84 Regulatory Submissions Jobs - Page 4

DRA Manager Experience- 15+ years Salary Package- 13-17 LPA Must have experience in regulatory Countries dossier preparation and working Should have worked in Injectable Unit location- Baddi Himachal Pradesh

Role & responsibilities: Prepare and manage regulatory submissions (e.g., Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), marketing authorization submissions). Ensure clinical trials are conducted in compliance with regulatory requirements, including Good Clinical Practice (GCP), ICH guidelines, and local regulations. Track regulatory timelines and manage submission deadlines for new drug applications, clinical trials, and so on. Preparation and review of clinical study reports along with preparation of Bio summary/summary tables, BTIF and other regulatory documents with the study data. Adhering to GCP to meet regulatory requirements, Verification of deviations from the Protocol, SOPs, GCP and other applicable requirements and taking preventive action and corrective action to prevent recurrence. Preparation of audit reports and suitable corrective and preventive action plans. To have experience in the Ethics Committee related activities. To liaison with Local Drug Authorities (DCGI/CDSCO) for regulatory approvals of Test Licenses, Amendments, for conducting BA/BE clinical studies in India. Timely notification to DCGI/CDSCO for study related updates Communicate with regulatory agencies to clarify requirements and resolve issues related to clinical trial approvals and submissions. Manage responses to regulatory queries and facilitate interactions between the client and regulatory bodies. To search literature on healthy population to support BA/BE NOC application To liaise CBN for regulatory approvals for conducting clinical studies in India. To coordinate with global regulatory authorities for regulatory strategic for various products and services Proactive co-ordination of all the necessary activities required regulatory submission. Preferred candidate profile: Education : Bachelor's degree in life sciences, pharmacy, or related field (Masters or advanced degree preferred). Experience : 5+ years of experience in regulatory affairs within a CRO or pharmaceutical/biotech industry, with at least 2 years in a managerial role. Knowledge : In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH), clinical trial regulations, and submission processes. Interested applicants can apply with their updated profile or Can send to email to hr@qpsbioserve.com

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions. Coordinate with CTD/eCTD vendors for preparation of dossiers. Review artwork, labeling, and specifications for regulatory compliance. Maintain master files and variation records according to ICH guidelines. Ensure timely submission of applications to relevant authorities. Desired Candidate Profile 3-6 years of experience in Regulatory Affairs (dossier preparation & submission). Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution. Strong understanding of Life Cycle Management (LCM), Product Lifecycle Management (PLCM), OSD regulations.

Role & responsibilities Hiring candidates with experience in CMC Regulatory Affairs in Pharmaceutical Industry across regulated and semi regulated regions with hands on experience into - Preparing submission content plans for CMC submissions including, post approval changes, renewals, product renewals, Module 3 baselines, and annual report/notifications. Execute regulatory team activities as directed to achieve submission approval for products in regulated and semi regulated regions. Review quality documents for post approval submissions as above. Author high quality Module 3 and Module 2 section /summaries. Maintains the general knowledge of CMC/M3 regulations and guidance for Injectables. Coordinate with stake holders (R&D, Plant and suppliers) for sourcing of documents and review of executed documents received. Perform data entry within the regulatory databases. Report and escalate incidents as situation demand. Carry out the activities as per assigned by the immediate supervisor from time to time, for which he/she is authorized as per the SOP trainings. In depth understanding of Health Authority expectations for pharmaceutical types for the regulated and semi regulated regions. Must possess organization skills, time management skills and attention to details. Must possess strong communication skills, critical thinking, interpersonal skills and interpretation skills. Should understand business presentation and communicate descriptions of problems and solutions. Preferred candidate profile M Pharm, M Sc or B Pharm with min. 2 to 6 years experience in CMC Regulatory Affairs in Pharmaceutical Industry across regulated and semi regulated regions. Work experience into sterile/ parenteral products would be an added preference.

Dear Candidates, Greetings of the day! Harman Finochem Limited is an India-based Pharmaceutical Company catering to its clients across the globe, established by Late Mr. Bhupinder Singh Manhas in 1983, our core competencies are in manufacturing and exporting of Active Pharmaceutical Ingredients mainly Metformin HCl, Fenofibrate, Divalproex Sodium, Riboflavin Phosphate Sodium, Glycopyrrolate/Glycopyrronium bromide and more. We have two USFDA approved manufacturing facilities at Shendra & Chikalthana, Aurangabad. We are hiring for "Regulatory Head - API Division" for Shendra, Aurangabad location, who will be responsible for three API units. Role & responsibilities : 1. Responsible to review and submission of DMFs/E-DMFs/CEPs to US-FDA, Europe, EDQM, Health Canada, PMDA, China, Korea, Brazil and Rest of World. 2. Ensuring timely readiness of dossiers for all submissions. 3. Co-ordination with other departments to resolve the issues and queries related to submitted dossiers. 4. Quality and speedy response to the Regulatory agencies queries and Customer queries. 5. Conduct training on DMF compilation, submission and guidelines to build regulatory team of well-rounded professionals 6. Evaluation of manufacturers of staring material & primary packing material for use in Active Pharmaceuticals Ingredient. 7. Monitoring and communicating new and changing regulations to concern Department. 8. Maintenance of DMF fees and facility fees (self-identification) in accordance to GDUFA Evaluation of change controls and other documents. 9. Maintaining self-identification of our facilities & establishment renewal to US FDA. 10. Review and submission to drug listing (Label) of our API to US-FDA. 11. Maintaining the D&B renewal for our facilities. 12. Maintaining the life cycle of submitted DMFs, annual-updates, amendments and variation filings as per the stipulated timeline. Preferred candidate profile : Education : BSc/MSc Experience : 16 to 25yrs of experience in API Pharma Industry into Regulated market Good in Team Management Perks and benefits : As per company standard

Position Title: Scientific Writer Team: Regulatory Science Operations Job Type: Contract Job Location: Hyderabad (Hybrid) Job Description This is an exciting opportunity for a highly motivated individual to join Regulatory Science as a Scientific Writer and to be part of the Regulatory Sciences Operations team. The Scientific Writing Team drafts study reports and study summaries to support regulatory submissions for both biotech and crop protection products. This role will have a high emphasis on analytical chemistry. Scientific Writers collaborate closely with stakeholders and customers including Study Directors and Monitors, Subject Matter Experts, Quality Assurance, Statisticians, and Global Registration Teams. Job Summary Draft high-quality study reports and study summaries to support regulatory submissions for both biotech and crop protection products (this role work with analytical chemistry reports primarily). Strong scientific writing skills and a background in science (specifically analytical chemistry) is needed for drafting reports. Perform quality control reviews on draft reports and/or raw data. An understanding of Good Laboratory Practice (GLP) is required. Develop new report templates, optimize processes, and assess stakeholder feedback for continuous improvement. Coordinate peer reviews and Quality Assurance audits, collate comments, and facilitate finalization of reports and audit responses. Communicate effectively with key stakeholders and customers. Partnership with stakeholders and customers to understand regulatory reporting requirements is important for success. Job Qualification MSc (with knowledge in chemistry, biochemistry, or analytical chemistry); industry experience is preferred. Other degrees may be considered if proficiency in critical skills is demonstrated. Hands-on experience in different HPLC (or analytical) techniques, Interpret the test results with high accuracy from the raw data. Knowledge on writing protocols/ reports based on study (HPLC or other analytical test) findings. 2 to 7 years of relevant experience The ideal candidate will have experience in analytical chemistry Highly proficient in English, both spoken and written. Excellent verbal communication skills, which includes the ability to work effectively in a team environment. Excellent written communication skills, which includes strong keyboard and data entry skills and strong knowledge of Microsoft Word, Excel, Outlook, and Adobe Acrobat. Excellent attention to detail and ability to work on several projects simultaneously, efficiently, and independently. Excellent interpersonal skills with the ability to interact with a diverse set of stakeholders. Ability to work a partially-modified schedule to ensure overlap with our US-based teams, facilitating real-time collaboration and communication during key business hours.

RESPONSIBILITIES Coordination with the customer to compile the dossier as per current registration regulations in SEA & East Africa markets. Coordination with the customer at various registration stages to obtain approval. Analyze the molecule and determination for need of Bioequivalence or bio waiver studies. Life cycle management of product license by filing renewals and analyzing the type of variation needed to be based on the proposed changes to DMF, formulation, packaging, or excipients. Review and approve the artworks as per Brazil and Canada market regulations. Interpretate deficiencies received compile and submission responses within the stipulated time frame. Maintenance of tracker for submission and deadline for responses and coordination with stakeholders to submit responses within stipulated deadlines. DESIRED SKILLS Good knowledge of Registration requirements in ROW market. Experience in submission of generic medicine dossiers to the ROW market. Good technical knowledge, review skills and understanding of regulatory submissions Strong knowledge of CTD/ ACTD requirements for submission of dossiers to SEA , ME & AFRICA markets. Good analytical and problem-solving skills. Ability to try new approaches when faced with challenges. Should have a good analytical and learning attitude. Proactive to submission of response to any queries. Good communication skills.

Job Details for Executive Regulatory Affairs Compilation of DMF in eCTD format and submit to regulated and semi regulated markets. Review and co-ordinate with other cross functional teams for responding the queries raised by regulatory authorities to the submitted DMF within timeline. Review of post approval changes and technical requirements as per regulatory perspective for submission of Amendment/Variation to respective countries. Handling the marketing requests and respond to customer queries Review of Specifications and analytical related documents for submission purpose. Review of technical documents like Batch records, Process validation reports, analytical method validation reports etc. Assessment of change proposals from regulatory perspective. Regulatory compliance for assigned projects of advanced markets (USA, EU, Japan, Brazil, China) Preparation & Submission of Annual reports of USDMF products for all minor changes of Commercial and Exhibit products. Maintaining the database of post approval DMF Amendment/variation submissions and their approval status with implementation details. Maintaining log for Product History as per regulatory perspective. Good understanding of cGMP

Position: Manager Grade : G10 Job Location : Gurgaon (preferable)/Baroda/Mumbai Education : M. Pharm Department : Global Regulatory Affairs Specialty Pharma Job Responsibilities Serve as a Regulatory CMC Product team member and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU & Canada Ensure lifecycle management through timely submission of annual reports, supplements etc to ensure product continuity The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures. Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal. Manage execution of CMC documentation including PIND/IND/CTA , original NDA/MAA , agency background packages and responses to health authority questions per established business processes and systems. Support new technology development within our Company. Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Branded products worldwide. Conduct all activities with an unwavering focus on compliance. May need to manage or mentor junior team members. Technical Skills: Hands of expertise of preparation & review of dossiers , response to queries, communication with agencies for developed markets like US/EU Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving. Leadership Skills: Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Demonstrated effective leadership, communication, interpersonal and negotiating skills. Education Minimum Requirement: M-Pharm in pharmaceutical sciences Required Experience and Skills: 5-12 years of hands-on experience in regulatory affairs This role needs a seasoned professional who is aware of the regulatory activities for NDAs , can work in R & D CFT and who has the management capability of leading a group of team members The candidate must be proficient in English; additional language skills are a plus. Good inter-personnel skills with ability to direct multi-departmental functions.