131 Dossier Preparation Jobs

We are seeking an experienced Regulatory Affairs professional to support and manage the regulatory lifecycle of oral solid dosage (OSD) products across key global markets, including the EU, USA, and RoW.

Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna. Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement. To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement. Responsible for prepare and review Drug Master File as per respective reulatory agency guidline. Responsible for ensuring that DMF submitting regulatory documentation, maintaning compliance and advising on regulatory strategies. To ensure that Drug Master File (DMF) meet to current respective regulatory agency guideline. Responsible for prepare Drug Master File (DMF) Deficiency response to respective regulatory agency. Responsible for prepare Drug Master File (DMF) Amendment report to respective regulatory agency. Responsible for prepare Drug Master File (DMF) Annual update report to respective regulatory agency. Assessment and notification of change to regulatory agency and customer as per regulatory requirement. Aim to serve as an internal API regulatory expert, ensuring regulatory compliance within the cross-functional teams. Responsible for scheduling the life cycle management activities globally for all the regulatory submissions complying with region specific requirements including continuous improvement programs.

Total Experience Required: Minimum 4 years in the Core Regulatory Affairs Department Qualification: B.Pharma/ M. Pharma Minimum 4 years of experience in the compilation and preparation of dossiers for semi-regulated and regulated markets. Analyze and respond to inquiries from regulatory agencies and customers worldwide, ensuring timely submissions within set deadlines. Maintain a well-organized and up-to-date regulatory filing system, including databases and chronologies, for easy tracking of changes made to documents submitted to agencies or partners. Proactively update existing internal regulatory guidelines and develop new ones as needed to ensure alignment with current requirements. Continuously stay informed about the latest regulations, guidance documents, and standards set forth by the FDA, international regulatory bodies, and domestic agencies relevant to the company's products. Conduct thorough reviews of CMC (Chemistry, Manufacturing, and Controls) documents within established timelines. To co-ordinate/ follow up for technical departments like R&D, QA, QC, ADL and Manufacturing, for arranging the documents required for preparation/ compilation of Dossiers within defined timelines. Managing the Registration Sample to deliver it to the customers within defined timelines. Timely submission of dossier/ post approval submissions to the various Regulatory Authorities and the subsequent life cycle management. To collect and compile the necessary documentation for the raw materials (Active Pharmaceutical Ingredients (API) and excipients) used in the manufactured batches intended for the registration of medicinal products in foreign countries. Additionally, to address and resolve any queries raised by government authorities during the registration/reregistration process. Take ownership of additional duties assigned to support the Regulatory Affairs department.

1. Drug Regulatory Affairs - Job description Prepare CTD, ACTD Dossiers and file regulatory submissions Perform assessments of new or revised products Manage complaint documentation (including investigation and closure) Respond to inquiries from regulatory bodies Should be technically well versed with requirements for Medicines with fare knowledge about Food supplement, medicines To Coordinate with relevant department for arranging documents To prepare / compile dossier for allocated products / countries To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc To coordinate with courier agency for dispatches of dossier /samples To make timely entries of submissions / dispatches Qualifications :- A bachelors degree in B. Pharma Experienced with 1 year Should apply. Excellent communication skills Should be aware about Microsoft office [word / Excel/ PPT] - Good inData management Contact No- 8810226562

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other domestic markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 4 years of exp in Formulation OSD 2. Willing to work in Chennai 3.Strong expertise in EU, EMA, MHRA & other international regulatory framework 4. Exposure in domestic regulatory market

Role & responsibilities Exploration of updated guidelines needed for dossier compilation for ROW market/ Regulated Market. Preparation, compilation, review, and submission of Pharmaceutical Dossiers to emerging market as per International Conference on Harmonization (ICH) and country specific guidelines in Common Technical Document (CTD), Asian Common Technical Document (ACTD) and regional format. Internal communication & follow-ups with various departments for various documents. To arrange and send samples for registration purpose to various countries. Review at all quality data received from various departments before using in dossiers and technical packages. Preparation and submission of Query response raised by the Health Authority. To undertake any other assignment given by superior of the department / management from time to time. To support in documentation in national and international tenders. Management of Product Database. Archival of dossier. For COPP Application- Support with documents. Preferred candidate profile Must be from Formulation background interested applicant can send CV on shital@mjbiopharm.com , janhavi.shedekar@mjbiopharm.com or contact on 9867700982. Perks and benefits

As a Jr. Officer to Sr. Officer at our company, you will be responsible for the following: - Preparation of dossiers and documents in compliance with CTD, ACTD, and country-specific guidelines. - Reviewing dossiers, DMF, and technical documents. - Addressing queries raised by regulatory authorities. Qualification Required: - Must have an M.Pharm degree. The work location for this position is in Jarod, Vadodara, Gujarat. Additionally, we offer benefits such as health insurance, leave encashment, life insurance, paid sick time, and provident fund. Please note that this position requires a long-term association agreement with an incentive scheme for 2-3 years.,

Role & responsibilities Regulatory Strategy Development : Develop and implement regulatory strategies for the registration and market access of pharmaceutical products, particularly injectables, in ROW regions including Africa, CIS, LATAM, etc. Monitor and assess regulatory trends, changes in legislation, and health authority requirements in these regions. Identify regulatory pathways for new product launches and lifecycle management of existing products. Regulatory Submissions and Approvals : Prepare and submit regulatory dossiers for new product registrations, variations, and renewals for injectables across multiple jurisdictions (e.g., Africa, CIS, LATAM). Coordinate and manage the submission of regulatory documents (CTDs, eCTDs, dossiers, clinical trial applications) to the relevant health authorities. Facilitate communication with health authorities, responding to queries, and ensuring compliance with regulatory timelines. Compliance Management : Ensure that all pharmaceutical products (particularly injectables) comply with regulatory requirements in target markets across ROW. Review product labeling, packaging, and advertising materials to ensure compliance with local regulatory guidelines. Manage post-market surveillance requirements, including reporting adverse events (AEs), product recalls, or any regulatory non-compliance in the region. Cross-functional Collaboration : Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure that the products meet regulatory requirements throughout the product development lifecycle. Provide regulatory input and support during the product development phase, particularly for injectables, which often require more complex regulatory scrutiny. Collaborate with marketing and sales teams to ensure that product claims and promotional activities align with local regulatory requirements. Regulatory Intelligence : Continuously track and evaluate changes in drug regulations, including GMP (Good Manufacturing Practice), GxP, and other relevant policies across various countries in ROW. Act as the internal subject matter expert on regulatory issues related to injectables in ROW markets. Monitor competitor activities and regulatory trends in the ROW regions, particularly for injectables. Regulatory Affairs Leadership : Lead and manage a team of regulatory professionals across the ROW regions, guiding their work in regulatory submissions and compliance activities. Provide mentoring and training to team members to enhance their regulatory knowledge and skills, particularly in the injectables segment. Risk Management & Problem Solving : Identify and mitigate regulatory risks related to the approval process for injectables in target regions. Address regulatory challenges or delays and take proactive steps to resolve issues, including negotiating with health authorities or addressing deficiencies in submissions. Regulatory Advocacy and Relationship Management : Build and maintain strong relationships with key regulatory authorities in various ROW regions, including ministries of health, regulatory bodies, and industry associations. Represent the company at regulatory meetings, conferences, and workshops related to pharmaceutical regulations and injectables. Documentation & Reporting : Maintain accurate and comprehensive regulatory files and documentation for products, especially injectables, in compliance with regional regulations. Provide regular updates to senior management on regulatory milestones, challenges, and market access status. Preferred candidate profile Must have experience into injectables dosage forms.

WALK IN DRIVE R&D MUMBAI Interested candidates need to register through the QR code or link given below (works best on Google Chrome) https://macleods.in/HR/Ad.aspx?VAL=RjFndFFJSVZWY2lSQ2ZxQXBzdzczUT09 Department : Regulatory Affair Experience : 6 - 11 Years Designation : Sr. Executive/ Executive (US, Europe, South Africa, Africa, AU, NZ & Canada) Qualification : M.Pharma Location : Mumbai Job Descripition 6 -11 years of experience in pharmaceutical regulatory affairs, including leadership roles and expertise in global regulatory requirements and guidelines including FDA, EMA, and ICH regulations. Thanks & Regards HR Team

- Handling vendor approval requests – filling forms, Questionnaires, sharing FAQ, documents etc. - Handling regulatory requests / queries from customers. - Maintenance of regulatory documentation in electronic format and saving key communication. Required Candidate profile - 2+ years of experience in Pharma Regulatory Affairs. - B.Pharm / M.Pharm - Good Communication skills, Time Management and IT skills

Regulatory Submission & Approvals , Compliance & Documentation, Liaison & Communication, Latam Countries, Complaint Handling Share updated Cv Jobs@asmohlab.com

Job Responsibilities: Dossier preparation/review as per country specific guideline/CTD guideline Timely query response submission to Distributor/ MOH Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement) Preparation, review & release of artworks & sales order as per country approval Variation documents preparation and filing as per country requirements Timely dispatch of tender documents to country/parties as per deadline Candidate profile Should be able to review & interpret the requirement as per country specific/ tender guideline/Query received from MOH Should be able to review various plant documents for dossier preparation like Process validation, Stability study, PDR, Method validation, SOP, Drug Master File, BMR, APR etc. Should be able to communicate with relevant functions for procurement of required regulatory documents Should be able to communicate with relevant business partner at country

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a Trusted Emerging Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Client Name: Australian Global Pharma specialist in Pharmaceutical & Medical Device Position: Assistant Manager - Regulatory Affairs Markets: UK & Europe Products: Solid Oral, Injectable, Topical Location: Bangalore Job Profile: Regulatory Strategy & Planning: Support the development and execution of regulatory strategies for product registration and lifecycle management in the UK market. Assist in regulatory risk assessment and provide input during product development, launch, and post-marketing phases. Stay updated with MHRA and EU regulatory requirements, and ensure integration into company processes. Dossier Preparation & Submission: Prepare, review, and submit high-quality regulatory dossiers including 1. Marketing Authorization Applications (MAA) 2. Post-approval variations (Type IA/IB/II) 3. Renewals 4. Line extensions 5. Clinical Trial Applications (if applicable) 6. Responses to regulatory queries and deficiency letters 7. Compile and maintain product documentation in eCTD, NeeS, or paper format (as required). 8. Coordinate with global teams to obtain required documentation for submission. Product Lifecycle Management: Maintain Marketing Authorisations (MAs) for assigned products in the UK. Ensure that labeling, artwork, and product information (SmPC, PIL, and labels) are compliant with current UK/EU legislation. Monitor timelines and ensure timely submission of periodic safety update reports (PSURs) and risk management plans (RMPs), as applicable. Regulatory Communication: Act as a liaison with the MHRA and other regulatory bodies to facilitate the approval and maintenance of products. Respond to questions and requests from health authorities efficiently and professionally. Cross-functional Collaboration: Work closely with cross-functional teams including R&D, QA, Manufacturing, Supply Chain, Pharmacovigilance, and Medical Affairs. Ensure consistent regulatory input during formulation, scale-up, process validation, and batch release. Regulatory Intelligence & Compliance: Monitor changes in the UK and EU regulatory environment (including post-Brexit developments). Interpret and communicate regulatory updates to internal stakeholders. Ensure regulatory processes are compliant with internal SOPs and global regulatory standards (EMA, ICH, MHRA). Desired Profile: B.Pharm / M.Pharm / M.Sc with 5 to 10 yrs experience in Regulatory Affairs with Pharmaceutical company preferably focused on the UK / EU markets. Experience & knowledge in the preparation of major regulatory submissions & supportive amendments or supplements. Must have exposure in UK or EU. Experience with MHRA submissions is a must. Knowledge of post-Brexit regulatory landscape, including the separation of EU and UK procedure. Proficient in preparing & compiling eCTD/NeeS format dossiers using publishing tools (e.g., Extedo, Lorenz). Strong knowledge of SmPC, PIL, and labeling requirements under UK and EU laws. Familiarity with Common Technical Document (CTD) structure & ICH guidelines. Experience with generic, branded, or biologic drug submissions. Exposure to CP (Centralised Procedure), MRP (Mutual Recognition Procedure), & DCP (Decentralised Procedure) is a plus. Working knowledge of Quality Management Systems (QMS) & pharmacovigilance frameworks. Certification or training in regulatory affairs (e.g., from RAPS or TOPRA). Excellent communication & interpersonal skills. Strong analytical & problem-solving abilities. Meticulous attention to detail. Ability to manage multiple priorities and work under pressure. Recruiter Details: BEST - FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India Mobile: 09722052906, 09722042906 E-Mail: career@bfrr.in Website: www.bestfitrecruitment.co.in

Intas is a leading global pharmaceutical company dedicated to the development, manufacturing, and marketing of pharmaceutical formulations. The company's mission is to meet unmet medical and societal needs through a fully integrated pharmaceutical value chain that spans across the globe. With a presence in over 85 countries, including major markets like North America, Europe, Latin America, and the Asia-Pacific under the brand name Accord Healthcare, Intas has experienced rapid expansion through organic growth and strategic acquisitions. The company upholds high standards of quality with products approved by leading global regulatory agencies such as USFDA, MHRA, and EMA. Intas also focuses on advanced areas like Biosimilars and New Chemical Entities to excel in healthcare. At Intas, success is attributed to the strength of its people. The company is committed to attracting and retaining top talent in the industry and creating an empowering environment that fosters innovation and excellence. This ensures that every employee contributes significantly to both the company's growth and advancements in global healthcare. **Job Title:** Asst Manager-Global Portfolio & Bus Dev. **Job Requisitions No.:** 13742 **Job Description:** **Purpose of Job:** The ideal candidate should possess basic knowledge of pharmaceutical development for Dossier preparation for the Global Market, particularly for oral/injection/topical dosage forms, and US/European pharmaceutical IP and Regulatory strategy. Experience in pharmaceutical business intelligence and business case analysis for new project selection and approval is desirable. This role involves interaction with internal and external departments within a multidisciplinary matrix team, necessitating cross-functional skills, leadership, and motivation. **Roles and Responsibilities:** - Identify, evaluate, and monitor Pipeline Projects - Participate in internal and external development monitoring, Budgeting, launch calendar, and Portfolio slide preparation - Optimize Portfolio and select New Projects - Contribute to project strategy and business case analysis - Maintain internal databases related to Portfolio and Pipeline - Coordinate training sessions for the BD team to update on Product details - Assist in the preparation of Intas Launch Landscape for strategic territories (US, EU, AUS, CAN, LATAM) **Skills Required:** - Strong understanding of the subject - Excellent communication skills **Qualification Required:** - M. Pharm or B.Pharm & MBA **Relevant Skills / Industry Experience:** - Experience in Project Management or Portfolio Management **Location:** Head Office, Ahmedabad, GJ, IN, 380054 **Travel:** 0% - 25% **Life at Intas Pharmaceuticals:** Intas thrives on the exceptional talent of its people, fostering individual potential and collective success in a dynamic environment. The company values diverse skills and perspectives united under a shared purpose to drive innovation and excellence in the pharmaceutical landscape. **Date:** 16 May 2025,

Responsibilities: * Oversee regulatory affairs processes * Manage dossier submissions & preparations * Ensure compliance with the Latam market requirements * Lead row market strategies * Client query resolution. * Artwork review.

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory strategies to ensure compliance with international and regional regulations . Prepare, review, and submit regulatory documents in line with global requirements (US, EU, and emerging markets). Liaise with regulatory authorities to address queries and obtain timely approvals. Monitor evolving regulatory guidelines and industry trends , assessing their impact on product development and commercialization. Partner with R&D, Quality, Clinical, and Legal teams to provide regulatory insights throughout the product lifecycle. Support documentation for clinical trials , including protocols, investigator brochures, and informed consent forms. Conduct risk assessments and provide recommendations for safety reporting and compliance obligations. Participate in audits and inspections , driving corrective and preventive actions as needed. Provide regulatory training and guidance to internal stakeholders to enhance compliance awareness. Qualifications & Requirements Education: Bachelor’s degree in Pharmacy or a related scientific field (Master’s preferred). Experience: 7 - 8 years in pharmaceutical regulatory affairs within a global organization. Strong knowledge of FDA regulations (21 CFR Part 11), ICH guidelines, EMA, and regional market requirements . Demonstrated success in regulatory submissions leading to product approvals. Proven project management skills , with the ability to manage multiple projects in a dynamic environment. Excellent written and verbal communication skills for engaging internal teams and external authorities. Strong analytical, problem-solving, and decision-making abilities. Proficiency in regulatory information management systems and related tools.

Maintaining Quality Systems Ensuring cGMP compliance Prepare Batch Manufacturing Records Process Validation and Cleaning Validation Dossier Preparation and New Drug Applications Document Quality Risk activities Required Candidate profile Experience in GMP, ICH Q series and pharmaceutical quality systems Strong in documentation, audit preparedness and regulatory compliance

Role & responsibilities 1. To ensure that all required information is included in the regulatory filing. 2. To collect the documents require for dossier preparation. 3.To evaluate the country wise requirements for dossier preparation as per checklist. And compile a draft dossier as per requirements and in the format provided by the authority of the country. 4.To co-ordinate with Artwork, Purchase, QC, QA, R&D, Packaging, Licensing Department for necessary documents/data. Prepare documents for courier purpose and send the courier. 5. Keep a track of the courier to check delivery on time. Providing comments on the product, preparing and submitting a regulatory application, and working with other team members to help with the process. Preferred candidate profile : Reputed Pharma background only

Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all LATAM, MENA, CIS and ROW Countries and other country as per company requirements. Responsible for final review of dossier before submission. To coordinate with technical team for documents required for dossier. Responsible to gather data related for dossier through online sources, laboratories, manufactures, etc. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. Preferred candidate profile Qualification: B. Pharm and M. Pharm Experience: Minimum 5 years in ROW market for Formulation Dossier preparation and submission Perks and benefits Salary: 40,000 to 70,000 per month Mediclaim Bonus

Responsibilities As a regulatory affairs officer: ensure that a company's products comply with the regulations of the regions where they want to distribute them keep up to date with national and international legislation, guidelines and customer practices respond to queries from medical bodies like the Medicines and Pertaining to that Guidelines. collect, collate and evaluate scientific data from a range of sources develop and write clear arguments and explanations for new product licences and licence renewals prepare submissions of licence variations and renewals to strict deadlines monitor and set timelines for licence variations and renewal approvals work with specialist computer software and resources write clear, accessible product labels and patient information leaflets plan and develop product trials and interpret trial data advise scientists and manufacturers on regulatory requirements provide strategic advice to senior management throughout the development of a new product project manage teams of colleagues involved with the development of new products oversee product trials and interpret trail data undertake and manage regulatory inspections review company practices and provide advice on changes to systems liaise with, and make presentations to, regulatory authorities negotiate with regulatory authorities for marketing authorisation take part in the development of marketing concepts and approve packaging and advertising before a product's release. Role & responsibilities Preferred candidate profile

Job Title:Sr. International Regulatory Affairs Executive/Officer Companies: Pharma Location: Ahmedabad Bodakdev Exp: 4-6 Yrs email: jobs@winstonhrservices.com Whatsapp: 7383005000 Openings: 02 Required Candidate profile Preparing & review Dossiers for registration of products in various ROW markets Legalization of FDCA documents for respective country registration Preparing, managing FSC & COPP applications for FDCA

Role & responsibilities Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. Regulatory Compliance and Updates: Stay informed of changes in Asian or Regulated market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. Documentation and Record Keeping: Maintain well-organized records of submissions, communications, and approvals. Use regulatory software and systems for document tracking, version control, and report generation. Markets - Regulated (EU/UK/Aus) or ROW (Asia & Africa) Desirable Skills & Competencies: Attention to Detail: Ability to review and analyze technical documentation with precision. Collaboration: Effective communication skills for working with R&D, manufacturing, and quality assurance teams. Problem Solving: Proactive in identifying compliance issues and developing solutions to address regulatory challenges. Proficient in MS Office and regulatory documentation software. Interested candidates can apply or mail your resume on vaibhavi.b@titanpharma.com or -contact 022 - 6785 7000 (Ext 725). If you have good references you can share on above details. Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd

Role & responsibilities Responsible for overseeing all aspects of regulatory compliance within a company, ensuring that new drug product drug substance applications and marketed products adhere to all relevant regulations set by regulatory agencies like the MHRA, EMA, TGA ,DIGIMED and other international bodies, by leading a team to manage registration processes, maintain compliance, and strategically navigate complex regulatory landscapes to successfully launch and maintain pharmaceutical products on the market. Developing and implementing comprehensive regulatory strategies for new drug development, including clinical trial design, data submission plans, and market access strategies. Leading the preparation and submission of regulatory dossiers to health authorities for new drug applications, variations, renewals, and post-market surveillance reports. Ensuring adherence to all applicable regulatory requirements, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and labelling regulations. Building and maintaining strong relationships with regulatory agencies, proactively addressing any concerns or queries regarding product submissions. Managing and developing a team of regulatory professionals, including regulatory affairs managers, specialists, and associates, ensuring their expertise is utilized effectively. Monitoring changes in regulatory landscape, interpreting new guidelines, and communicating potential impacts to internal stakeholders. Identifying and mitigating potential regulatory risks associated with drug development and commercialization. Facilitating communication between regulatory affairs, research and development, clinical operations, marketing, and other cross-functional teams to ensure alignment on regulatory strategies . Preferred candidate profile Deep understanding of global pharmaceutical regulations, including ICH guidelines and relevant regional regulations. Extensive experience in the drug development process, from pre-clinical to post-market surveillance. Proven leadership skills in managing and motivating a regulatory affairs team. Excellent communication, negotiation, and interpersonal skills to effectively interact with regulatory agencies and internal Stakeholders. Strong analytical and problem-solving abilities to assess complex regulatory issues and develop solutions.

Job Description: Regulatory Affairs Executive (ROW Markets) Industry: Pharmaceuticals Experience: 3-5 Years Loaction: Chennai Key Responsibilities: Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets. Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers. Document Review: Review BMR, specifications, COA, MOA, and technical documents for compliance. Artwork Coordination: Ensure accuracy in labeling & packaging artwork with regulatory standards. FDA Compliance: Maintain records for FDA licenses (Product Permission, CoPP, FSC) . Legal Documentation: Track notarized & legalized documents for international submissions. Eligibility & Requirements: Education: B.Pharm / M.Pharm (Pharmacy graduates preferred). Experience: 3-5 years in regulatory affairs, dossier submissions, or pharma compliance . Skills: Strong knowledge of ACTD/CTD dossier formats . Familiarity with FDA, EMA, and ROW market regulations . Attention to detail in documentation & compliance checks . Proficient in regulatory tracking systems & MS Office .

JOB PROFILE OF SR. TECHNICAL OFFICER-QUALITY ASSURANCE MENDINE PHARMACEUTICALS PVT LTD Job Title / Designation- SENIOR TECHNICAL OFFICER - QA Qualifications- M.PHARM Experience- 5 to 10 years experience in QUALITY ASSURANCE Job Objective- The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing process. Job Responsibilities 1) Quality Risk Management 2) Batch Manufacturing Record preparation 3) Process Validation 4) Packaging Material Specification Preparation 5) APQR 6) Cleaning Validation 7) Regulatory Affairs activity 8) Dossier preparation 9) Application of ONDLS system 10) Form 29 & Form 30 preparation 11) Endorse documents preparation 12) New drug application 13) COPP application in ONDLS.