Regulatory Affairs Specialist
2 days ago
About the Role
This is an exciting opportunity to join our team as a Regulatory Affairs Specialist in the pharmaceutical industry. As a key member of our regulatory department, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining product registrations across various regions.
Responsibilities include:
- Working closely with cross-functional teams to develop and implement regulatory strategies for new product registrations and life-cycle management.
- Compiling and submitting high-quality documents to regulatory authorities, including license renewals, annual registrations, and notifications.
- Managing product registration dossiers, tracking outstanding documentation, and notifying relevant stakeholders in a timely manner.
- Collaborating with global, European, and third-party business partners to acquire relevant documents and information for product dossiers.
Key Skills and Qualifications
To succeed in this role, you will require:
- A Bachelor's degree in Pharmacy or Life Sciences or a relevant field.
- At least 1 year of experience in regulatory affairs, quality, or product development in the pharmaceutical or medical device industry.
- Strong knowledge of registration and regulatory requirements in Europe and North America.
- Excellent digital literacy, including proficiency in Google Suite, electronic databases, eCTD software, MS Office applications, Adobe Acrobat Standard or Professional, SAP, DMS, and Authority Regulatory databases and portals.
- Excellent communication skills, both written and verbal.
What We Offer
We offer a competitive salary of ₹8,00,000 per annum, based on your qualifications and experience. You will also enjoy a range of benefits, including professional growth opportunities, a dynamic work environment, and a chance to work with a talented team.
Join Lifelancer
Lifelancer is a talent-hiring platform that connects professionals with opportunities in the Life Sciences, Pharma, and IT domains. By joining our team, you will be part of a collaborative and innovative work environment that fosters growth and development.
-
Regulatory Affairs Specialist
1 week 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 Specialist
1 month ago
Mumbai, Maharashtra, India SUN PHARMA Full timeJob Title: Regulatory Affairs SpecialistKey Responsibilities:Ensure compliance with regulatory requirements for API Plant operations.Manage DMF compilation and lifecycle management.Coordinate change control and related submissions.Develop and maintain quality standards.Requirements:Qualifications:Minimum 2 years of experience in regulatory affairs or quality...
-
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...
-
Regulatory Affairs Specialist
1 month ago
Mumbai, Maharashtra, India Piramal Group Full timeBusiness: Piramal Pharma Solutions Department: Corporate Regulatory Affairs Job OverviewWe are seeking a skilled Regulatory Affairs Specialist to join our Corporate Regulatory Affairs team at Piramal Pharma Solutions. In this role, you will be responsible for submitting regulatory dossiers for targeted markets as per business needs to support CDMO and Agile...
-
Regulatory Affairs Specialist
6 days ago
Mumbai, Maharashtra, India Lifelancer Full timeJob TitleRegulatory Affairs SpecialistAbout the JobLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We are seeking an experienced Regulatory Affairs Specialist to join our team.Salary and BenefitsThe estimated salary for this role is $120,000 per year, taking into account the location of Mumbai, Maharashtra, India, and the required...
-
Senior Regulatory Affairs Specialist
1 week ago
Mumbai, Maharashtra, India Vision Achievement Full timeVision AchievementWe are seeking a highly experienced and skilled Senior Regulatory Affairs Specialist to join our team at Vision Achievement. This is an exciting opportunity for professionals who have a passion for patient safety and population health improvement.About the Role:As a Senior Regulatory Affairs Specialist, you will be responsible for planning...
-
Regulatory Affairs Specialist Lead
2 days ago
Mumbai, Maharashtra, India Inventia Healthcare Limited Full timeAbout the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team at Inventia Healthcare Limited. This role requires strong communication skills, attention to detail, and the ability to collaborate with various departments to achieve successful submissions.
-
Regulatory Affairs Specialist
1 week ago
Mumbai, Maharashtra, India Lifelancer Full time**Overview of Regulatory Affairs Role in Life Sciences**Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma, and IT, is seeking an experienced Regulatory Affairs Specialist to join our team. This role plays a critical part in ensuring compliance with regulatory requirements for product registration, maintenance, and advocacy.The ideal...
-
Regulatory Affairs Specialist
2 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
1 month ago
Mumbai, Maharashtra, India Parexel Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Consultant to join our team at Parexel.As a Regulatory Affairs Consultant, you will be responsible for handling the life cycle management of approved drug products, including tablets, syrups, and parenterals.You will lead and contribute to the planning, preparation, and delivery of regulatory...
-
Regulatory Affairs Specialist
1 week 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...
-
Mumbai, Maharashtra, India Parexel Full timeAbout this RoleParexel is seeking a highly skilled Senior Regulatory Affairs Associate to join our team in a labeling specialist role. This individual will be responsible for ensuring compliance with key labeling regulations and guidelines.Key ResponsibilitiesCollaborate with cross-functional teams to ensure accurate and compliant labeling.Develop and...
-
Medical Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Piramal Group Full timeAbout the Role:The Medical Regulatory Affairs Specialist will play a crucial role in providing scientific inputs for new product development, reviewing and approving product claims, conducting claim substantiating studies, conducting scientific training for marketing teams, responding to medical & regulatory queries, provide scientific support for consumer...
-
Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Piramal Group Full timePiramal Pharma Solutions Department: Corporate Regulatory Affairs Job Overview: We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Kurla. The successful candidate will be responsible for the submission of regulatory dossiers for targeted markets, ensuring compliance with CDMO and Agile businesses. Key Stakeholders: Sites –...
-
Regulatory Affairs Associate
4 weeks ago
Mumbai, Maharashtra, India Colgate-Palmolive Company Full timeColgate-Palmolive is seeking a skilled Regulatory Affairs Associate to join our team. In this role, you will be responsible for handling and maintaining product compliance during the entire product life-cycle.Key Responsibilities:Work closely with the Regional Regulatory Affairs Department to ensure compliance with regulatory requirements.Support the...
-
Regulatory Affairs Specialist
3 weeks ago
Navi Mumbai, Maharashtra, India IF MedTech Pvt Ltd Full timeIF MedTech Pvt Ltd is revolutionizing healthcare through cutting-edge medical device design, development, and pilot manufacturing. Our global team collaborates with experts across medical, engineering, business, and research domains to bring innovative solutions that enhance healthcare and improve lives.We are seeking a skilled Regulatory Affairs Specialist...
-
Regulatory Affairs Director
4 days 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 Professional
3 weeks ago
Mumbai, Maharashtra, India Ashish Life Science Pvt Limited Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ashish Life Science Pvt. Limited.Key ResponsibilitiesEnsure timely submission of regulatory dossiers, including ANDAs, NDAs, CTDs, and other product approvals.Coordinate with R&D, Quality Assurance, and Manufacturing teams to gather necessary documentation for...
-
Global Regulatory Affairs Specialist
3 weeks ago
Mumbai, Maharashtra, India Archroma Full timeArchroma OverviewThe Product Stewardship Organisation is seeking a highly skilled and motivated individual to join our team as a Global Regulatory Affairs Specialist.About the RoleWe are looking for a proactive and experienced professional to ensure the marketability of our products in a cost-efficient manner across regulated countries, specifically in EMEA....
-
Clinical Trials Specialist
2 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeCompany OverviewLifelancer is a leading talent-hiring platform in the Life Sciences, Pharma, and IT sectors. We connect professionals with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.About UsWe are committed to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and...