Regulatory Affairs Specialist

Job DescriptionThe Senior Regulatory Affairs Specialist will lead and manage CMC regulatory activities, ensuring compliance with USFDA regulations and guidelines.This role involves overseeing compilation and submission of Annual Reports, amendments, and deficiency responses, as well as interfacing with cross-functional teams to gather required documentation...

Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs professional to lead our pharmaceutical and medical device regulatory compliance efforts.Developed, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications, ensuring timely and compliant...

About the RoleThis is a unique opportunity to join a fast-paced, dynamic team as a Data Solutions Coordinator where you will play a critical role in monitoring and analyzing the global regulatory landscape within the life sciences industry.You will support our regulatory intelligence products and services by actively participating in global monitoring,...

Key Responsibilities include Regulatory Monitoring & Implementation, Compliance Advisory & Governance, Reporting & Communication, Testing & Review, Audit & Inspection Management and Legal.This role involves tracking regulatory updates, assessing their impact on policies and business processes, and disseminating them to senior management for timely...

Job Overview:We are seeking a highly skilled Regulatory Publishing Specialist to join our team. In this role, you will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.Key Responsibilities:Compile and publish regulatory documents according to global health authority requirements.Ensure compliance with...

Job Title:Head of Corporate AffairsAbout the Role:We are seeking a highly skilled and experienced Head of Corporate Affairs to lead our company's strategic relationships with government officials, regulatory bodies, and other stakeholders.The successful candidate will be responsible for developing and implementing effective public affairs strategies that...

Strategic Policy ConsultantAbout the Role:This is a key position in navigating regulatory environments and ensuring alignment with business objectives within India's policy framework.The successful candidate will work closely with government bodies, regulatory departments, and other stakeholders to achieve business goals.Provide strategic direction and...

Job Title: Medical Affairs General ManagerThis key role leads the medical affairs strategy, focusing on providing robust medico-marketing support and facilitating collaboration between medical and marketing teams.Main Responsibilities:Provide medical references and data to support product positioning and new product research and development (NPD).Support the...

We are seeking a seasoned professional to assume the role of Medical Device Quality Assurance Leader. This is an exciting opportunity for an executive with expertise in quality assurance and regulatory affairs.The successful candidate will play a critical role in ensuring compliance with international quality standards and regulatory requirements.Main...

Job TitleA highly skilled professional is sought to manage the pharmacovigilance function. Key responsibilities include organizing and maintaining a compliant PV system, ensuring adherence to local and global processes, national and international regulations, and guidelines.The ideal candidate will have in-depth knowledge of national/regional regulatory...