Regulatory Compliance Specialist
2 weeks ago
Regulatory Affairs ProfessionalThis is a highly skilled role that requires strong knowledge of regulatory frameworks and compliance procedures. The Regulatory Affairs Executive plays a critical part in ensuring the company adheres to all applicable laws and regulations.Key responsibilities include preparing and reviewing electronic Common Technical Document (eCTD) dossiers for submissions, coordinating with cross-functional teams, and submitting applications to regulatory authorities. To be successful in this position, you will need to have a solid understanding of dossier structure, eCTD publishing, and submission timelines.The ideal candidate will possess excellent communication skills, both written and verbal, as well as the ability to work effectively in a team environment. Strong analytical and problem-solving skills are also essential in this role, as you will be required to troubleshoot validation issues before final submission. Additionally, you will need to stay up-to-date with changes in FDA, EMA, and ICH guidelines.Maintaining accurate records of regulatory databases, submission trackers, and approval records is also a key aspect of this role. You will be working closely with internal departments to ensure the smooth progression of submissions and post-approval changes.Preparation and review of eCTD dossiers for submissionsCoordinating with cross-functional teamsSubmission of applications to regulatory authoritiesCompilation and validation of submissions using tools like Extedo or Lorenz docuBridgeEnsuring completeness and accuracy of eCTD sequencesTroubleshooting validation issues before final submissionManagement of post-approval changesRequirementsBachelor's degree in a relevant field such as Life Sciences, Pharmacy, or related disciplineProven experience in Regulatory Affairs or a related fieldStrong knowledge of regulatory frameworks and compliance proceduresExcellent communication and teamwork skillsAbility to analyze complex data and make informed decisionsBenefitsThis is an excellent opportunity to join a dynamic team and contribute to the success of the company. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
-
Regulatory Compliance Officer
1 week ago
ahmedabad, India beBeeCompliance Full timeEntity Compliance Specialist: Key Responsibilities and RequirementsAbout the RoleThe position of Entity Compliance Specialist is a critical component of our organization's efforts to ensure regulatory compliance. This role involves providing expert advice on compliance matters, conducting regular audits and reviews to identify risks, developing policies and...
-
Compliance Specialist
1 hour ago
Ahmedabad, Gujarat, India Uncore Digital Full timeCompany DescriptionUncore Digital is dedicated to redefining the digital experience by helping businesses thrive in a digital-first world. Specializing in Digital Services, Digital Products, and Digital Transformation, Uncore Digital offers solutions like digital marketing, website development, automation, and SEO optimization to empower brands and...
-
Regulatory Medical Content Specialist
5 days ago
ahmedabad, India beBeeMedical Full timeJob Title:Regulatory Medical Content SpecialistDescription:We are seeking a skilled Regulatory Medical Content Specialist to draft, review, and finalize regulatory documents. As a key member of our team, you will perform literature reviews, adhere to regulatory guidelines, collaborate with cross-functional teams, and ensure the accuracy and quality of...
-
Regulatory Specialist:Pharma OSD(DRA)
1 week ago
Ahmedabad, Gujarat, India Lezivia Lifesciences Full time ₹ 4,00,000 - ₹ 10,00,000 per yearCompany DescriptionLezivia Lifesciences is a distinguished pharmaceutical company renowned for its commitment to quality and excellence. Most of its products are manufactured in WHO-approved facilities, ensuring the delivery of superior healthcare solutions to patients. Lezivia has built a strong reputation within the industry for its dedication to providing...
-
Senior Compliance Specialist
2 weeks ago
ahmedabad, India beBeeRegulatory Full timeCompliance Manager RoleMaintaining registration and licensing in India ensures the organization adheres to regulatory reporting obligations.Furnish compliance support across business units in India.Implement controls over Know Your Customer (KYC) and Anti-Money Laundering (AML) matters, policies, procedures, and best market practices within cryptocurrency...
-
Regulatory Affairs
22 hours ago
Ahmedabad, India Lendex Technology Full timeResponsibilities : Dossier Preparation : Compile, review, and prepare regulatory documentation, ensuring accuracy and completeness. Collaborate with cross-functional teams to gather necessary information for dossier submissions. Maintain and update regulatory files and databases. DMF Management: Manage Drug Master Files (DMFs) and ensure timely submissions...
-
Ahmedabad, India MJ Surgical Full timeWe are Hiring Regulatory Affairs Specialist For Medical Devices (Orthopedic Implants And Instruments) Role & Responsibilities: 1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA. 2. Work On Technical Master File. 3. Work On CERs (Clinical Evaluation Report) As Per EU MDR. 4. Work on Design & Development and Risk Management Files as...
-
Ahmedabad, India MJ Surgical Full timeWe are Hiring Regulatory Affairs Specialist For Medical Devices (Orthopedic Implants And Instruments) Role & Responsibilities: 1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA. 2. Work On Technical Master File. 3. Work On CERs (Clinical Evaluation Report) As Per EU MDR. 4. Work on Design & Development and Risk Management Files as...
-
Ahmedabad, India MJ Surgical Full timeWe are Hiring Regulatory Affairs Specialist For Medical Devices (Orthopedic Implants And Instruments) Role & Responsibilities: 1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA. 2. Work On Technical Master File. 3. Work On CERs (Clinical Evaluation Report) As Per EU MDR. 4. Work on Design & Development and Risk Management Files as...
-
Regulatory Affairs
6 days ago
Ahmedabad, Gujarat, India VHA Biopharma Private Limited Full timeCompany DescriptionJaidev Pharma Placement is a renowned recruitment agency with a proven track record of over two decades in Pharmaceutical Sales, hiring, recruitment, and training across India. We specialize in providing tailored human resources solutions to help organizations achieve their goals while supporting employees' career growth. Our expertise...
