Regulatory Affairs Compliance Specialist

Regulatory Affairs Specialist - CMCKey Responsibilities:Lead and manage submissions for USFDA compliance, ensuring timely preparation, review, and filing of regulatory documents.Oversee compilation and submission of reports, amendments, and deficiency responses to regulatory agencies.Collaborate with cross-functional teams to gather required documentation...

Regulatory Affairs Expert We are seeking a seasoned professional to manage our legal and regulatory affairs. The successful candidate will be responsible for providing expert advice on commercial agreements, contract negotiation, and compliance with relevant regulations. Key Responsibilities: Advise on commercial agreements, including third-party contracts,...

Key Responsibilities:Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.Review...

We are seeking a highly skilled professional to join our client in the Medical Device Industry.Job Description:Quality Assurance and Regulatory AffairsEnsure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.Coordinate with regulatory authorities for obtaining required permissions and approvals.Oversee risk management, clinical evaluation,...

Compliance Specialist - BIS CertificationWe are seeking a skilled Compliance Specialist to assist our clients in obtaining the ISI Mark Scheme certification under the Bureau of Indian Standards (BIS). The specialist will play a key role in ensuring compliance with BIS standards for manufacturers and importers of products.Our goal is to help clients navigate...

Business Compliance SpecialistKey Responsibilities:Assist clients with business entity formations, including LLCs, corporations, partnerships and sole proprietorships.Manage federal business registrations, including obtaining Employer Identification Numbers (EIN), IRS filings, and compliance.Conduct state-specific registrations, including sales tax,...

Job Overview:This role requires a professional with experience in ensuring compliance and liaison with regulatory bodies, effective communication between departments and thorough understanding of local authorities to drive smooth plant operations.Key Responsibilities:Evaluate and maintain manufacturing plant compliance with local, state and federal...

Compliance Leadership RoleWe seek a seasoned professional to fill this Compliance Leadership position. The ideal candidate will have extensive experience in compliance and corporate governance, adhering to all relevant laws and regulations.Main Responsibilities:Advise the board of directors on corporate governance matters, ensuring efficient...

Job Title: Compliance SpecialistAbout the Role:This is an exciting opportunity to join our team as a Compliance Specialist. In this role, you will be responsible for ensuring that our organization complies with all applicable statutory, regulatory, and internal governance requirements.Key Responsibilities:Compliance Audit and Reporting:Conduct comprehensive...

Job Title: Legal Compliance SpecialistWe are seeking a highly skilled Legal Compliance Specialist to join our team. As a key member of our legal department, you will play a crucial role in ensuring the company's adherence to regulatory requirements and maintaining required compliance standards.The successful candidate will work closely with senior legal...