Regulatory Affairs Strategist
6 hours ago
We are seeking a highly skilled Regulatory Affairs Strategist to join our team at Naari Pharma Pvt Ltd.
About the RoleThe successful candidate will be responsible for managing the entire regulatory life cycle independently, ensuring timely and accurate submission of regulatory dossiers, and staying up-to-date with changes in regulatory policies and guidelines.
This role requires a proactive and detail-oriented approach, excellent written and verbal communication skills, and knowledge of ICH guidelines and ROW-specific regulatory pathways.
Key Responsibilities- Manage the full life cycle of regulatory submissions for ROW markets, including initial submissions, query responses, variations, renewals, and post-approval maintenance.
- Independently prepare, compile, and submit high-quality regulatory dossiers that meet country-specific requirements.
- Address regulatory queries swiftly and accurately, ensuring timely communication and resolution without delays.
- Stay current with changes in regulatory policies, guidelines, and processes, applying this knowledge to product life cycle management.
- Serve as the sole regulatory point of contact within cross-functional teams, collaborating with R&D, Quality, and Manufacturing to align regulatory strategies with business goals.
- Conduct risk assessments on regulatory strategies, identifying potential challenges and implementing proactive mitigation plans.
- Provide regulatory insights during new product development to ensure compliance with market-specific requirements.
- Maintain accurate and comprehensive documentation of regulatory activities for audits and future reviews.
- Bachelor's/M. Pharma degree with 5-9 years of relevant experience in Regulatory Affairs, focusing on ROW markets.
- In-depth knowledge of regulatory submission processes and life cycle management.
- Strong expertise in responding to complex regulatory queries and handling post-approval changes.
- A proactive, detail-oriented approach with the ability to independently manage multiple projects and deadlines.
- Excellent written and verbal communication skills.
- Knowledge of ICH guidelines, ROW-specific regulatory pathways.
$120,000 - $150,000 per annum, depending on experience and qualifications.
-
Regulatory Affairs Specialist
2 weeks ago
Gurgaon, Haryana, India Lifelancer Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT. As an Associate Regulatory Affairs Specialist, you will play a critical role in supporting the Regulatory Affairs function and systems.This is an entry-level position that requires collaboration...
-
Regulatory Affairs Specialist Gurgaon
2 days ago
Gurgaon, Haryana, India Lifelancer Full timeAre you a seasoned professional in regulatory affairs looking for a challenging role? Lifelancer is seeking a highly skilled Regulatory Affairs Specialist to join our team in Gurgaon.About the RoleThis exciting opportunity requires a strong background in CMC regulatory leadership, with experience in managing complex projects and working collaboratively with...
-
Regulatory Affairs Specialist
2 days ago
Gurgaon, Haryana, India The Hird Full timeOverviewThe Hird is seeking a detail-oriented Regulatory Affairs Specialist to join our team. In this role, you will be responsible for understanding end-to-end insurance business processes.About the RoleThis is an exciting opportunity to work with our dynamic team and contribute to the growth of The Hird. As a Regulatory Affairs Specialist, you will analyze...
-
Regulatory Affairs Leader
3 weeks ago
Gurgaon, Haryana, India Takeda Full timeJob Title:Regulatory Affairs Leader - IndiaOverview:Takeda is a pharmaceutical company dedicated to improving the lives of people around the world. We are seeking a Regulatory Affairs Leader to join our team in India. In this role, you will be responsible for leading regulatory strategies and activities to ensure compliance with local...
-
Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full timeWe are seeking a skilled Regulatory Affairs Specialist to join our team at Naari Pharma Pvt Ltd.About the RoleThis is a highly rewarding opportunity to utilize your expertise in regulatory affairs and contribute to the growth of our global presence.As a key member of our regulatory team, you will be responsible for managing the entire regulatory life cycle...
-
Regulatory Affairs Expert
3 weeks ago
Gurgaon, Haryana, India SUN PHARMA Full timeJob OverviewSun Pharma is seeking an experienced Regulatory Affairs Expert to lead our CMC Product team. In this role, you will be responsible for ensuring timely submission of annual reports and supplements to regulatory authorities.About the RoleWe are looking for a seasoned professional with 10-15 years of hands-on experience in regulatory affairs. You...
-
Medical Affairs Strategist
1 week ago
Gurgaon, Haryana, India Lilly Full timeOverviewWe are seeking a highly skilled Medical Affairs Professional to join our team at Lilly. As a key member of our organization, you will play a crucial role in delivering strategic and tactical thinking to support the development and commercialization of our products.Job DescriptionThe successful candidate will be responsible for leading medical...
-
Gurgaon, Haryana, India Lifelancer Full timeJob Title: Regulatory Affairs Manager for Global Pharmaceutical ProjectsJob Location: Gurgaon, India or other locations as neededJob Type: Full-timeSalary: ₹ 20-30 LPA based on experience and qualificationsAbout the Role:This is a challenging opportunity to lead global regulatory affairs projects for a pharmaceutical company. As a seasoned professional...
-
Regulatory Affairs Specialist
4 days ago
Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full timeJob OverviewWe are seeking an experienced Regulatory Affairs Specialist to join our team at Naari Pharma Pvt Ltd. This role involves managing the entire regulatory life cycle, ensuring compliance with market-specific requirements.
-
Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full timeJob Overview:Navigate a dynamic regulatory landscape as a skilled Regulatory Affairs Specialist with Naari Pharma Pvt Ltd. Our ideal candidate possesses an in-depth understanding of regulatory frameworks and has a proven track record of independently managing the entire regulatory life cycle.Your Key Responsibilities:Manage the full life cycle of regulatory...
-
Regulatory Affairs Manager
1 week ago
Gurgaon, Haryana, India Lifelancer Full timeWe are seeking an experienced Regulatory Affairs Manager to join our team at Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT.Job Summary:The successful candidate will be responsible for leading and developing regulatory strategies for new products, existing products, and other pipeline molecules of Takeda in accordance with applicable...
-
Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full timeCompany OverviewN aari Pharma Pvt Ltd. is a leading pharmaceutical company dedicated to delivering innovative healthcare solutions. We are committed to advancing medical science and improving patient outcomes through our cutting-edge products.About the RoleWe are seeking an experienced Regulatory Affairs Specialist to join our team in this key position. As a...
-
Regulatory Affairs Specialist
2 days ago
Gurgaon, Haryana, India Lifelancer Full timeAbout Us: Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.We're seeking a highly motivated Regulatory Affairs Specialist to support our clients' regulatory needs globally.Job Summary: As an Associate Regulatory Affairs Specialist, you will collaborate with cross-functional teams to ensure successful new product registrations and...
-
Gurgaon, Haryana, India Lifelancer Full timeAbout the Role:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Lifelancer, based in Gurugram, Haryana, India. This is a full-time position that offers a competitive salary and exciting opportunities for growth.Job Summary:The successful candidate will be responsible for driving business growth in India by providing regulatory...
-
Gurgaon, Haryana, India airtel Full timeJob SummaryWe are seeking a seasoned Senior Compliance Officer to join our Regulatory Affairs team at Airtel. In this pivotal role, you will be responsible for ensuring the company's compliance with regulatory landscape and leading our compliance monitoring program.About the Role:Regulatory Compliance LeadCompliance Program DevelopmentTraining and...
-
Compliance Specialist
6 days ago
Gurgaon, Haryana, India Savanna HR Full timeJob Title:Compliance SpecialistDescription:We are seeking a seasoned Compliance Specialist to join our team at Savanna HR in Gurgaon. As a key member of our organization, you will be responsible for ensuring timely compliance with all applicable laws and regulations in India and abroad.About the Role:This is an exciting opportunity to work with a dynamic...
-
Gurgaon, Haryana, India Lifelancer Full timeJob Description:Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best: improve the world...
-
Regulatory Affairs Specialist
2 months ago
Gurgaon, Haryana, India Siemens Healthcare Private Limited Full timeJob Summary:This role is responsible for ensuring pre-market and post-market regulatory compliance for diagnostics and medical devices in India, as well as supporting regulatory requirements in zone countries of Bangladesh, Sri Lanka, Nepal, Bhutan, and Maldives.Key Responsibilities:Interact with local marketing and global RA teams to clarify queries and...
-
Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full timeJob DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Naari Pharma Pvt Ltd. in a key role that combines regulatory expertise with market insights.About YouYou have a strong background in pharmaceutical regulatory affairs, with a proven track record of managing the entire regulatory life cycle independently.Your...
-
Regulatory Compliance Specialist
6 days ago
Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full timeNaari Pharma Pvt Ltd. is a dynamic organization seeking a highly skilled Regulatory Compliance Specialist to join our team.About the Role:We are looking for a seasoned professional with expertise in managing the entire regulatory life cycle, ensuring compliance with market-specific requirements. Your ability to manage projects end-to-end will make you a...
