Associate Regulatory Manager
2 days ago
The Associate Regulatory Manager oversees and coordinates regulatory activities related to clinical research studies, including quality control and oversight.
DUTIES & RESPONSIBILITIES
Maintain a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols. Oversee the preparation, facilitation, and coordination of accurate and timely submission of IRB applications for protocol revisions or amendments, including changes in treatment procedures, administrative changes, subject population, funding, recruitment procedures, site changes, informed consent, or dual enrollment, as required by federal regulations and internal policy. Ensure that all documents are complete and that the submission packet meets the IRB's revision submission requirements prior to sending them to the IRB. Oversee the communications and responses to queries of the IRB, Sponsor, and other relevant stakeholders due to their review of submissions. Coordinate the review, preparation, and submission of consent forms in compliance with regulatory requirements of federal, state, and local agencies governing biomedical research. Ensure Sponsor approval of consent forms prior to submission to the IRB, if needed Facilitate and coordinate the timely and accurate submission of regulatory documents (hard copies and electronic binders) and IRB submissions by collaborating with relevant cross-functional teams to prepare regulatory documents. Ensure that regulatory binders are audited and maintained. Track workload and status of pending protocols and associated supporting documents in order to provide efficient customer service to the Research team. Participate in quality assurance (QA) and control programs related to overall project and patient data, including conducting audits and reviews, identifying, and addressing compliance issues, and implementing corrective actions as needed. Oversee QA initiatives for the department to support research staff and leaders during sponsor and FDA audits, including conducting internal audits, preparing for external audits, and addressing audit findings. Provide guidance and oversight to ensure adherence to quality control processes, including document review, process improvement, and regulatory SOP development. Collaborate with cross-functional teams, including Quality Assurance, Clinical Operations, Central Clinical Data, and Data Analytics, to ensure regulatory compliance throughout the study lifecycle. Perform any other tasks as assigned by the line manager.KNOWLEDGE & EXPERIENCE
Education:
Bachelor's degree in a related field required Master's degree, preferred.Experience:
2+ years of experience in regulatory affairs, preferably in the pharmaceutical or biomedical research industry 1+ years with regulatory software, i.e. FlorenceCredentials:
ACRP-CP or the ability to obtain one within 1 year of appointment DMCR-required training, including GCP and IATA.Knowledge and Skills:
Strong knowledge of FDA regulations, GCP/ICH guidelines, and relevant regulatory requirements. Excellent organizational skills with attention to detail. Excellent document management skills Excellent skills with descriptive processes, procedures, regulations, and guidelines Strong communication skills, both written and verbal. Ability to work independently and collaboratively in a team environment. Proficient in using electronic document management systems and other relevant software. Ability to prioritize tasks and manage multipleQualifications-
Associate Regulatory Manager
2 days ago
Karachi, Sindh, Pakistan DM Clinical Research Full timeThe Associate Regulatory Manager oversees and coordinates regulatory activities related to clinical research studies, including quality control and oversight.DUTIES & RESPONSIBILITIESMaintain a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.Oversee the preparation, facilitation,...
-
Regulatory Policy Analyst
1 week ago
Karachi, Sindh, Pakistan Simpaisa Full timeSimpaisa a global consumer fintech firm, is looking for a Regulatory Affairs Analyst who will support the Global Head of Regulatory Affairs by researching, analyzing, and tracking changes in global regulations that impact Simpaisa operations. The analyst will play a critical role in ensuring that the companys policies are up-to-date and aligned with evolving...
-
associate/manager - legal
2 days ago
Karachi, Sindh, Pakistan PerksHR Full timeJob Title: Associate / Manager – LegalLocation: Karachi, PakistanJob Type: Full-timeAbout the RoleWe are seeking an experienced and proactive Associate/Manager – Legal to join our growing team. This role will involve providing legal guidance, managing contract negotiations, and ensuring compliance across all aspects of business operations.Key...
-
Associate, Legal
2 weeks ago
Karachi, Sindh, Pakistan Ahya Full time $400,000 - $800,000 per yearCompany DescriptionAhya Technologies ("Ahya") is a sector-defining company, providing AI-powered software for the net-zero era. Ahya works at the intersection of climate science, data, and AI to help enterprises measure, analyse, reduce and report their greenhouse gas (GHG) emissions and purchase carbon offsets with accuracy, transparency and economic...
-
Product Associate
2 days ago
Karachi, Sindh, Pakistan Haball Full timeHaball's growing product team is looking to fill the role of Product Associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.Location: KarachiSalary: upto 100kResponsibilities:Translate market trends and company vision into product requirements and functional specificationsBuild processes to ensure...
-
Corporate Associate
1 week ago
Karachi, Sindh, Pakistan SANAULLAH & CO. Full timeResponsibilities:Lead and manage SECP filings, compliance documentation, and corporate record maintenance.Review and finalize company documents and correspondence with regulatory authorities.Advise and coordinate on corporate structuring, amendments, and registrations.Guide and supervise junior associates in completing assignments.Communicate directly with...
-
Business Development Associate
1 week ago
Karachi, Sindh, Pakistan METRICS RESEARCH (PRIVATE) LIMITED. Full timeCompany DescriptionMetrics Research (MR) is the first Contract Research and Site Management Organization (CRO/SMO) of Pakistan, incorporated in 2005. MR provides comprehensive research solutions for pre-clinical and clinical development services, ranging from computational systems to First-in-Human, Phase IV, and PMS aspects. With regulatory expertise,...
-
Associate Manager Mechanical
2 weeks ago
Karachi, Sindh, Pakistan Getz Pharma Full timeJob Summary:The incumbent will be responsible to conduct maintenance related activities of Blow Fill Seal (BFS) Line machine from scratch. The incumbent will be responsible to build Maintenance Team for both the sections, and will additionally be responsible to provide on time maintenance assistance & troubleshooting of all BFS Production machines in general...
-
Audit Associates
2 days ago
Karachi, Sindh, Pakistan Rao and Company Chartered Accountants Full timeCompany DescriptionRao & Company Chartered Accountants is a reputed firm offering comprehensive Assurance, Tax, and Risk Advisory services across Pakistan. With offices in Karachi, Lahore, and Rahim Yar Khan, the firm serves clients from a diverse range of industries. Committed to delivering high-quality services, Rao & Company has established a strong...
-
Assistant Manager
2 days ago
Karachi, Sindh, Pakistan SANAULLAH & CO. Full timeSanaullah & Co is hiring 01x Assistant Manager – Corporate to support and manage corporate compliance, documentation, and regulatory coordination for leading businesses across Pakistan.This role is based in Karachi and ideal for individuals, who have a strong interest in corporate governance, SECP compliance, documentation, and organizational processes and...
