHIP OF THE FINAL DOSSIER SUBMITTED WILL BE YOURS.To have experience of preparation of dossier of all dosage forms (Tablets/Capsules/Dry Syrups/Liquid Injectables/ Dry Powder Injections)
>To prepare and compile registration dossiers as per the CTD / ACTD guidelines> To review dossiers that are compiled by the manufacturing sites as well as other regulatory consultants and in-house RA team, and ensure maximum accuracy before submission.> To prepare & review /check artwork, pack insert, SmPC, etc.> To study Regulatory guidelines of assigned countries and to prepare a checklist / template for registration dossier.> To verify specification of excipients, active, finished product, and packaging material and all required documents.> Application, review, coordination, follow-up of legal documents COPP, FSC, etc.> Maintain a Proper database w.r.t to master document dossier.> To collect and verify all technical documents and information from various departments at the manufacturing site.> Provide Regulatory support to various departments.> Review follow-up and coordination for registration samples /WS and impurities required for analysis purposes.> To reply to any queries raised by respective regulatory authorities, in a timely manner.> To maintain and update Registration certificate /information in the regulatory database.> Monitor and set timelines for license variations and renewal approvals.> Write clear, accessible product labels and patient information leaflets.
Skills needed:
> Quality Review and In-depth review of dossiers submitted by the RA executives.> Knowledge of standards of various international regulatory bodies of South East Asia and East Africa> Organizational Skills- Work assignments, time management, working within strict time frames.> Ability to solve regulatory queries & compliance matters.> Knowledge of dossier types and filing requirements.
Requirements:> Research experience in clinical work, toxicology, pharmaceuticals, and manufacturing techniques> Prefer professionals with experience in Document (Process, Analytical) review, Dossier preparation and Submission- for ROW (Especially South East Asia and East African markets)> Minimum Five years’ of experience in Pharma Regulatory Affairs will be preferred> Immediate Joining or 15-day's Notice Period is preferred.
Candidate Profile:> B.Pharma / D.Pharma / M.Pharm with relevant regulatory Experience> Ability to grasp new concepts quickly> Good communication skills in English> Effective oral and written communication skills.> Must be flexible and capable of managing personnel> Must have a systematic approach to solving problems.> Must be able to keep calm and make quick, clear decisions while coping with pressure.> Must be able to understand the techniques and processes used> Excellent PC skills, should be proficient with the usage of the internet as a tool to find useful information.> Must be organized- timely, and with information/data.
-
Regulatory Affairs Manager
4 weeks ago
Delhi, India Medico Remedies Pvt. Ltd. Full timeCompany DescriptionMedico Remedies Ltd is a rapidly growing Finished Pharmaceutical Formulations company for tablets, capsules, external preparations focused on increasing its presence in the developing markets of the world. We are looking for competent and experienced people to join in our growth journey.Role DescriptionThis is a full-time on-site role as a...
-
Regulatory Affairs Executive
2 weeks ago
New Delhi, India Euronoxx Reserves ltd Full time**Regulatory Affairs Manager** **Benefits** JOB TYPE: Permanent EMPLOYMENT TYPE: Full-Time EXPERTISE: PHARMACEUTICAL REGULATORY AFFAIRS SALARY TYPE: Annually SALARY: Negotiable REPORTS TO: Managing Director VACATION LEAVE: paid LOCATION: Shimla, Himachal Pradesh, India. This role will be office-based or hybrid **REQUIRED: Direct experience working...
-
Regulatory Affairs Manager
1 week ago
Delhi, Delhi, India SurgeWay Biosciences Full timeCompany DescriptionSurgeWay Biosciences Pvt Ltd is an established exporter of Pharmaceutical Drugs and Niche Healthcare Products. With a strong track record of domestic and international operations spanning 40 years, SurgeWay is led by a dynamic young team that brings a professional approach and long-term business growth outlook.Our expertise in regulatory...
-
Regulatory Affairs
1 week ago
Delhi, Delhi, India People First Consultants Full timeJob:Regulatory Affairs Specialist/SeniorSpecialist/Assistant Manager Experience:1012YearsSkills:The ideal candidate would have adiploma/degree in a scientific discipline such asBiology Microbiology Pharmacy pharmacology Biotechnologyengineering or medical technology. Minimum 5years of experience in Medical devices regulatory affairs and 78years of working...
-
Drug Regulatory Affairs
2 months ago
New Delhi, India Curiza Life Sciences Full time**Job Role: International Regulatory Affairs** Responsible for compilation & submission of Dossier of a generic drug. Hand on experience in Filing dossiers to regulated, emerging and ROW markets. Experienced in CTD/ACTD and Regional Module. Experience in Filing in EU, ASEAN, MIDDLE EAST AND LATAM regions. To obtain approvals for relevant product...
-
New Delhi, India Domnic Lewis International Full timeWe are looking for a Lead Regulatory Affairs who is specialized in Indian market regulatory affairs with good connections in DCGI for a Global Pharmaceutical MNC in Delhi / BangaloreJob Description:We are looking for a Regulatory Affairs Lead to lead regulatory processes for our assigned products, ensuring swift approvals and strict compliance with...
-
New Delhi, India Domnic Lewis International Full timeWe are looking for a Lead Regulatory Affairs who is specialized in Indian market regulatory affairs with good connections in DCGI for a Global Pharmaceutical MNC in Delhi / BangaloreJob Description:We are looking for a Regulatory Affairs Lead to lead regulatory processes for our assigned products, ensuring swift approvals and strict compliance with...
-
Regulatory Affairs
2 weeks ago
New Delhi, India People First Consultants Full timeJob:Regulatory Affairs Specialist/SeniorSpecialist/Assistant Manager Experience:1012YearsSkills:The ideal candidate would have adiploma/degree in a scientific discipline such asBiology Microbiology Pharmacy pharmacology Biotechnologyengineering or medical technology. • Minimum 5years of experience in Medical devices regulatory affairs and 78years of...
-
Regulatory Affairs
3 weeks ago
New Delhi, India People First Consultants Full timeJob:Regulatory Affairs Specialist/SeniorSpecialist/Assistant Manager Experience:1012YearsSkills:The ideal candidate would have adiploma/degree in a scientific discipline such asBiology Microbiology Pharmacy pharmacology Biotechnologyengineering or medical technology. • Minimum 5years of experience in Medical devices regulatory affairs and 78years of...
-
Regulatory Affairs Specialist
1 month ago
Delhi, India Meril Full timeWe are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team. Positions are: Executive / Sr. Executive / Asst. Manager Regulatory Affairs Experience: 3 to 9 years Location: Andheri east, Mumbai Working Days: 6 days (Mon-Sat) WFO Responsibilities: 1. Dossier collation...
-
Regulatory Affairs Cdsco Executive
3 weeks ago
New Delhi, India Professional Utilities Full timeWe are currently seeking a proactive and dedicated Regulatory Affairs Specialist to join our team of business consultants. The primary responsibility of this role is to assist our clients in obtaining the necessary licenses and registrations from the Central Drugs Standard Control Organization (CDSCO) to establish and operate their pharmacy shops...
-
Regulatory Affairs Specialist
4 weeks ago
Delhi, India ProductLife Group Full time(JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:About usResponsibilitiesTo contribute to the production of client administrative documents and reports to be included in regulatory submissionsCompile, or supervise the compilation of...
-
Regulatory Affairs Specialist
3 weeks ago
Delhi, India ProductLife Group Full time(JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:About usResponsibilitiesTo contribute to the production of client administrative documents and reports to be included in regulatory submissionsCompile, or supervise the compilation of...
-
Regulatory Affairs Specialist
1 week ago
Delhi, Delhi, India Apsida Life Science Full timeRegulatory Affairs Specialist - CMC Variations/Submissions 12 month contract - Immediate start Overview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You'll be pivotal in ensuring compliance and efficiency in our regulatory processesKey Responsibilities:CMC Change Control Assessment:...
-
Regulatory Affairs Specialist
1 month ago
delhi, India Meril Full timeWe are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team.Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory AffairsExperience: 3 to 9 yearsLocation: Andheri east, MumbaiWorking Days: 6 days (Mon-Sat) - WFOResponsibilities:1. Dossier collation and...
-
Regulatory Affairs Officer
3 weeks ago
New Delhi, India Vimek Bioconcept Pvt LTd Full timeLooking for person having experience in European CE Certification - documentation of Medical Device & InVitro Diagnostics. Designation : Regulatory Affairs Executive Dealing with licensioing work with CDSCO, ICMR & other Govt institution Education : DPharma / MPharma / Btech for Pharma regulatory / Medical device Experiance : 2-5 Yrs Job location :...
-
Specialist,Regulatory Affairs Digitization
1 month ago
New Delhi, India ResMed Full timeThe primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory intelligence...
-
Specialist,Regulatory Affairs Digitization
2 weeks ago
new delhi, India ResMed Full timeThe primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory intelligence...
-
Specialist,Regulatory Affairs Digitization
3 weeks ago
New Delhi, India ResMed Full timeThe primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory intelligence...
-
Regulatory Affairs Specialist
4 weeks ago
delhi, India ProductLife Group Full time(JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:About usResponsibilitiesTo contribute to the production of client administrative documents and reports to be included in regulatory submissionsCompile, or supervise the compilation of...
