119 Ra Jobs - Page 4

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Any job assigned by immediate supervisor/HOD Preferred candidate profile Experience required - Pharma API background Perks and benefits As per industry

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Global Calcium is looking for an experienced Manager - Regulatory Affairs with expertise in DMF & CEP filings and global regulatory submissions. If you have a passion for ensuring regulatory compliance and working with global health authorities, we want to hear from you! Key Responsibilities: DMF & CEP Filings: Prepare, review, and submit Drug Master Files (DMFs) in eCTD/NeeS format for USFDA, EU, and other markets. Handle amendments, annual updates, and regulatory deficiency responses. Regulatory Submissions & Compliance: Collaborate with R&D, Quality, and Manufacturing teams to compile technical data while ensuring adherence to GDP & global regulatory guidelines. Regulatory Communication & Strategy: Act as a liaison with regulatory authorities (USFDA, EU-GMP, TGA, etc.) and provide guidance on compliance strategies. Audits & Documentation: Support regulatory inspections & audits, ensure all regulatory documents are updated, and train internal teams on submission processes. Qualifications & Skills: Education: M.Pharm / B.Pharm / M.Sc. in Pharmaceutical Sciences, Regulatory Affairs, or Chemistry. Experience: 08+ years in Regulatory Affairs, with expertise in DMF & CEP filings. Key Skills: Regulatory guidelines, documentation, stakeholder management, analytical thinking, and communication skills. Why Join Us? Work in a globally recognized organization in the pharmaceutical industry. Contribute to key regulatory approvals across international markets. Collaborate with a team of experts in a dynamic environment. Interested candidates can send their resumes to: ramakrishnar.r@globalcalciumpharma.com Know someone who might be a great fit? Share this opportunity!

Regulatory Functional: Compilation of dossier for ROW market as per the country specific requirements (from Module-1 to Module 5) Ensure compliance to county specific regulatory requirements (i.e., Africa, ASEAN, CIA, Gulf, Asia pacific, Latin America) ¢ Ensure labeling compilation as per the country specific requirements ¢ Review of DMFs of complex peptide drug substances ¢ Post approval activity, variation filing (Major and Minor) as per change proposal recommend by the manufacturing site or client ¢ Experienced with handling drug device combination regulations and understand the requirements for submission in line country specific requirement (Prefilled syringes and disposable pens) ¢ To assure consistency and adequacy of submissions in line with current regulatory requirements/expectations ¢ Ensure timely response to the deficiencies received from the agencies ¢ To communicate & coordinate with different stakeholders within the organization/ third party contract manufacturers to resolve any delay in submissions ¢ Life cycle management of products to include renewals, reviewing & approving the change controls and ensures product continuity through filing and timely approvals of variations. Support the continuing activities through coordination with various stakeholder ¢ Approval package compilation and provides support for lunching of the approved product

To assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials.

Job description Coordination, implementation, maintenance of QMS as per ISO13485 Prepare and Control of QMS Documentation and liaise with external parties on matters relating to Quality Systems. Review Post Market Surveillance records & reporting Required Candidate profile Candidate must have worked on regulatory part of diagnostics or IVD Must have experience is CDSCO Should be from lifesciences background CAPA, OOS knowledge is must

? Role – Right Angle Architect The CTRM Consultant is responsible for identifying and defining the business needs of their clients and stakeholders, and helping to determine solutions to meet business needs or resolve business problems. This work is typically within Commodities Trading business area. JobDescription 10+ years’ experience of Right Angle (preferably v15 or higher) with Trading background (starting from Deal Capture, Contracts, Scheduling, Risk, Invoicing & Accounting) Understanding of Trading Domain within Oil and Gas or Utilities Domain. Knowledge of the technology landscape in Architect capacity including current and future developments and the most commonly available products and integrated solutions. Ability to develop RA customization; in both .NET & PB. Ability to integrate RA with Crystal Report or SSRS is a plus Any hands-on Azure Tech Stack experience like Azure Integration Services, Azure Dev Ops, MS Power Platform will be a plus. Work experience in an Architecture, Design, Development role with direct exposure to complex IT implementation projects Ability to take a systematic and analytical approach to problem solving and pay close attention to detail. Leading stakeholder management activities and help practice grow Business. Should possess excellent communication Skills as should be able to manage expectations with Client IT Managers /Architects.

Coordinate, compile regulatory documentation of filing activities/post approval changes for submission to regulatory authorities Approval with all relevant regulators USFDA Formulate RA standards, policies to ensure that regulatory compliance Required Candidate profile Must be from Life Sciences, have experience with USFDA, Compliance, ISO 13485, basic requirements of EU guidelines, medical device related regulations its requirements for approval, change management

Job Description: Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per EAEU 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.

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) Executive for them. The job location is in Vadodara (Gujarat). Qualification: B.Pharm/M.Pharm Experience: Min 4 yrs 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

Green Earth Exim India Pvt. Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Career County is looking for LEGAL EXECUTIVE to join our dynamic team and embark on a rewarding career journey. Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.

1Preparation of regulatory submission & dossier(ACTD, CTD) 2Ensuring compliance with domestic & international regulatory requirement 3Liaison with regulatory auth.for approval&certification 4Managing all RA-related activities for both domestic&export Required Candidate profile Candidates should be of Pharmacy Background. Knowledge of all RA activities Ability to work independently

Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Associate Qualifications: BCom Years of Experience: 1 to 3 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model – powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeAbility to effectively and efficiently conduct the process of screening individuals, entities, or transactions against lists of sanctioned or restricted parties. Sanctions screening involves using specialized software, understanding relevant regulations, and maintaining a proactive approach to mitigate the risk of engaging with sanctioned entities. What are we looking for? Collaboration and interpersonal skills Problem-solving skills Strong analytical skills Numerical ability Ability to meet deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BCom

Role & responsibilities 1. Regulatory Submissions and Approvals: Prepare and submit dossiers for product registrations in ROW, Africa, LATAM, CIS, and ASEAN markets, ensuring adherence to country-specific guidelines and requirements. Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for regulatory submissions. Liaise with regulatory authorities and consultants in these regions to facilitate product approvals and resolve any queries or deficiencies. 2. Compliance and Documentation: Ensure compliance with local regulatory requirements, guidelines, and international standards (such as WHO, ICH, or country-specific regulations). Maintain accurate and up-to-date records of regulatory documents, approvals, and communications. Monitor and ensure compliance with post-marketing regulatory requirements, such as periodic updates, renewals, and reporting obligations. 3. Labeling and Packaging Compliance: Review and approve labeling and packaging materials to ensure they meet the regulatory requirements of each country in the assigned regions. Coordinate changes in labeling as per the updated guidelines and regulations from local health authorities. 4. Product Development Support: Work closely with product development teams to ensure regulatory requirements are considered during product formulation and development. Provide regulatory advice on technical issues related to injectables, including formulation, packaging, and stability studies. 5. Regulatory Intelligence: Stay updated on changes in regulations, guidelines, and standards in the ROW, Africa, LATAM, CIS, and ASEAN regions. Communicate any changes or updates in regulatory requirements to relevant departments and ensure compliance with new regulations. 6. Communication and Coordination: Act as a point of contact between the company and regulatory bodies in the assigned markets. Coordinate with external partners, consultants, and distributors to facilitate regulatory submissions and product launches. 7. Cross-functional Collaboration: Collaborate with Quality Assurance, Manufacturing, and R&D teams to ensure that regulatory requirements are met at every stage of product development and manufacturing. Support in audits and inspections conducted by regulatory agencies and provide necessary documentation and information. 8. Product Registration Lifecycle Management: Manage the entire lifecycle of product registrations, including initial submissions, renewals, variations, and amendments. Ensure timely submission of regulatory documents to maintain product approvals and licenses. 9. Risk Management and Problem-Solving: Identify potential regulatory risks and devise strategies to mitigate them, ensuring uninterrupted market access for products. Provide solutions and regulatory strategies to resolve any issues or challenges related to regulatory submissions. Preferred candidate profile Must have experience in Injectables dosage forms. Perks and benefits

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.

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of building regulatory dossiers of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.You will be expected to collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? Life Sciences Regulatory Services Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Agility for quick learning Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications Master of Pharmacy

Academic Background and Experience: Academics - M.Sc. in Chemistry Experience 13 to 25 years Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills Role & responsibilities Review documents from various departments to compile regulatory submissions. Oversee Drug Master Files (DMFs) for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMFs to ensure regulatory compliance. Coordinate with cross-functional teams (CFT) to address deficiencies and feedback from regulatory authorities and customers. Conduct CFT meetings to ensure timely responses to regulatory deficiencies and customer inquiries. Provide regulatory guidance to product development teams and attend Technology Transfer Meetings to support compliance. Maintain and update regulatory databases, ensuring accuracy and completeness. Review and approve regulatory submissions and related documents prepared by team members for compliance. Manage change controls and other relevant documents, including approving them in the HOD's absence. Respond promptly to technical queries from regulatory bodies and customers. Interested candidates share their CV to dinesh.baratam@msnlabs.com Please mention subject line "API RA Manager/AGM profile"

Candidate should be M.Pharmacy with 18-20 years of experience in Regulatory Affairs department from a reputed formulations manufacturing Industry. Regulatory Strategy and Compliance: Develop and implement regulatory strategies for product formulations to ensure compliance with all applicable regulations and guidelines. Stay updated with changes in regulatory environments and proactively assess their impact on product formulations. Regulatory Submissions: Oversee the preparation, review, and submission of regulatory documents, including INDs, NDAs, ANDAs, CTDs, and other regulatory filings. Ensure timely submissions and approvals by regulatory authorities such as FDA, EMA, and other global agencies. Cross-Functional Collaboration: Work closely with R&D to ensure that regulatory requirements are integrated into the product development process. Collaborate with quality assurance and manufacturing teams to ensure compliance during product formulation, testing, and production. Regulatory Guidance and Training: Provide regulatory guidance and training to internal teams to ensure understanding and compliance with regulatory requirements. Serve as the primary point of contact for regulatory matters related to formulations. Regulatory Intelligence: Monitor and analyze regulatory trends, changes, and advancements in the industry. Communicate relevant regulatory updates and implications to internal stakeholders. Documentation and Record Keeping: Maintain accurate and comprehensive records of regulatory submissions, correspondence, and approvals. Ensure that all regulatory documentation is up to date and readily accessible for audits and inspections. Regulatory Agency Interactions: Manage relationships and communications with regulatory agencies. Prepare for and lead regulatory agency meetings and inspections related to formulations.

RA Ensure compliance with regulations,prepare & submit regulatory filings, & maintain existing registrations,ensuring API & related products meet legal requirements.Must Knowledge of Dossier Making,Product Permission,Application Permission,ROW Market

Regulatory Strategy & Compliance US, FDA, MDR Documentation & Submissions Regulatory Monitoring/ Reporting, Submission of UDI to GUDID/EUDAMED Regulatory Audits and Inspections CAPAs, NCs closure Navigating regulatory requirement for CDSCO, US FDA Required Candidate profile BE/BTech- Mech. min. 3+ years of exp. in regulatory affairs with medical device industry, strong understanding of U.S. FDA and European regulatory requirements, EU MDR 2017, ISO 13485, RAC, CDSCO.

Assist with regulatory compliance tasks for the firm. Research and stay updated on relevant financial regulations. Review client documentation and ensure adherence to KYC/AML procedures. Prepare reports and presentations on compliance topics. Maintain accurate records of compliance activities. Skills Strong attention to detail and accuracy. Ability to understand and interpret complex regulations. Excellent research and problem-solving skills. Strong work ethic and commitment to ethical practices.

Cross-Functional Collaboration: Collaborate with R&D, manufacturing, and marketing teams to integrate regulatory considerations into the product development and commercialization processes. Regulatory Submissions: Oversee the preparation and submission of all necessary regulatory new dossier filings, and variations, to relevant health authorities in the targeted regions. Market Intelligence: Monitor and analyze evolving regulatory landscapes and market trends to proactively identify opportunities and challenges. Stakeholder Engagement: Build and maintain strong relationships with regulatory agencies, industry associations, and key stakeholders to facilitate smooth regulatory processes. Team Leadership: Lead and mentor a diverse team of regulatory professionals, promoting a culture of excellence, compliance, and continuous improvement. Compliance Oversight: Ensure all regulatory activities adhere to internal policies and external regulations, managing audits and inspections effectively.

Candidate job profile Qualification degree B. Pharm or M. Pharmacy and minimum 3 years experience in dossier preparation (Cis & Latam Market). Job Description Dossier Preparation & Compilation

• Responsible for Regulatory filings for APIs and Intermediates and achieving registrations-DMF (US, Europe, Australia, Korea, Japan, WHO, other reg / non reg countries), CEPs. • Responsible for coordination of all Regulatory Query responses with agencies, regulatory related query responses with customers. • Ensure that all regulatory requirements for successful registration are addressed during development and validation – Specifications, Impurity profiles, Different regulatory requirements wrt impurities, starting materials, analytical and process validations. • Life cycle management of DMFs, Registrations -Annual reports, change updations • Support during regulatory audits. • Support QA function for product license requirements, different requirements with state and central agencies (CDSCO) -Written confirmation, Form 44 NOCs for new products etc • Review of supplier documentation for regulatory requirements