119 Ra Jobs - Page 3

At least 4 years of experience in the BCM field High level of English - a MUST Project management skills a MUST Strong PC skills (MS Office, Word, Excel, PowerPoint, etc.) – a MUST Bachelor’s Degree in business management, computer science, engineering, or related field. Associate Business Continuity Professional (ABCP) certification or higher from the Disaster Recovery Institute International (DRII) or other equivalent industry standard. Familiarity with ISO 22301 standard including implementation experience Willingness to travel and support off-hour on-call if required – a MUST Personality traits: Must have a self-starting, driven, assertive and positive attitude Demonstrates effective problem-solving skills Excellent attention to detail Good presentation and documentation skills Ability to perform in stressful situations Excellent interpersonal and customer communications skills, the candidate must demonstrate and ability to motivate and influence management and other staff members to maintain an overall business continuity capability that will satisfy the business needs. Must be able to interface and coordinate work efficiently and effectively with business partners in remote locations Ability to work with global team Ability to perform multiple tasks simultaneously Excellent organizational skills, be comfortable dealing with individuals at all levels of the company

About Company ReNew is a leading decarbonization solutions provider and the first Indian clean energy company to list on Nasdaq (Nasdaq: RNW). With 16.3 GW of commissioned and pipeline utility-scale projects, we are a global company with strong Indian roots. Founded in 2011, ReNew is at the forefront of fighting climate change by offering decarbonization solutions through utility-scale wind and solar offerings, green hydrogen, carbon markets, and energy storage. ReNew has been a pioneer in leveraging digital technologies to accelerate the transition to green energy and address the unique requirements of the B2B segment in India, where we are the market leader. Our mission is to play a pivotal role in meeting India’s growing energy needs in an efficient, sustainable, and socially responsible manner. ReNew is the world’s first clean energy company to be recognized as a Lighthouse by the World Economic Forum. In 2023, we were recognized among ‘Top 15 Climate Tech Companies to Watch’ by the MIT Technology Review. We are a recipient of the Sustainable Market Initiative’s Terra Carta Seal. The COP28 UAE Presidency presented ReNew the ‘Energy Transition Changemaker’ award for developing and deploying the country’s first round-the-clock power project. ReNew’s solar and wind energy projects currently contribute to 1.9% of India’s power capacity and are spread across 150+ sites and 18 Indian states. We have helped prevent 0.5% of India’s total carbon emissions and 1.1% of India’s total power sector emissions, in addition to generating around 130,000 jobs over the past decade Job Description Build and maintain strong working relationships with key government offices including GEDA, CEIG, GERC, Secretariat, and relevant Ministries for daily coordination and strategic engagement. Keep abreast of Renewable Energy (RE) policy developments at both State and Central levels and provide insightful analysis to internal stakeholders. Identify and pursue business development opportunities under segments such as: STU-connected projects Open Access (OA) Commercial & Industrial (C&I) initiatives Engage with regulatory authorities and policymakers to advocate for the introduction and/or amendment of favorable RE sector policies. Coordinate with departments at GETCO, GUVNL, SLDC, and DISCOMs to ensure timely processing of connectivity-related documentation and regulatory compliances. Serve as the liaison between internal business teams and external regulatory bodies to streamline approvals and minimize delays. Provide timely updates on regulatory changes, risks, and opportunities impacting current or upcoming RE projects in the region.

Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTDs and RA dossiers. Conduct document reviews to ensure compliance with drug regulatory affairs requirements. Provide expertise on dossier preparation, drug regulatory affairs, and related matters. Collaborate with cross-functional teams to achieve project goals. Ensure timely submission of regulatory documents to relevant authorities. Desired Candidate Profile Bachelor's degree in Pharmacy (B.Pharma) from a recognized institution. 3-5 years of experience in pharmaceutical industry with a focus on drug regulatory affairs. Strong understanding of CTD, Document Review, Dossier Preparation, and RA processes.

GCS Medical College Hospital & Research Centre is looking for Executive - Quality 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.

We are looking for a Regulatory Affairs Professional for a leading pharmaceutical company based at Chennai location. Regulatory Affairs, RA ANDA, Product Lifecycle, Preparation & Submission, US Market, Formulation, Solid Orals or Injectables. Interested Candidates share your updated resume with srinidhi@bvrpc.com

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

Role Description This is a full-time, on-site role located in Ahmedabad for a Regulatory Affairs professional. The role involves preparing and reviewing regulatory documentation, ensuring compliance with regulatory requirements, coordinating regulatory submissions, and staying updated with evolving regulatory affairs. The candidate will work closely with cross-functional teams to support product registrations and regulatory submissions, ensuring adherence to relevant guidelines and standards. Qualifications Experience in Regulatory Documentation, Regulatory Compliance, Regulatory Requirements Knowledge of Regulatory Affairs and Regulatory Submissions in Europe / ROW / Emerging Market Strong attention to detail and excellent organizational skills Ability to work effectively in a team and coordinate with various departments Excellent written and verbal communication skills Familiarity with pharmaceutical industry regulations is a plus Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field Experience Europe Market - 5-8 Yrs Exp ROW/Emerging Market - 4-12 Yrs Exp Interested candidates can share there resume over mail on krupagohil@unisonpharmaceuticals.com

Job Summary: The candidate 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. Policy Support: Assist in the development and implementation of drug pricing policies and strategies. Qualifications: Education: Bachelors degree Experience: Experience in pharmaceutical pricing, regulatory compliance, or related fields.

Female B.Pharm / M.Pharm with 4 to 6 years of experience in Regulatory Affairs. Dossier Preparation in CTD/ACTD/Country Specific Formats. Re-registration and Renewal Application. Variation Application, Queries Handling, DMF Activity & Artwork Review. Required Candidate profile Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan & Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder, Gel & Cream, Injections, Syrup, Oral Drops Perks and benefits Negotiable - Depending Upon Candidate & Experience

TASEC Limited is looking for Executive / Senior Executive - Quality 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.

Role & responsibilities : Department : Regulatory Affairs , API Industry Designation : Assistant Manager Qualification : Msc in Chemistry Experience : 7 years Job Description : 1. Hands-on experience on New Drug Master File / Active Substance Master File to various Agencies (US, Europe, Health Canada, Japan, etc.,). 2. Life cycle maintenance to Drug Master File / Active Substance Master File to various Agencies (US, Europe, Health Canada, Japan, etc.,). 3. Responses to queries received from various Agencies. 4. Customer support for their ANDA approvals in various markets. 5. In change management system with respect to regulatory perspective. Please share resume to ramya_n@hikal.com

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.

Accountabilities Act as a resource on regulatory matters with regard to product changes. Collaborate to prepare and organize forums and gatherings with government officials to exchange ideas and information on business activities and potential legislation that may affect the organization. Help ensure that the organizations interests are represented and protected in legislative proceedings and in the development of market rules and procedures. Participate as part of a team to develop and maintain policies and programs to ensure awareness of government legislation and regulatory issues that affect the organization. Independently solve moderately complex issues with minimal supervision, while escalating more complex issues to appropriate staff. Other duties as assigned Qualifications Minimum Qualifications Bachelors degree in a related field or equivalent experience Minimum requirement of 3 years of relevant work experience with Public offices liaising in the Government departments of Andhra Pradesh. Preferred Qualifications Overall 7-12 years experience in a Govt Liaising role Certification in public law and proven experience of working on approvals, legislations in forums with Government officials in a manufacturing environment . Willingness to be based in a manufacturing site at Krishnapatnam Previous experience of working in close coordination with plant officials on Government related issues of the plant .

Group Purpose Global Regulatory Policy and Intelligence engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important Regulatory policy issues aligned with Amgen’s goals and priorities. Regulatory Intelligence for the GRAAS organization enables fast, efficient global filings by effectively monitoring, analyzing, and communicating regulatory requirements to regulatory strategy leads and others involved in the delivery of regulatory submissions and approvals. Coordination of change management activities in response to major changes in regulation also falls within the remit of this organization. Job Summary Performs monitoring and analysis of the global regulatory landscape according to defined plans and priorities and delivers agreed regulatory intelligence outputs. The Technology Systems Manager will be responsible for creating, developing, and maintaining a comprehensive databases and systems to facilitate optimizing data resource platforms and systems to collect and disseminate relevant regulatory information to internal stakeholders, ensuring timely awareness and compliance. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs and intelligence. Key Activities Facilitates and supports the tools and platforms utilized to prepare regulatory intelligence outputs that guide the successful development, submission and approval of Amgen products worldwide. Uses internal and external contacts, tools and systems to gather regulatory intelligence Applies professional skills and experience with advanced tools to summarize and contextualize regulatory intelligence information and identify trends in agency feedback Effectively communicates regulatory requirements to Regulatory Affairs staff Continually seeks opportunities to improve the usefulness of regulatory intelligence outputs and the effectiveness of tools and systems. Works with limited supervision according to predefined regulatory intelligence workplans Applies tools and systems to deliver agreed intelligence objectives Communicates progress and escalates issues impacting delivery of intelligence outputs Provides suggestions for improvement of processes, systems and tools employed within the function. Knowledge and Skills Basic: Regulatory intelligence monitoring, analyzing, and interpreting global regulatory developments to ensure compliance and inform strategic decision-making. Knowledge of regulatory agency guidelines and procedures (major and non-major markets) Knowledge of regulatory intelligence systems and platforms Understanding and application of aspects of global and local regulatory process Project management skills Presentation and interpersonal communication skills Preferred: Global Regulatory Intelligence monitoring experience Education and Experience (basic) Doctorate degree, OR Master’s degree and 3 years of directly related experience. OR Bachelor’s degree and 5 years of directly related experience, OR Associate’s degree and 10 years of directly related experience Education and Experience (preferred) A bachelor's degree in life sciences or a related field; advanced degrees may be preferred. A minimum of 5 years of experience in regulatory affairs, with at least 3 years in a regulatory intelligence role within the pharmaceutical, biotechnology, or medical device industries. In-depth knowledge of global regulatory frameworks and guidelines, such as those from the FDA, EMA, and other health authorities. Strong analytical and problem-solving skills, with the ability to interpret complex regulatory information and provide actionable insights. Excellent communication skills, both written and verbal, to effectively present information to diverse audiences. Proficiency with regulatory intelligence databases and software tools.

We are looking for Regulatory Affairs - Officer / Sr. Officer handling Reg, CIS, Africa and Asia and will be based at Juinagar, Navi Mumbai. Roles & Responsibilities: 1. 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. 2. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. 3. Regulatory Compliance and Updates: Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. 4. 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. Education: B pharm and MBA (Preferred) Desirable Skills & Competencies: Strong communication skills for effective client and team interactions. Excellent negotiation skills to close profitable deals. Strategic thinking for market expansion and business growt Interested candidates can apply or mail your resume. If you have good references you can share - Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd vaibhavi.b@titanpharma.com

Prepare CTD dossiers for regulated markets and other markets as per country specific guidelines. Attend to various queries raised by the importing countries wrt to Co.products & dossiers Coordinate with factory Required Candidate profile 1-3 Years Experience In Regulatory Affairs for formulations Excellent communication skills both written and verbal

To prepare Standard Operating Procedures of all departments. To review batch manufacturing records protocols and reports of all Active Pharmaceuticals Ingredients and Intermediates to support DMF / FILING. Follow quality assurance systems as per cGMP guidelines. To ensure that all manufacturing operations at the location comply with ICH Q7 system, documentation and records. To follow a system for releasing or rejecting all APIs. To follow up a system for releasing or rejecting intermediates for use outside the control of the manufacturing company. To follow a system to release or reject RM, Intermediates, packing and labeling materials. To perform product quality review. To prepare product labels and establish a system to control issuance of labels. To review raw data of analysis before release of the batch. To support Asst. Manager / Officer for Q.A activities like qualification, validation, calibration, and area monitoring. To prepare documents for customer questionnaires and support. To prepare, review and respond to the Regulatory Query. To fill the customer vendor questionnaire as per customer requirement & provide VQ related declaration. To prepare & review the DMF as per the pharmacopeia & customer requirement. To Submit the DMF to the Regulatory Authority as per the Regulatory requirement. To prepare & review declaration as per customer vendor questionnaire requirement. To perform Nitrosamine risk assessment as per the guideline requirement. To perform Genotoxic risk assessment as per the guideline requirement.

Role & responsibilities 1.Ensure proper documentation and fulfillment of statutory requirements with regards to various FDA authorities. 2. Collect information from various departments and prepare DMFs, Dossiers, amendments and supplements etc 3. Submit them to the pertinent regulatory authorities within a specified time frame to get approval. 4. Respond to queries as they arise and ensue that regishation/approvals are $anted without delay. 5. Coordinate customer and reeulatorv audits. 6. Provide compliance to customer complaints by coordination with marketing department. 7. Keep up to date of national and intemational legislations, guidelines (available on websites) and customer practices and concemed departments about the same. 8. Keep up to date with a company's product range. 9. Ensure that a company's products comply with the current regulations. 10. Formulate strategy for all regulatory submissions. 11. Participate in regulatory and customer inspections, review audit reports and submit compliance report to regulatory agency. 12. Maintain approved applications in compliance with appropriate guidance 13. Identifling the tlpe of changes & submit them as per country guidelines (life cycle management). 14. Monitor progress of all registration submissions country-wise and product-wise.

Role: Regulatory Affairs Canada Job location: Pune, Wakad Experience: 1-4 Years JD : 1. Experience in Canada market is required 2. Involved in Dossier preparation, Submission, Compilation of NDS/ANDS, Query Response for all dosage forms. 3. Modulewise documents review in line with eCTD guidelines 4. Responses for screening deficiencies. 5. Gap Analysis 6. Should have good knowledge and understanding of ICH and ANDS guidelines. 7. Hands on experience for review of various documents such as specifications, method of analysis, analytical method validations, product development reports, stability protocols etc. 8. Knowledge of DocuBridge software is preferred. If relevant and interested, pls share your resume

- Assist in preparing and reviewing regulatory submissions for nail polish products, including product dossiers, safety data sheets, and labeling. - Support product registration and internal audits. - Collaborate with R&D, QA, and Marketing teams. . Required Candidate profile - Bachelor’s degree in Regulatory Affairs, Pharmacy, Chemistry, Cosmetic Science or related field. - 1-2 years of experience in regulatory affairs, preferably in the cosmetics or nail polish industry

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.

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. Policy Support: Assist in the development and implementation of drug pricing policies and strategies. Qualifications: Education: Bachelors degree in Pharmacy Experience: 2-6 years in pharmaceutical pricing, regulatory compliance, or related fields.

Roles and Responsibilities Should handle a team of 4-10 members. Must have experience into formulations US - ANDA/NDA and EU Generic/Hybrid applications. Should be familiar with oral solids and parenteral dosage forms. Should familiar with pre and post approval regulatory activities. Should handle the customer and Agency queries. Should handle other regulatory activities based on organization need. Should support plant RA activities and other CFTs as needed. Desired Candidate Profile Perks and Benefits

The Regulatory Data & Systems Senior Associate will be responsible for interpreting and executing business requirements, based on a combination of industry best practice and Amgen regulatory processes. This role involves optimizing complex data systems supporting the health authority submission process, while ensuring compliance with regulatory regulations and guidance. The ideal candidate will have a strong background in system analysis and data science/AI in a regulated industry. Roles & Responsibilities: Data Administration/AI: Optimize and maintain the organization's complex data models, ensuring they are integrated, efficient, and compliant with regulatory requirements. Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices. Project Coordination Assist in planning, tracking, and executing departmental projects and initiatives. Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates. Required Knowledge and Skills: Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors. 5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies. Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner. Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction. Familiarity with GxP requirements and systems validation. Life Sciences, Biotech or pharmaceutical industry experience. Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault Familiarity with global regulatory processes and standards. Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment. Basic Education and Experience: Bachelor’s degree and 2 years of directly related experience Associate’s degree and 6 years of directly related experience High school diploma / GED and 8 years of directly related experience Preferred Education and Experience: Practical experience with regulatory data standards, such as IDMP 5+ years’ experience in data management, machine learning, or related fields

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.