108 Regulatory Submissions Jobs - Page 2

The Manager - Nasal Spray Formulation Development will lead the development of innovative nasal spray formulations, driving projects from concept to commercial scale-up. You will focus on the design, development, and optimization of nasal spray drug products, ensuring regulatory compliance and meeting quality standards. Leading a team of formulation scientists, you will collaborate with cross-functional teams to deliver high-quality, cost-effective nasal spray formulations for global markets. Key responsibilities include having relevant experience in developing and technology transferring Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. You will be responsible for preparing and reviewing literature search reports for drug substances and products, proposing formulation strategies, guiding executives for development batches in the lab, providing expert input into formulation and process studies, and ensuring compliance with specifications. Additionally, you will evaluate vendors for packaging material, monitor stability studies, prepare Technology Transfer documents, coordinate with stakeholders, and adhere to GLP and GMP. Qualifications and Skills required for this role include an M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or related field with specialization in drug delivery systems or formulation science preferred. You should have 8-10 years of hands-on experience in formulation development, with at least 5 years focused on nasal spray or inhalation formulations. Technical expertise in nasal spray formulation techniques, drug-excipient interactions, device development, particle size distribution, viscosity, and droplet characteristics is essential. You should possess strong project management skills, experience in working with cross-functional teams, and knowledge of regulatory requirements for nasal spray formulations. Leadership qualities, excellent communication and presentation skills, problem-solving abilities, and a knack for innovation are crucial for this role. The work environment will primarily be based at the R&D center, with occasional travel to manufacturing sites, vendors, and regulatory meetings.,

Job description OBJECTIVE: To maintain optimum quality in Formulation research and generation of quality data in Formulation Development department to support the development of a safe and quality product. RESPONSIBILITY : Formulation development of oral solid, Liquid, Parenteral and semisolid products by QbD Approach for Regulatory & ROW markets. Technical assessments of projects (Screening of Project, pipeline) Scientific literature Search and patents evaluation for strategic development. Technical screening of API, RM, PM sourcing for F&D activity. Formulation Development Strategy preparation with design around opportunities & developing Bio-equivalent products. Provides support and guidance in scale up/Technology transfer activities for new Formulation development Projects Assisting and ensuring timely completion of development activities at in-house R&D lab, (Pre-formulation studies, formulation development, stability studies etc.,) Guiding the F&D teammates to timely complete the development activities. Review and summarizing technical data for milestone assessments. Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality. Responsible for review of analytical data (e.g. dissolution, assay, related substances, Blend uniformity, content uniformity etc.) Supporting regulatory team in health regulatory submission and query response. Maintain Evolet Healthcare Policy on Quality, Safety and Efficacy Value.

Role & responsibilities : Extend support on the compiling, submission and approval of Country Specific Submissions files for the responsible countries (NDA, LCM & post approval changes) Participate and extend support during initial submission planning Review & update the list of documents required for the submission (e.g., NDA, variation, tenders) Manage compilation and preparation of regulatory documents, information, data technical files to support approvals for new product registration, renewals and changes Preferred candidate profile :

Review, compile and Preparation of original drug master file (DMF)/ ASMF as per GUDFA guidance/EMA guidance in eCTD format for various agencies. Review, compile and Preparation of Response to Deficiency as received from Agency. Working on Life Cycle management of DMF including amendment, biannual update, Annual Reports etc. for various markets. Preparation of Applicants Part and sharing with Customers and resolving customers query. Sound knowledge about ICH guidelines GDUFA and EMA guidelines

Job Description OBJECTIVE: To maintain optimum quality in Formulation research and generation of quality data in Formulation Development department to support the development of a safe and quality product. RESPONSIBILITY : Formulation development of oral solid, Liquid, Parenteral and semisolid products by QbD Approach for Regulatory & ROW markets. To handle a team of 10 to 15 team members. Technical assessments of projects (Screening of Project, pipeline) Scientific literature Search and patents evaluation for strategic development. Technical screening of API, RM, PM sourcing for F&D activity. Formulation Development Strategy preparation with design around opportunities & developing Bio-equivalent products. Provides support and guidance in scale up/Technology transfer activities for new Formulation development Projects Assisting and ensuring timely completion of development activities at in-house R&D lab, (Pre-formulation studies, formulation development, stability studies etc.,) Guiding the F&D teammates to timely complete the development activities. Review and summarizing technical data for milestone assessments. Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality. Responsible for review of analytical data (e.g. dissolution, assay, related substances, Blend uniformity, content uniformity etc.) Supporting regulatory team in health regulatory submission and query response. Maintain Evolet Healthcare Policy on Quality, Safety and Efficacy Value.

Role & responsibilities Regulatory Affairs Associate Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established CLIENTprocedures and regulatory requirements Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches Be the interface with health authority (HA) and their systems for designated regulatory tasks e.g., management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA portals Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, certificates of pharmaceutical products, legal documentation, e.g., letters of authorisation, power of attorney, translations of regulatory documentation Provide support across the group for assigned non-drug project roles & responsibilities e.g., function as a designated point of contact or superuser Provide guidance and knowledge sharing within the RAM skill group If required, support in activities such as scheduling of regulatory submissions, PBRERs, etc. Minimum Requirements Education and Experience Relevant qualification and/or experience in science Minimum 5 years of experience from biopharmaceutical industry, or other relevant experience Proficient verbal and written English Project management skills Experience in document management and tracking databases Preferred Experience Some regulatory/medical/technical experience Knowledge of CLIENTbusiness and processes Some knowledge of CLIENT”submissions, compilation, publishing and approval processes, standards, systems and tools Experience of collaborating with people from locations outside of India, especially Europe and/or USA Skills and Capabilities Good written and verbal communication skills in English Cultural awareness Proficiency with common document management tools Ability to work independently and as part of a team Focus on continuous improvement and knowledge sharing Internal and External Contacts/Customers Lead RPM and members of the Global Regulatory Execution Team (GRET) and Global Regulatory Strategy Team (GRST) Other R&D skill groups, e.g., GRO, Operations Regulatory, Patient Safety, Reg TA (GRL & Regional Leads) Marketing companies Health authorities External collaboration partners “client” Legal “CLIENT”vendors for translation, document authentication, etc. Interested candidate Kindly drop your updated resume to below mail id Nithya_kumar@persolkelly.com Regards, Nithya CONFIDENTIAL NOTE: By submitting your resume or personal data, you acknowledge reading and agreeing to our Privacy Policy. You hereby provide voluntary consent to the collection, use, processing, and disclosure of your data by us and our affiliates, in line with the Privacy Policy. and applicable laws. If you wish to withdraw your consent or have any concerns, you may submit a request to our designated consent manager, as outlined in our Privacy Policy. We prioritize your privacy. SECURITY NOTE: We at PERSOLKELLY India or our representatives, do not ask job seekers for fees, personal banking information, or payments through unofficial channels. Official communications will only come from @persolkelly.com. Report any suspicious activity to Contactus_in@persolkelly.com. Click here to find out how you can safeguard yourself from job scams

RESPONSIBILITIES Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU, UK and AUS-NZ. Publishing in eCTD format and submission to respective Regulatory Agencies. Compilation and submission of variation applications for EU, UK and AUS-NZ. Review of documents related to compilation of dossiers and query responses. Up to date knowledge of regulatory guidelines and requirements. DESIRED SKILLS Must have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycle Should have handled initial MAA submission & Variations for EU. Good technical knowledge, review skills and understanding of regulatory submissions Strong knowledge of CTD /eCTD requirements for modules 2 and 3 is mandatory. Hands on experience with compilation of module 1 and portal submissions would be preferable. Ability to try new approaches when faced with challenges. Should have good analytical and learning attitude. Good communication (written and oral) and inter-personal skills.

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.

Role Description It is crucial for the bank to understand how profitable each businesses activity is and Finance has a responsibility to understand precisely the resource commitment the bank makes to any given client or transaction e.g. cost, capital, funding, liquidity and risk. Finance is playing a central role in keeping the bank focused on simplification and financial resource management. Liquidity Data Measurement and Reporting (LDMR) Analysis and Design is an integral part of the banks liquidity reporting framework responsible for regulatory interpretation of liquidity legislation and requirements, analysis and control. Liquidity Data Measurement Analyst is essential for ensuring the daily liquidity reporting activity is performed and completed timely thereby ensuring the timelines prescribed by multiple regulators are met and ensuring adherence to quality of report submitted. The person ensures accurate and timely reporting of liquidity positions, risk management, and operational efficiency to meet both internal and external reporting obligations. Liquidity data measurement involves integrating data from multiple sources. The person is responsible for managing, reconciling, and ensuring the accuracy of the data, reducing the risk of errors and inconsistencies. Your key responsibilities General responsibilities may include, but are not limited to: Primary objective of the role in LDM Feeds Team is to ensure timely and accurate reporting of Data. The Employee will be performing daily regulatory reporting activities and will be responsible for daily data validation, performing data quality and feed approval for multiple feeds. Understanding and analyzing the gaps observed in the reporting and also co-ordinate with the business owners / book owners to understand the major drivers for the movements. The employee will also be responsible for ensuring any queries/ requests from stakeholders are promptly attended to. The employee will also be involved in UAT testing for new/ changes in source feeds which impact daily global regulatory reports. The employee will be involved in automation, data extraction & analysis there by reducing the manual processing time in BAU. The employee would be required to support the data reconciliation team in terms of understanding the activity and providing support to the team. The employee will need to have good stakeholder management skills as the LDM team works and deals with global projects/ stakeholders. The data submitted by LDM feeds into various daily regulatory submissions. The role is a regulatory reporting role wherein the employee will be responsible for daily and monthly data submissions. The employee will also be responsible for producing reporting and analytics to help support the management and modelling of intraday liquidity risk. Position Specific Responsibilities and Accountabilities: Production and distribution of real-time liquidity data which is consumed by the reporting team into various regulatory reports. Ensure positive and productive engagement with stakeholders. Ensure daily and monthly data management reporting are done timely and are processed with utmost accuracy. Work with LDMR teams globally to gain a thorough understanding of business requirements and risk metrics (LCR, NSFR, ALMMM, Stress test) Working with Technology to translate business requirements into functional outcomes identifying control gaps & set up mitigating controls Run ad-hoc analysis and communicate results to key stakeholders. Performance of quality checks and reviews to ensure accurate and complete report production. Ensure standardization and streamlining of processes and implementation of governance framework around the same. Implementation of a robust control framework for the processes and ensure adherence. Engagement on change projects. Supporting Treasury Liquidity on Franchise initiatives/projects. Test Cases monitoring creation and quality of test cases, supporting UAT Testing. Your skills and experience Degree in Finance or similar qualification (MBA,B.Com) Strong data analysis skills & attention to detail. Strong communication skills, both oral and written. Be comfortable interacting with both managers, stakeholders and peers. Strong presentational skills ability to present large amounts of information succinctly. Inherent skills to detect issues with Audit mindset. Pro-active, motivated self-starter able to perform under pressure and tight deadlines. Hands on experience in dealing Microsoft Office (Preferred) Experience in working on data reconciliations and UAT testing would be advantageous. (Preferred) Working background of Tableau and SQL would be advantageous. (Preferred) Previous experience in production and review of BAU reports, validation and control, analysis and provision of business commentary. (Preferred) Understanding of regulatory reporting within a Banking environment or Treasury function. Liquidity reporting experience preferable but not mandatory.

Proficient in preparing & submitting regulatory fillings for product approvals, conducting clinical evaluations, managing risk assessments, ensuring post market compliance. Experienced in EU MDR 2017/745, US FDA, Indian MDR 2017 & ISO 13485 Standards Required Candidate profile Candidate from Medical Device company will be preferred. Deeply knowledge of EU MDR 2017/745, CE Marking, US FDA, Indian MDR 2017, ISO 14971 and Risk Management is mandatory for this position.

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities Draft, review and submit or support submission of Regulatory filings for Drugs and Medical devices (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer) for India/Sri Lanka/Bangladesh and Nepal Draft, review and submit or support submission of other Regulatory submissions for Drugs and Medical devices (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India/Sri Lanka/Bangladesh and Nepal market in accordance with applicable regulations and relevant guidelines Participates in the development and implementation of the regulatory strategy for drugs and medical devices Conducts regulatory monitoring of approved products by ensuring maintained files are current, ensuring regulatory compliance, evaluates the effects of an amendment or change and takes appropriate regulatory actions Able to develop and implement appropriate regulatory strategies for the responsible countries to ensure business optimization Monitor, track and provide project updates Support, supervise and review team projects before submission to relevant authorities To liaise with global regulatory team in obtaining materials for regulatory submission purposes, product related query from business and to address questions and issues which arise as part of registration Participate and maintain working relationships and providing regulatory intelligence to relevant functional and business unit's team members Support and assist supervisor in preparation of technical presentations/ meetings with the regulator and on various assigned tasks Assist in preparation, review and maintenance of labels, SOPs, and other departmental documents Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice

Company Overview Sri Sai Overseas Recruitments is a manpower recruitment and consultancy service provider established in 2019. It is led by professionals with extensive experience in the Gulf countries, particularly in the oil and gas sector. The company specializes in providing manpower and consultancy services to various regions, including India, the Middle East, and European countries, with a deep understanding of international clients needs. Headquartered in Vadodara, the company has between 11-50 employees. Job Overview Sri Sai Overseas Recruitment is seeking a Fresher for the position of Medical Writer. This full-time role is based in Vadodara and ideal for candidates with 0 to 1 year of work experience. The successful candidate will work in the field of medical writing, focusing on creating scientific documents and complying with regulatory standards. The position involves collaborating with various stakeholders, and is a great opportunity for a driven individual looking to start their career in medical writing. Qualifications and Skills An understanding of medical writing principles and practices. Knowledge in conducting literature reviews and synthesizing information. Competency in manuscript preparation, ensuring clarity and scientific accuracy. Proficiency in proofreading documents to maintain high quality and error-free writing. Experience or training in scientific research methodologies and techniques. Ability to assist in regulatory submissions and understand guidelines and requirements. Excellent communication skills to articulate complex scientific information effectively. Attention to detail, with strong organizational skills to manage multiple projects. Roles and Responsibilities Create and develop medical content for various documents, including clinical study reports and research summaries. Conduct comprehensive literature reviews and integrate findings into clear, concise reports. Assist in the preparation of manuscripts for peer-reviewed journals and scientific meetings. Review and proofread medical documents to ensure precision and adherence to standards. Collaborate with researchers, clinicians, and other writers to deliver quality content. Support the preparation and submission of regulatory documents to maintain compliance. Organize and manage document files and maintain versions for different stakeholders. Stay updated with current trends and best practices in the field of medical writing.

Key Responsibilities: Perform analytical testing and analysis of raw materials, intermediates, and finished pharmaceutical products. Conduct instrumental and wet chemistry techniques, including HPLC, GC, UV-Vis, FTIR, and titrations. Develop and validate analytical methods for new and existing pharmaceutical formulations. Conduct stability studies and ensure proper documentation of results. Maintain and calibrate laboratory instruments and equipment. Prepare and review standard operating procedures (SOPs) for analytical testing and instrument operation. Ensure compliance with cGMP (current Good Manufacturing Practices), ICH guidelines, and other relevant regulatory standards. Support analytical troubleshooting and provide solutions for any issues that arise during testing. Review and interpret data, providing detailed reports and documentation for regulatory submissions. Collaborate with cross-functional teams, including R&D, production, and regulatory affairs. Conduct investigations and root cause analysis in case of product quality deviations. Maintain accurate records of all laboratory activities and ensure data integrity. Stay updated with new analytical techniques, instruments, and industry trends.

As a project PK Scientist develop or oversee the development of protocols, statistical analysis plans, PK/PD analysis, PK/PD tables, listings and figures, and clinical study reports for Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, mass balance, concept testing, bioavailability, thorough QTc, drug-drug interactions, and special population (age effects, renal disease, hepatic disease, gender effects, etc.), as well as population PK/PD studies. Consult with clients, external IQVIA divisions, and Clinical Pharmacology staff on study design, or other aspects of Clinical Pharmacology projects, and clinical development plans. Prepare PK/PD sections of global dossiers for product registration and communicate with local regulatory agencies. Ensure quality and timely delivery of the project PK/PD deliverables to IQVIA clients. Provide update to the IQVIA Project Manager on status of project PK/PD deliverables. Participate on project-related cross functional teams that include Project Manager, CRA, Data Manager, Biostatistician, Programmer, and/or Medical Writer. Consult and interact with clients, other IQVIA divisions, and third-party vendors. Provide technical training, guidance, and mentorship to lower level and new staff. Participate in proposal and budget development for Clinical Pharmacology PK/PD components of business proposals. Recommend and assist in implementation of quality control (QC) assessment and procedures and scientific review. Assist management in implementing strategic initiatives. Maintain awareness of overall developments in the field of Clinical Pharmacology and PK/PD based on current literature, application of new technology, attendance at professional meetings, etc. Perform other duties as assigned by Clinical Pharmacology Management. Qualifications Ph.D. or educational equivalent in Pharmacokinetics, Pharmaceutics, or related field Req Or Masters Degree or PharmD in Pharmacy or related field Req 5 years experience Req Or 7 years experience Req Or Equivalent combination of education, training and experience Req Sound knowledge of Pharmacokinetic concepts, including noncompartmental analysis and population PK modeling as required, current therapeutic environment and drug development trends Sound knowledge of appropriate PK/PD standards and processes Strong understanding of the principles of the drug development process, ICH GCP, and applicable International and national regulatory requirements Good coaching and mentoring skills Good problem solving and analytical skills Excellent computer skills, including proficiency with Microsoft Office, WinNonlin, and SigmaPlot graphics, as well as NONMEM, SPlus and basic SAS programming, as required Excellent verbal and written communication skills and highly effective interpersonal, and organizational skills Ability to work within a matrix team environment Ability to prioritize, and independently coordinate and manage PK/PD component of complex projects Ability to interact in a cross-functional and multi-cultural team environment Ability to establish and maintain effective working relationships with coworkers, managers and clients

Lead clinical trial statistics: develop protocols, design studies, create TLGs, review ADaM specs. Manage statistical deliverables, mentor team, collaborate cross-functionally. Support CTR prep, regulatory submissions, QC validation. Required Candidate profile Postgrad/PhD Statistics. 3+ yrs clinical trial biostatistics experience. Expertise in protocol design & statistical programming (SAS/R). Regulatory submission knowledge. Team leadership abilities.

Team Supervisor – IT Audits GradeM5/M6/M7 LocationMumbai Job Role Lead and manage a team of IT Auditors to deliver multiple IT Audit assignments including IT Application and Infrastructure Audits, Application Security Assessments, Vendor Audits, Concurrent Audits, Thematic Assignments, Regulatory submissions etc. Develop the Risk Based Audit Framework, meeting RBI regulations and adopting ISO 27001 Standards and preparing the IT Audit plan for the bank after scoping, budgeting and meeting with key stakeholders such as the CTO, CISO and CRO. Manage and liaison with outsourced audit partners with an emphasis on audit time and cost reduction, improvement in efficiency without the need of additional resources and delivery of high quality audit work products which can be presented to the board. Perform Human Resource Management activities, including evaluating performance, recruiting and retaining top talent and developing training plans for the team. Establish and maintain the Quality Assurance and Improvement program and facilitate internal and external quality assessments. Engage in advisory roles as a way to provide support to IT projects pertaining to internal controls and IT risk management. Team mentoring and internal recruitment Job A degree holder with 5-10 years’ experience in IT IT Audits, preferably in the BFSI segment. Should hold a CISA certification. Other preferable certs include CISM/CRISC/CISSP. Effective verbal and written communication Sound knowledge of key RBI circulars Effective project and relationship management skills, preferable with team handling experience. Critical thinking, analytical skills, efficient data handling skills High energy, Passion & Self starter attitude with good presentation skills, strong time management and organizational skills, including ability to multi-task. Strong interpersonal skills and ability to work as a team. Willing to travel as needed.

Description. Regulatory Consultant (Sterile Experience). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Experience in regulatory submissions for sterile drug products, including aseptic and terminal sterilization processes.. Preparation and review of Module 3.2.P sections related to sterile manufacturing, microbial control, and container closure systems.. Post approval variation experience is mandatory for EU market.. Familiarity with EU Annex 1 requirements and its application in variation, renewal submissions.. Supports in preparation and peer review of regulatory submissions including variations, renewals, and responses to queries.. Handling post-approval changes related to sterile facilities, cleanroom classification, sterilization methods, and equipment upgrades.. Preparation of regulatory assessments and submission strategies specific to sterile dosage forms.. Reviews of media fill protocols, filter validation data, sterility assurance, and cleaning validation documentation for submission readiness.. Provides regulatory support during inspections and audits related to sterile manufacturing.. Change control assessments and preparation of regulatory impact summaries.. Day-to-day execution of tasks in accordance with client SOPs and regulatory standards for high-quality global CMC dossiers.. Collaboration with cross-functional teams including QA, QC (microbiology), validation, technical, analytical, and site functions for data collection and dossier preparation.. Secondary. Acts as a point of contact for coordination of documentation across functional teams to meet submission timelines.. Effective communication through email and calls with internal and client stakeholders for updates and clarifications.. Supports and mentors junior team members depending on project needs.. Hands-on experience with RIMS/Veeva Vault.. Open to working in cross-cultural and virtual team settings.. Qualifications. Minimum 6 years of experience required for regulatory submissions for sterile drug products with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.. Excellent interpersonal / communication skills including excellent written and verbal communication skills.. Excellent customer service skills, with the ability to work both as a team member and independently.. Good quality management skills.. Advanced skills in Microsoft Office Applications.. Ability to interact with staff from multiple departments and offices to establish project standards.. Good initiative, adaptability, and pro-activity.. Strong analytical skills, good attention to detail.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Description. Sr Regulatory Consultant (Portfolio Management, EU mkt). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Minimum 5 years of experience in the European regulatory market.. Must have experience of end-to-end portfolio management within the EU region; global exposure is highly desirable.. Strong expertise in regulatory planning and strategy, including dossier preparation for filings, project management, labeling, and development of regulatory processes and procedures.. Hands-on experience with CTD modules 1 through 4, with a deep understanding of regulatory requirements and documentation standards.. Responsible for day-to-day contribution to project teams and projects.. Acts as a representative of the GRAS regulatory department with other departments.. Contributes technical expertise to proposals and assists with Business Development initiatives.. Understands project budgets, scope of projects, allocated hours, and tracks compliance.. Interacts with internal and external personnel, clients, and technical experts on projects.. Conducts regulatory research on projects as needed.. Provides operational advice to clients.. Prepares consulting reports under guidance.. Arranges, leads, and reports on client meetings.. Contributes to regulatory agency meetings.. Writes IND and product registration dossiers, clinical reports, and other regulatory documents for submissions.. Prepares full regulatory submissions for INDs, product registrations, and post approval maintenance activities, and participates on project teams.. Acts as a resource for technical knowledge.. Participates in quality improvement efforts to increase overall operational efficiency.. Contributes to the building of the regulatory systems and infrastructure needed for GRAS.. Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry eventssuch as seminars and association meetings, authoring articles for trade journals, and participating in industry association through memberships and on committees.. Provides internal training in appropriate areas of expertise to other Departments.. May act as a Line Manager to a small team, dependent on the location.. Qualifications. BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. PhD preferred.. Moderate regulatory, pharmaceutical/medical device related experience.. Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, MAA, and CTD, including electronic submissions. Experience in niche submissions such as ODD, PIP/PMP an advantage.. Excellent interpersonal / communication skills including excellent written and verbal communication skills.. Excellent customer service skills, with the ability to work both as a team member and independently.. Good quality management skills.. Problem-solving and decision-making skills.. Advanced skills in Microsoft Office Applications.. Ability to interact with staff from multiple departments and offices to establish project standards.. Good initiative, adaptability, and pro-activity.. Strong analytical skills, good attention to detail.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Markets, LATAM, ROW International @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

Roles and Responsibilities Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities. Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc. Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format. Preparation of query response for submitted applications received from various regulatory authorities. Responsible for review of change controls and checking for regulatory compliance for all documents. Exposure of Dossier compilation for ACTD & CTD is mandatory. Coordination with the external stakeholders for the preparation of the regulatory documents. To be responsible for the Life cycle management of assigned products. Should have experience for Life cycle management and license Maintenance. Should have good knowledge for recent guidelines, websites and trends of Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Desired Candidate Profile Candidate must have good knowledge of working in Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market. Perks and Benefits Best in industry. Immediate Joiners preferred

* Collaborate with cross-functional teams on regulatory strategy . Stay current with evolving regulations related to Sulphur import/export in different countries, including customs regulations, trade agreements, and safety standards Annual bonus Provident fund Accidental insurance

Roles & Responsibilities: 1. Product Registration: Handle the registration of products under FDCA (Food and Drugs Control Administration) for necessary approvals. 2. Label Claim Verification: Coordinate with the Formulation & Development team to confirm and validate claims mentioned on product labels and the regulatory classification of each product. 3. Artwork Coordination: Work closely with the sales team to ensure that product artworks (for existing and new products) meet all relevant regulatory requirements. 4. Renewals & Compliance: Manage the timely renewal of product approvals under applicable regulatory bodies, maintaining full compliance throughout the product lifecycle. Qualifications: 1. Bachelors or master’s degree in pharmacy , chemistry, or a related field. 2. 1–2 years of experience in regulatory affairs (preferably in cosmetics, personal care, or pharma). 3. Good knowledge of FDCA and other relevant cosmetic product regulations. 4. Strong communication, coordination, and documentation skills. 5. Detail-oriented with a proactive approach to compliance and deadlines.

Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) QC submission dossiers or parts of submission dossier output of low-to-moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre-established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties

Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) QC submission dossiers or parts of submission dossier output of low-to-moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre-established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties

Responsibilities: * Ensure regulatory compliance at all times * Prepare regulatory submissions accurately * Collaborate with cross-functional teams on product launches * Manage regulatory affairs portfolio