Walk in Drive API Regulatory Affairs Dept
19 hours ago
Role & responsibilities
Walk In Drive for API Regulatory Affairs Dept (RA) @ R&D Center
Work Location :- MSN Laboratories Pvt. Ltd.
MSN R&D center, Pashamylaram, Isnapur, Patancheru, Sangareddy
Interview Date: @Saturday & @Sunday
Interview Time :- 9AM TO 5PM
Venue Details :
Quality Inn Ramachandra
Ward No- 58, 31-41/10/1, Duvvada, Revenue, Visakhapatnam, Andhra Pradesh 530046
Contact :
Regulatory Affairs Specialist to join our API Division.
This role is critical to ensuring compliance with regulatory requirements for our active pharmaceutical ingredients (APIs).
The ideal candidate should have 1-7 years of regulatory affairs experience in the pharmaceutical industry.
Key Responsibilities:
Regulatory Submissions: Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations.
Documentation Management: Maintain, review, and update regulatory documentation, including drug master files (DMFs) and technical files, to support product registrations and renewals.
Compliance Assurance: Stay up-to-date with regulatory changes, assess the impact on products, and provide recommendations for maintaining compliance.
Communication: Interact with regulatory authorities, addressing inquiries, requests, and managing inspections and audits as required.
Cross-functional Collaboration: Work closely with internal teams, including R&D, quality assurance, and production, to provide regulatory guidance and support for API-related activities.
Quality Standards: Ensure that API products meet quality and safety standards in alignment with Good Manufacturing Practices (GMP) and other relevant quality regulations.
Regulatory Strategy: Contribute to the development of regulatory strategies for product development and lifecycle management.
Position : Executive/Sr Executive
Qualification : M.sc
Work Location : MSN R&D Center, Pashamylaram.
Department : API Regulatory Affairs Dept - ( API RA )
Experience : 1 to 7 Years
Job Location :
MSN Laboratories Pvt.Ltd.,
MSN R&D center, Pashamylaram, Isnapur, Patancheru,Sangareddy
Venue Details : Quality Inn Ramachandra,Ward No- 58, 31-41/10/1, Duvvada, Revenue, Visakhapatnam, Andhra Pradesh 530046
Interested Candidates can share there CVs to
-
Regulatory Affairs Manager
1 week ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 1,20,000 - ₹ 2,40,000 per yearJob Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a...
-
Executive Regulatory Affairs
4 days ago
Hyderabad, Telangana, India Jodas Expoim Full time ₹ 5,00,000 - ₹ 12,00,000 per yearJob Title: Regulatory Affairs ExecutiveDepartment: Regulatory AffairsLocation: HyderabadExperience: 1-5 YearsIndustry: Pharmaceuticals (Injectables / OSD)About Jodas ExpoimJodas Expoim is a fast-growing, global pharmaceutical company committed to delivering high-quality, affordable medicines. We focus on complex injectables and are driven by innovation,...
-
Regulatory Affairs Manager
15 hours ago
Hyderabad, Telangana, India e0d02ddc-eb75-4e6d-9034-ffa8f67d7810 Full time ₹ 90,00,000 - ₹ 1,20,00,000 per yearAbout the Company:Shri Kartikeya Pharma is one of India's leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory AffairsExperience:8–12+ yearsof Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal...
-
Regulatory Affairs- eCTD Specialist
2 weeks ago
Hyderabad, Telangana, India Nooha Asp Full time ₹ 5,00,000 - ₹ 15,00,000 per yearRegulatory Affairs Hiring Profile eCTD SpecialistExperience Level: 3 to 6 YearsLocation: Work from office (Hyderabad)Skills & Qualifications:1.Education: Bachelor's or Masters degree in Life Sciences, Regulatory Affairs, or related field.2.Experience: 3 to 6 years of experience in regulatory affairs with a focus on eCTD submissions, preferably in the...
-
Regulatory Affairs Associate Director
1 week ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 20,00,000 - ₹ 25,00,000 per yearRole description:Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this...
-
Regulatory Affairs Manager
7 days ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per yearRegulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA...
-
Regulatory Affairs Intelligence Manager
7 days ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 12,00,000 - ₹ 36,00,000 per yearThe Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director. This role often has a technology and data focus , managing the tools and information that drive the intelligence process.Key Responsibilities:Intelligence Gathering &...
-
Regulatory Affairs- EU Market
2 weeks ago
Hyderabad, Telangana, India V3 Staffing Full time ₹ 9,00,000 - ₹ 12,00,000 per yearGreetings of the day Our reputed MNC Client is hiring for:Designation: Regulatory Affairs- EU Market- Pre & Post ApprovalLocation: HyderabadShift: GeneralWork Mode: WFO (5 days working)Interview Mode: F2F interviewNOTE: Looking for candidates from Generic Pharma and not from API as this is for formulationRole & responsibilities:Component with EU-Filing...
-
Regulatory Affairs Specialist
2 weeks ago
Hyderabad, Telangana, India Medtronic Full time ₹ 1,00,00,000 - ₹ 2,00,00,000 per yearAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeRegulatory Affairs Specialist In this exciting role as a Regulatory Affair Specialist, you will...
-
Regulatory Affairs
18 hours ago
Hyderabad, Telangana, India Shilpa Medicare Full time ₹ 5,00,000 - ₹ 15,00,000 per yearRole & responsibilitiesCMC and Labelling:Preparation of ANDAs in eCTD format for various type of formulationsReview of the technical documents such as Specifications, BMR, MFC,Able to work on All type of CTD section write-upsHands on experience on life cycle management activity (AR, CBE, CBE-30 and PAS)Through knowledge on ICH guidancesShould able to handle...