42 Row Market Jobs - Page 2

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.

Role & responsibilities - Preparing Dossiers for registration of products in various ROW markets - Knowledge of CTD format is mandatory Preferred profile Qualification: B. Pharm and M. Pharm Experience: 2 years Salary: 20,000 to 40,000 per month Health insurance Accidental insurance Annual bonus

We are looking for Right of Way (ROW) and Lead land acquisition processes for high voltage transmission projects. Handle negotiations, legal documentation, govt. clearances, and stakeholder management to ensure smooth and timely project execution.

Role & responsibilities Regulatory Strategies & Submissions: Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs. Preparing and submitting regulatory documents like Drug Master Files (DMFs) and marketing authorization applications (MAAs) to regulatory bodies. Preparation and Compilation of dossiers in CTD & eCTD. Collaborating with cross-functional teams to address regulatory queries in a timely manner. Responsible for end-to-end filing of New products (Actives / Fixed Dose Combinations / Nutritional supplements etc.) in CDSCO (Central Drugs Standard Control Organization), FSSAI, State FDA and other regulatory bodies. Filing application of ND/SND/FDC/Import Registration/Import license etc. on SUGAM portal. Track and interpret evolving regulatory requirements and assess their impact on ongoing projects. Collaborate with marketing and business development to support go-to-market strategies, portfolio expansion. Compliance & Change Control: Ensuring that manufacturing processes meet all relevant regulations and guidelines. Assessing and managing the regulatory impact of changes to manufacturing processes. Review of technical documents, Change controls Gap analysis for variation filing and maintaining product Life cycle. Collaborating with cross-functional teams, such as R&D, QA, and manufacturing, to ensure regulatory compliance. Audits and Inspections: Preparing for and supporting regulatory audits and inspections across various contract manufacturing sites. Ensuring that corrective actions are implemented in a timely manner with respect to Audit findings and that any necessary documentation is updated in a systematic manner. Others: Staying up-to-date with current FDA / FSAAI regulatory requirements and guidelines for APIs and Finished formulations. Provide regulatory support to QA-AC for IPC/CDTL/CDL testing Providing regulatory support for new product development. Key Result Areas: Manage proactive and professional delivery of results for the regulatory activities of all the products to support the business goals Ensure a high scientific standard and quality for all regulatory documents Monitoring and ensuring that both API manufacturing and Finished formulations production adhere to all applicable regulations. Preferred candidate profile B-Pharma or M-Pharma Minimum of 8 to10 years of experience in regulatory affairs in pharmaceutical industry, With at least 3 to 4 years in a managerial role. Strong understanding of pharma regulatory framework. Excellent communication and multi-tasking skills Location Mumbai HO / Regular visits to various Contract Manufacturing sites Department Regulatory Affairs

Role & responsibilities To review and understand technology of product from R&D scientist and coordinate, plan activities with all concerns personnel/ dept. for successful transfer of the products, Monitor tech transfer at site and update documents. To review and understand technology of product from CRO and coordinate, plan activities with all concerns personnel/ dept. for successful transfer of the products, monitor tech transfer at site and update documents. To resolve manufacturing issues/trouble shooting batches at manufacturing sites for the products which are commercialized. Monitoring of redeveloped formulations for quality improvement at manufacturing site. To develop new products as per requirement from business development team which involves pre-formulation studies, competitor product evaluation, prototype formulation development and stability batches manufacturing, stability charging and monitoring, preparation of R & D dossier etc with satisfactory stability studies. To work on quality improvisation and redevelopment projects at R & D To revise technical documents like MFR, FP Specifications after validation batches for changes, if any. To check/verify the documents like Process Validation Protocol and Process Validation Summary Report, APQR. To maintain and follow organizations rules and regulation. Preferred candidate profile 7- 10 Years of experience in R & D. Qualification: M. Pharm | B. Pharm Specific Skills: Experience of technology transfer from R & D to manufacturing site, should have work on multiple projects in parallel. Should have experience of new product development for solid, semisolid and liquid dosage forms. Perks and benefits Company bus service.

Role & responsibilities : Lead Regulatory Affairs department. Should be well versed with submission of Document in CTD/ACTD Format for Regulatory & ROW Market. Should be able to handle team. Preferred candidate profile Reputed Pharma background.

Role & responsibilities 1. Preparation of DMFs for regulated (US, EU) & ROW markets. 2. Preparation of lifecycle management submissions (amendments / revisions) for the filed DMFs. 3. Preparation of response to deficiencies from regulatory authorities & customers. 4. Review of the data for DMF preparation received from mfg. site and R&D and ensuring required corrections. 5. Coordination with cross functional teams for data / documents. Review of the DMFs & other submissions prepared by the team. Preferred candidate profile 1. Candidate should be M.Sc. Chemistry with 6-8 years experience OR B.Sc. - Chemistry with 8 years plus relevant work experience in a reputed pharma industry, preferably in API RA. 2. Should possess good knowledge of ICH guidelines and regional regulatory requirements for US, EU, Brazil & other ROW markets. 3. Should have individually handled DMF & deficiency response submissions. Should have strong analytical & interpersonal communication skills.

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.

Roles and Responsibility : To review and arrange required documents to corporate RA for dossiers, query response. To review artwork in artwork management system. R apply product permission, NOC for all manufactured product.R

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study. Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan and Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.

Role & responsibilities Responsible for driving Business development for all ROW and Institutional tender business with end-to-end tender management responsibilities Identify collaboration opportunities, Analysing markets and appointing distributers in the assigned territory Tender Participation in UNICEF/PAHO/WHO/IDA and other institutional agencies Tender management- tender preparation / documentation accuracy / timely submission of EOIs, RFPs and RFQ’s. Coordination with Alliance Management/ Regulatory / IP/ production teams for supply and documentation related needs Stock planning and inventory management in co-ordination with internal teams Ensuring OTIF (on time in full) delivery and documentation accuracy for tenders. Market research / sales data analysis/ analysing various tender related data sets to understand market trends and identifying the new portfolio opportunities for the organisation. Participate in stakeholder engagement meetings and weekly BRM’s. Visit trade fairs and countries as and when necessary If you interested, please share your updated resume to jagadees.komiri@glandpharma.com

Elevate Your Career with us, we're Seeking Masterminds to Drive Excellence! Evolet Healthcare Pvt. Ltd. is hiring for the position of Sr./Executive- Drugs Regulatory Affairs. Job Description: Having experience in dossier compilation (CTD & ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. Controlling the whole process of registration products from the beginning till the end. Evaluation of Bioequivalence and Clinical Trials (preferably). Required Candidate profile: Having knowledge of ICH guideline with relevant 1-5 years of experience. Having experience in registration any CIS, ASEAN, LATAM and AFRICAN countries. To be flexible for travelling and meeting with manufacturing plant representatives, which located out station. Must have excellent communication skills Must have excellent in analyzing skills Excellent in accuracy and focus Self-motivated and enthusiastic Perks and Benefits: Health Insurance Shuttle facility, Fix office timing, Career growth training & development

Role & responsibilities B.Pharma / M.Pharma candidates with 12--15years experience in Regulatory Affairs for Asia & Africa, CIS markets & ROW market wrt to Compilation of dossiers in CTD, eCTD & national ,Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for variation filing and maintaining product Life cycle. Preferred candidate profile Reputed Pharma background

Looking for International Business / Sales / BD / EXPORT Manager / Sr Manager for PHARMACEUTICALS EXPORTS. (B2B) Person will be responsible for Export / International Marketing / Sales for Pharma Formulation for ROW Markets. Various Countries Location-Pune Corporate Office (F.C. ROAD). This is a Office Based Job (Pune), Profile : Find distributor for MEDICINES in various countries Study EXPORT DATA , TRADE LEADS , B2B SITES Co-ordination with client and factory for timely delivery of goods. Sales & Marketing includes implementation of planned activity to generate business and to meet the sales targets. The person should be having experience of 8-12 years in a reputed pharmaceutical formulation company for the respective region. International business Development experience includes approaching and appointing foreigN AGENT. Coordinate with Regulatory Department to ensure proper dossier submission and getting MA. Required Candidate profile Good Communications Skills Honest, Hard Working Growth Mindset (Important) Ambitious & Positive Thinker 8-12 years of experience in Pharma Formulation Exports. Proficient English Writing / Speaking (Mandatory) Computer proficiency in MS Office, Excel, e-mail and internet functions PLEASE APPLY WITH PROPER COVERING NOTE at info@vekocare.com . We are fastest growing company in India, & have vacancies across different areas in Pharmaceutical Manufacturing / Sales operation. Even Junior Candidates with relevant exposure can contact us .

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

UpMan Placements is inviting applications for an exciting career opportunity with one of our esteemed clients from the Pharmaceuticals industry. Role : Senior Manager RA Location : Nagpur / Mumbai Reporting To : Director BD Role Requirement: Regular interaction and close co-operation with R&D, BD, Production and Logistics Responsible for the dossier filling & query responses of EU, Brazil, Canada & Row market Role Responsibilities: Develop and execute regulatory strategies to ensure timely product approvals. Preparation, review & submission of ECTD/CTD dossier as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for pharmaceutical products Preparation, review & submission of dossier as per DCGI requirement for submission in CDSCO Preparation, review & submission of techpack as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for Nutraceutical products Query response raised by (MoH/Customer) to EU, Regulated, and Emerging & ROW of Pharma & Nutra products Documents review QQF, Change control, specifications, Commercial specifications, artworks Process Validation Protocols & Report, Hold time study protocol & report, NDMA reports, Photo stability reports, Elemental reports, Risk assessment, Out of Specification. Co-ordination with external & internal clients. Updation and maintenance of database of dossier status. Fulfil requirement for site registration and GMP clearance/approvals Experience and Background: Bachelors or Masters degree in Pharmacy, Life Sciences, Chemistry, or a related field. 12+ years of experience in regulatory affairs within the pharmaceutical industry. Proven track record of successful regulatory submissions and approvals. Required Skills: Strong knowledge of global regulatory frameworks (FDA, EMA, MHRA, WHO, etc.). Excellent documentation, analytical, and problem-solving skills. Ability to interpret and apply regulatory guidelines and requirements. Effective communication and negotiation skills for interactions with health authorities. Strong project management and leadership abilities. Interested candidates can connect with Vanita at 7861882495 or email at vanita@upman.in

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.