Manager - Regulatory Affairs
1 month ago
The individual will be involved in CMC document review, follow up with all stake holders to achieve quality submissions in timely manner. The individual will thus closely work with the development, quality and plant teams. This individual will also prepare all CMC regulatory documents and coordinate to keep CMC RA database in most updated manner.
What are the key responsibility of the role?Individual contributor for authoring of CMC sections for IND / IMPD / NDA (CRL resubmission) packages and their life cycle management.Support in developing and executing the overall regulatory CMC strategies for each supported program as applicable.Authoring CMC sections for meeting requests / briefing packages for scientific advice meetings.CMC gap assessment, develop mitigation plan and ensure implementation strategy.Facilitate and lead all communications with regulatory agencies / health authorities / consultants / internal stake holders, as applicable for CMC related aspects.Participate in various stage gate meetings for the assigned programs.Set and monitor submission timelines along with other key stakeholders.Conduct departmental and cross functional level trainings, as necessary.Should have sound knowledge of various clinical phases and respective CMC requirements.Stay abreast of regulatory agency regulations, directives, guidelines and policies etc that could have an impact on product development to assess approval pathways and issues.
Job requirements:Educational Qualification - M. Pharm / MScGood understanding of R&D processes, technology transfer and other CMC topics for API and drug product. Experience of
sterile dosage forms
is must. The ability to manage competing priorities.Good communication, presentation skills.
-
Regulatory affairs manager
3 weeks ago
Mumbai, India G&L Healthcare Advisors Full timeG&L Healthcare Advisors is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance consultancy work – and we are rapidly growing! Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements...
-
Regulatory Affairs Manager
3 weeks ago
Mumbai, India G&L Healthcare Advisors Full timeG&L Healthcare Advisors is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance consultancy work – and we are rapidly growing! Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements...
-
Regulatory Affairs Executive
6 months ago
Mumbai, India Morpheus Human Consulting Full timeReference Code: - 319-58 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Job Title: Regulatory Affairs Executive - Vile Parle - Mumbai - **Job Description**: - Managing regulatory affairs of the organization & its subsidiaries / associates. - Liaising with regulatory bodies like...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer in Mumbai, India. As a key member of our Regulatory Operations department, you will be responsible for ensuring compliance with regulatory requirements across various product categories.The ideal candidate will have a BS degree in Pharmacy or Life Sciences and 1+...
-
Regulatory Affairs Director
1 week ago
Mumbai, Maharashtra, India Lifelancer Full timeAbout LifelancerLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.Salary InformationThe estimated annual salary for this role is ₹1,500,000 - ₹2,250,000.Job DescriptionThis experienced professional will work under limited supervision to apply subject matter knowledge in the area of Regulatory Affairs.Direct development of product...
-
Regulatory Affairs Executive
6 months ago
Mumbai, India AMPLE LEAP COGNITION & TECHNOLOGIES PVT LTD Full time**Job Description Form** **Fields** **Required Information** **Job Title** **Executive - Agriculture Regulatory Affairs** Reports To Manager Position Type New position Location Marol, Mumbai Job Overview Planning, undertaking, and overseeing regulatory work for local & export related products in Agri and Scientific support Responsibilities and...
-
Executive Regulatory Affairs
6 months ago
Mumbai, India Ample Leap Cognition & Technologies Pvt Ltd Full time**Job Description Form** **Fields** **Required Information** **Job Title** **Executive - Agriculture Regulatory Affairs** Reports To Manager CTC Budget 3-4 LPA Position Type New position Location Marol, Mumbai Job Overview Planning, undertaking, and overseeing regulatory work for local & export related products in Agri and Scientific...
-
Regulatory Affairs Manager
1 month ago
Mumbai, India Abbott Full timeExperienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. •As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed...
-
Regulatory Affairs Officer
4 months ago
Mumbai, Maharashtra, India TheTalentforte.com Full timeManufacturer of Bio-Pharmaceuticals, Soft Gel Capsules & Multi-Vitamins **REGULATORY AFFAIRS** Job Location: Borivali West **Experience: Min. 2 years in Pharma Formulations** - Conduct quality assurance activities to ensure compliance with regulatory requirements. - Manage regulatory audits by providing necessary documentation and support. - Maintain...
-
Regulatory Affairs Manager
7 days ago
Mumbai, India Zeon Lifesciences Ltd Full timeThe Regulatory Manager will be responsible for overseeing and ensuring that all food compliance mandates related to FSSAI and AYUSH formulation guidelines are strictly adhered to. This includes managing compliance for Zeon's domestic product range, which covers Proprietary Foods, Nutraceuticals, Health Supplements, Food for Special Dietary Users (FSDU), Food...
-
Regulatory Affairs Executive
6 months ago
Mumbai, Maharashtra, India Fusion Market Research Full timeRegulatory affairs officers ensure that products such as foods, cosmetics, pharmaceuticals and veterinary medicines - and the steps involved in developing, testing and marketing them - meet legislative requirements. **Typical duties include**: - studying scientific and legal documents to check they meet legal requirements. - gathering, evaluating,...
-
Regulatory Affairs Professional
2 weeks ago
Mumbai, Maharashtra, India Chemill Pharma Ltd. Full timeAt Chemill Pharma Ltd., we are seeking an experienced Regulatory Affairs Manager to join our dynamic team. This pivotal role involves ensuring timely regulatory submissions, close coordination with manufacturers, and meticulous document management.Detailed Responsibilities:Review and evaluate assigned dossiers from manufacturers according to country-specific...
-
Regulatory Affairs Specialist
7 days ago
Mumbai, Maharashtra, India Lifelancer Full timeEstablished in Vikhroli West, Lifelancer is a leading talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, and IT domains.We are seeking a highly motivated Regulatory Affairs Trainee to join our team. As a Regulatory Affairs Trainee, you will be responsible for preparing, compiling, and coordinating...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Chemill Pharma Ltd. Full timeChemill Pharma Ltd. is a dynamic organization seeking a seasoned Regulatory Affairs Manager to oversee the regulatory submission process. This role requires strong organizational skills and the ability to manage multiple tasks under tight deadlines.Job Summary:We are seeking an experienced Regulatory Affairs Manager to join our team in ensuring timely...
-
Regulatory Affairs Executive
6 months ago
Andheri East, Mumbai, Maharashtra, India Career Strategy Solutions Full timeSeeking Drug Regulatory Affairs for a Company into Pharma Industry **Key Responsibilities**: - Research and stay updated on regulatory requirements and guidelines - Coordinate with cross-functional teams to gather necessary documentation and information for regulatory filings - Review and assess product labeling, packaging, and promotional materials to...
-
Associate, Regulatory Affairs
6 months ago
Mumbai, India Colgate-Palmolive Full timeRelocation Assistance Offered Within Country 156756 - Mumbai, Maharashtra, India **Who We Are** Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries...
-
Regulatory Affairs Strategist
3 weeks ago
Mumbai, Maharashtra, India Abbott Full timeJob Summary">We are seeking an Experienced Regulatory Affairs Manager to join our team at Abbott.About the Role">This is an individual contributor role that works under limited supervision and applies subject matter knowledge in the area of Regulatory Affairs.The ideal candidate will possess well-developed skills in directing development of product...
-
Associate, Regulatory Affairs
1 month ago
Mumbai, Maharashtra, India Colgate-Palmolive Full timeRelocation Assistance Offered Within Country Job Number #163733 - Mumbai, Maharashtra, India **Who We Are** Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the...
-
Regulatory Affairs Associate
6 months ago
Goregaon, Mumbai, Maharashtra, India Zivira Labs Private Limited Full time_**Regulatory Affairs Associate**_ As regulatory affairs associate you'll be the crucial link between the company, its products and regulatory authorities. You'll combine your knowledge of scientific, legal and business issues to ensure products, which are developed or manufactured, meet the required legislation. **Products include**: - Pharmaceuticals -...
-
Mumbai, Maharashtra, India OMC Medical Limited Full timeCompany OverviewOMC Medical Limited is a healthcare company based in the UK, specializing in UK MHRA Registration, European Authorized Representation, global product registrations, and other regulatory services.Salary £40,000 - £60,000 per annum, depending on experience.Job DescriptionThis is a full-time, remote-based role for a Regulatory Affairs Human...