119 Ra Jobs - Page 5

Role & responsibilities - Review, compile and submit the Application dossiers (ANDA, MAA) to regulatory agencies like US-FDA, EMA, Health Canada, Australia and ROW countries. - Review and approve regulatory CMC documents being generated at R&D and commercial manufacturing facility such as development reports, BMR, BPR, Specifications, method validation reports, process validation reports, stability protocols, stability data etc. and ensure regulatory compliance. - Maintenance of the complete history of each Drug products (Filing history with agencies/customers, amendments).To coordinate in regulatory audits and provide regulatory support. - Coordination with internal and external stakeholders for regulatory filing related documentation. - Communicate the agency's comments/deficiencies to respective in house departments, prepare the response and submit it back to the agency. - Hands on experience of post approval variations and Annual reports. Preferred candidate profile Master of Pharmacy Perks and benefits As per Company Standards

• Ensure compliance with Stage Gate and Design QA procedures. • Coordination between different stake holders – R&D, QC, QA, RA, Project Management for effective Stage Gate reviews and clearances of Stages. • Review PDRs, Scale up reports including Lab Note books • Participate in designing DOE trials in line with Process • Review Scale up protocols, Exhibit protocols, Process Validation protocols and reports • R&D IPQA • R&D procedural compliances – Qualifications, Calibrations, RLD Management, Stability Management • Responsible for deviation, investigation related to R&D. • Responsible for specification/STP review. Review and clearance of Analytical Method Validations • R&D Documentation Management -Issuance and retrieval • Responsible for clearing Formulation Projects for Scale up and Exhibit batches.

Hiring for Jr. Executive / Sr. Executive for RA - API with 2 to 5 Years of experience.

KEY ROLES & RESPONSIBILITIES Work with team of onshore analysts to cover credit portfolio of corporates, UAE, GCC and international portfolio Preparing opinion based credit reports and financial models based on fundamental analysis for a set of assigned credits/companies The credit assessment process requires the following: Undertaking research and analysis of an entity through thorough assessment of its credit strengths and weakness and weighing its business and financial risk profile. Understanding the potential for sovereign support or parent support which would need to be factored into the credit assessments. Preparing a detailed credit assessment report and elaborately discuss the company profile and credit risk considerations. Preparing and updating detailed financial models encompassing financial analysis, capital structure analysis, calculation of key credit quality determinants and financial projections (upto 7 years). Determine and recommend ratings to the entity based on the internal rating framework and methodology. Regular interaction with client to discuss reports as well as workflow Support the client with any ad-hoc research requests including sector research Engage with client teams proactively and suggest new ideas to enhance client engagement Train new hires and mentor juniors in the team FUNCTIONAL & BEHAVIOURAL KNOWLEDGE Experience in deal financial modeling/ surveillance/ portfolio monitoring and credit analysis Good understanding of banking regulations, calculation of key credit metrics and capital ratios Reasonable understanding of banks internal systems PROBLEM SOLVING Identifies and resolves complex research issues and team problems Assist in solving complex problems related to financial modeling INTERACTIONS Works within own team and interacts with other related teams Communicates with internal & external clients and/or issuers as necessary

D ossiers Planning, Allocation, Execution and Monitoring for timely submission to health agency for obtaining product and company registration in LATAM, APAC and CIS markets. • Managing the work delegation to the Regulatory Team & careful monitoring of the monthly submissions, filling of variation & registrations • Review of Dossiers in CTD, ACTD & Country specific format • Responsible for Query response & filling of product variation to the different health authorities • Review of SPC, Labeling & PIL • Review of validation protocol for proposed commercial batch sizes • Obtaining Product / Company registration through monitoring the regulatory requirements, maintaining online database & product lifecycle management • CRM, Scientific & Corporate Communications along with management of internal / external customers and various health agencies • Experienced Site/product Audit of Ukraine, Kazakhstan, Uganda, Malaysia, Philippines. neetij@selectsourceintl.com

About The Role :: Job Title:Regulatory Control Analyst Corporate Title:Associate Location:Bangalore, India Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs Organization Deutsche Bank (DB) is committed to the highest standards of Anti-Money Laundering (AML), Sanctions & Embargoes, Anti-Bribery and Corruption (ABC) and Anti-Fraud & Investigations (AF&I) and wider Financial Crime (collectively referred to as Anti Financial Crime) prevention. The Management and all employees are required to adhere to these standards to prevent DB and our reputation from those who may intend to use our products and services for money laundering, bribery, corruption, fraud and/or Terrorist Financing (TF) purposes. AFC KYC COE Implement a dedicated Centre(s) of Excellence for the AFC element of the KYC file review, allowing customers to be reviewed once in review cycle. Below are some of the key principals . Achieve economies of scale through the creation of one functional team with sophisticated risk managers, under one global leader who is accountable for the AFC KYC file review and sign-off process. Ensure fulfilment of local regulations and regulatory expectations in an efficient, risk focused manner. Ensure sufficient resources to create and effectively maintain a follow the sun KYC file review aligned with ACO availability. Seek opportunities to geographically co-locate the CoE with respective 1LoD counterparties (i.e. align with the 1LoD Target Operating Model) to stimulate cooperation and strengthen the relationship What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy. Best in class leave policy. Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Review and approve client escalations for Remediation, Regular Review, New Product Extensions and Event Driven Reviews within the agreedSLAs Ensure the generated client risk rating is in line withexpectations & procedures. Assess the risk factors identified through the due diligence provided by client lifecycle management (CLM) Apply subject matter expertise judgment as to relevance and/or materiality of Escalation triggers; i.e., can the overall assessment bedefended Engage with appropriate BLAFC specialist team where further escalation is required e.g., local BLAFC, AFBC, Sanctions, BIUetc. Liaise with CLM to obtain additional information or request ACO to conduct additional research whererequired Ensure outcome and rational is clearly documented within the KYC systems and / or escalated for furtherguidance Ensure that KYC reviews undertaken are in line with the KOPs guidelines andprocesses Contributing to the wider globalKYCCentre of Excellence programme, identifying best practices Deciding on new or existing clients that are escalated or deciding to escalate further to Governance Forums for review. Defining and implementing strategic TOM in-line with local/regional/global standards and change programmes. Your skills and experience Skills: Ability to identify and manage financial crime risks arising from regular reviews, event driven reviews, new client adoptions and new productextensions Strong communication, organizational, and interpersonal skills with the confidence to engage and advise professionally and persuasively with stakeholders. Proven analytical skills, problem solving ability, and a control mindset paired with meticulous attention to detail. Able to raise sensitive or potentially contentious issues in a constructive manner to reach appropriate solutions. Deadline driven with the ability to multi-task and work in a fast-paced environment. Ability to handle time-sensitive projects while focusing on the quality of work delivered. Self-motivated and proactive team player who takes ownership of assignments, thrives in a teamwork-oriented environment, and works well under pressure. Ability to work with various stakeholders across all 1LoD and 2Lod and manage expectations, without impacting the quality output. Experience: Must be a graduate with any stream with at least 4-5 years experience in AFC or a related control related function within an international organization/bank in the Financial Services industry with extensive experience with the KYC process. People having a degree or diploma in AML/KYC will be preferred. A strong track record in risk and regulatory matters, ideally including: Good understanding of AFC risks and typologies in order to identify areas or instances of potential AFC risks and to address them appropriately. Experience of relevant regulations/laws and related circulars Financial Crime function expertise and should be considered a Subject Matter Expert (SME) in the Financial Crime area on relevant laws and regulations. Should be flexible with respect to work timings. Should be comfortable in working on MS Office tools using word and excel. How we'll support you Training and development to help you excel in your career. Coaching and support from experts in your team A culture of continuous learning to aid progression. A range of flexible benefits that you can tailor to suit your needs. About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

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

Roles & Responsibility: Dossier preparation/ review per country specific guideline/ CTD guidelines. Timely query response, submission to Distributor / MOH. Review of documents for their correctness and compliance with respective regulatory guidelines (as per country requirement). Preparation, review and release of artwork and sales order as per country approval. Variation documents preparation and filling as per country requirements. Timely dispatch of tender documents to country/ parties as per deadline. Preferred candidate profile : Regulatory Affairs experience is mandatory Should be able to review and interpret the country specific requirements. 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 counterpart in the countries.

Unison Pharmaceuticals, one of the fastest growing organization is looking for Multiple positions in Regulatory Affairs - Europe/ regulated Market for pre-submission and post-submission. Roles and Responsibilities Ensure timely authoring and submission of dossiers (Module 2-5) for regulated regions such as Europe, Australia, South Africa, New Zealand and Canada in the eCTD format including familiarity with publishing activities. Preparation and submission of documentation for post-approval applications (CMC and Administrative changes) such as Type IA/ IB/ II variations for Europe/UK, Level I/II/III changes for Health Canada, Renewals, and MAH Transfers. Work with submission teams and provide appropriate support for managing the lifecycle of product submissions, and authorizations. Assessment of change controls, defining the correct variation code and preparation of the variation packages as per the agreed timelines. Preparation of quality responses to the deficiency letters from various Clients/agencies within agreed time frame. Co-ordinate with various departments to obtain essential scientific data and documents required for dossier preparation and query responses. Evaluates proposed manufacturing and quality changes for impact to ongoing and existing filings and provides strategic regulatory support for optimal implementation of changes. Involve in review of source documents for in-house: product development report, specification (excipients, API and finished product), manufacturing batch record, analytical method, validation report, validation protocol etc. Actively participate in the evaluation of regulatory compliance of document/product/ process/test methods changes. Provide regulatory insights and support for contract manufacturing projects (CMO/CDMO). Preform gap analysis for extension of dossier to other territories as per country specific requirements. Identifies and communicates risks and issues impacting project progression. Assist in the development of Regulatory CMC strategies for assigned products and projects. Ensure product compliance with respect to approvals and regulatory requirements. Tracker Management: Update/Maintenance of database with regulatory submission and approval. Candidate(s) having previous exposure in EU dossier authoring, product life cycle management/variation and Health Canada filings are preferable. Core competencies: Strong technical understanding of ICH/EU/ANZ/Health Canada guidance's, time management skills, right first time approach, work with minimal supervision. Strong written and verbal communication skills. Interested candidates can share your resume on krupagohil@unisonpharmaceuticals.com

Key Responsibilities: Regulatory Strategy Development: Collaborate with cross-functional teams to develop and execute regulatory strategies for biological products, ensuring alignment with corporate objectives and regulatory guidelines. Regulatory Submissions: Prepare and submit regulatory documents, including CDSCO dossiers/queries, variations including scale-up changes, and annual reports, while ensuring accuracy, completeness, and timeliness. Regulatory Intelligence: Monitor and interpret regulatory requirements, guidelines, and trends related to biological products to inform decision-making and maintain compliance. Cross-functional Collaboration: Work closely with R&D, Clinical Development, Quality Assurance, and Manufacturing teams to support regulatory activities, resolve regulatory issues, and facilitate product development and registration. Regulatory Compliance: Ensure compliance with applicable regulations and guidelines, including those set forth by regulatory authorities such as the CDSCO, FDA, EMA, and other global agencies, throughout the product lifecycle. Regulatory Agency Interactions: Serve as a primary point of contact for regulatory agencies, participating in meetings, teleconferences, and regulatory inspections as needed to address inquiries and facilitate approvals. Product Labelling and Promotional Material Review: Review and approve product labelling, promotional materials, and advertising to ensure compliance with regulatory requirements and company policies. Regulatory Document Management: Maintain regulatory files and documentation in accordance with company procedures and regulatory standards, ensuring accessibility and traceability. Interested candidates can share CVS at sheetal.c@cielhr.com

Job Summary: The Executive at NPPA is responsible for monitoring, analyzing, and regulating pharmaceutical pricing. Key Responsibilities: Regulatory Compliance: Review pricing submissions from pharmaceutical companies and enforce compliance with pricing policies. Reporting: Prepare and present reports on pricing data, trends, and regulatory compliance for internal stakeholders. Stakeholder Engagement: Communicate with pharmaceutical companies, stakeholders, and consumer groups to address pricing issues and gather feedback. Policy Support: Assist in the development and implementation of drug pricing policies and strategies. Qualifications: Education: Bachelors degree in Pharmacy Experience: 4-6 years in pharmaceutical pricing, regulatory compliance, or related fields.

Greetings from BVR People Consulting!! Position: Regulatory Affairs - Formulation Designation: Executive or Asst. Manager Division: Injectable and Solid oral products Qualification: B. Pharm, M. Pharm and M. Sc (FULL TIME) only Years of Experience: 4 to 8 Years CTC range: 5 to 13 LPA. Job Locations: Bangalore ( Electronic City ) No. of Positions: 04 Job Summary: Compilation and submission of the dossier and query responses as per the EU/UK/ANZ /Israel/Belarus and Ukraine regulatory requirements within stipulated timeframe (for Injectable and Solid oral products ). Interaction with CFTs for product specific requirements and to attend product strategy meetings. Review of final data and technical documents received towards dossier compilation from API team, RnD, IP, PV, QA, Commercial, Packaging and Plant team. Compilation of labelling documents as per current EU/UK/ANZ/Israel/Belarus and Ukraine regulatory requirements. eCTD Publishing of dossiers in DocuBridge software. Product life cycle management for approved Europe products i.e. variation, Renewal and sunset exemption filings. Maintain product database, regulatory files, records and reporting systems. Timely updation and maintenance of RIMS database. Preparation and submission of high-quality national translations for National Phase. Post Approval and Pre approval NOTE: We are looking Notice period 01 month or immediate joiner. Interested Candidates should forward their resume to " ganapathi@bvrpc.com" and also Your Current CTC, Excepted CTC and Notice period. Thanks K Ganapathi Mob. No. 9600387468

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Must be aware of the latest country specific guidelines for ROW market and capable of planning and implementing, guiding, supporting, reviewing and finally approving the dossiers and implementing the other defined activities of the department.

"Regulatory Affairs Executive"(injectable) in the pharmaceutical industry is responsible for ensuring a company's drug products comply with all relevant regulations by preparing and submitting necessary documentation to regulatory agencies.

Dear Professionals,,! I am Sindhura C , from the Pharma Vertical of Masadir HR Services, an International Recruitment Firm. We have been retained by professionally managed organisation to recruit Regulatory Affairs (RA)Officer for them. The job location is in Vadodara (Gujarat). Qualification: B.Pharm/M.Pharm Experience: Min 1 yr Must Knowlede of Dossier Making,Product Permission, Application Permission If you are interested in exploring the above opportunity, kindly share your updated resume with me please. In case, if you are not interested, kindly feel free to refer your friends who may be interested in this. Looking forward to hearing from you soon. Thank you! Have a great day! Warm Regards, Sindhura C Associate| Global Talent Acquisition Operations | India Mobile/ WhatsApp : +91 6282564376 Email Id: sindhura.c@masadirservices.com www.masadirservices.com

To prepare and review Validation Master Plan (QMP, VMP, PVMP, CVMP and CSVMP). To follow the validation master plan.To prepare and review qualification and validation documents and execution as per protocol. Required Candidate profile Preparation&review of URS,FS,DS,DQ,RA,IQ, OQ&PQ & summary reports for Equipment, System&Utilities.Handling & storage of all quality document like BMR,BPR,log book, protocol & SOP throughout life cycle

Unison Pharmaceuticals, one of the fastest growing organization is looking for Multiple positions in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission . Role and responsibilities Responsible for preparing/reviewing various regulatory documents for Emerging markets (South East Asia, Africa, CIS, Latin America, Gulf Countries) such as, Dossiers in ACTD, CTD and in country specific format. Variation filling, renewal fillings, Query response, Site registration applications, Tender fillings. Legal Applications related to local FDA\CDSCO like FSC, COPP, Product permissions, WHO GMP inclusions. Responsible for coordinating with Cross functional teams for timely receipt of technical documents. To verify and approve all technical documents in line with current regulatory requirements. Regulatory assessment of CCN/Deviation for Impact assessment. Artwork development, amendments and maintenance without adversely affecting the business continuity to implement regulatory changes. Maintain various regulatory status. 2. Monitoring of product lifecycle as per regulatory requirement. 3. Literature search, data collection, evaluation to meet the requirement of above job responsibilities. Candidate should have detailed knowledge on: Regulatory requirements for submission of product dossiers. Registration samples submission in ROW countries. Candidate must have Good in written and verbal communications. Candidate must have basic knowledge of Microsoft Word, Excel & Power Point Interested candidates may also email their resume to maitrivakil@unisonpharmaceuticals.com

Hi, I am Nirmal from the Pharma Vertical of Masadir HR Services, an International Recruitment Firm. We have been retained by a professionally managed organisation to recruit Officer-Regulatory Affairs for them. The job location is Vadodara-Gujarat . Kindly find below the job description: Dossier Making Product Permission Application Permission If you are interested or know any suitable candidates kindly share your updated resume with me through Whatsapp 8608205815 . Looking forward to hearing from you soon. Thank you! Have a great day! Regards Nirmal Marimuthu Associate | Global Talent Acquisition Operations M: + 918608205815 E: nirmal.m@masadirhr.com