About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for a Senior Executive Sales & Receivable. Assisting Commercial/business team on regular interval for best business processes & ensure correct practices are followed. Co-ordinate with internal customers to update Finance views for distribution agreements. Validate Revenue accounted by the Commercial/Business Team in the system is correct as per the Sales/Depot reports received from Distributors. Reply to internal/external queries within 24-48 hours of receipt of queries. Preparation of Receivables reports to track overdue customers. Perform/review allocations/offset/contra entries in SAP. Ensure Invoice postings in the same month in case of stocks ship out & all related processes followed for correct revenue recognition from an IFRS15 perspective. Review customer reconciliation on a monthly/quarterly basis for balances and GTN items. Perform Margin & Other Reconciliation of API/FG and profit/revenue share/royalty models for distributors on regular intervals and update to Management on current status. Review monthly Deferred revenue release upon receipt of Stock and Sales report from Distributors for the International region. Processing of all types of revenue rebates with help of agreements/records. Regularly support commercial/cross-departments to follow Internal Control (Sox compliance) for revenue/receivable accounting functions. Ensure escalation if the queries are not addressed by Customer/ Internal customers within stipulated timeline. Assist auditors in providing support and documentation on internal processes for accounts receivable/revenue functions and completion of statutory audits on time. Ensure Commercial/Business units accrue for monthly expenses (distribution fees, commission, territory cost, etc.,) against sales without fail using the PO process or accrue through Finance. Continuously looking for areas of development/improvement regarding Sales/ AR functions & assisting team/ other members to follow rationale processes to improve the quality of work. Ensuring that Internal Controls (Sox compliance) procedures are properly followed as per process narratives by respective teams. We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Graduate/post-graduate with preferably Finance/accounting background. Knowledge, Skills & Experience: Significant experience in Sales & Accounts receivables function, especially in Revenue accounting, Sales reconciliation, AR audits, etc. Thorough understanding of SAP FICO and SD module. Excellent interpersonal, communication, organizational skills, and attention to detail. Good Analytical, reasoning skills and logical thinking. Ability to handle pressure situation, good understanding of IT systems. Aware about pharma operations like regulatory / manufacturing. Self-starter, result driven and a good team player. A positive and can-do approach , biased towards finding solutions and embracing change. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment.

The role of the Medical Office is to bring medical/scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: medical affairs, medical compliance, patient safety, clinical development and post marketing research and medical operations. This entails engaging and collaborating with healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data. What You ll Do: Work actively in risk management activities, including risk management plans, referrals, signal detection and medical writing to support product safety reviews and clinical evaluations. Work actively in identifying and processing signals for all ADVANZ PHARMA products as been assigned within the stipulated time. To prepare Signal reports (including PAS, DSR, SAR as applicable) and maintain the compliance and quality of signal detection. Act as a Safety contact point on all matters relating to Safety agreements with license business partners including the handling of confidential information and negotiation of the agreements with commercial and co-development partners. Coordinate the preparation and conclusion of SDEAs together with relevant internal and external parties. Track and maintain oversight on all assigned Safety agreements. To update SDEAs on a regular basis, coordinate in the completion of business partner responsibility tracker, to identify gaps in the templates and process, make appropriate changes if required. Act as a key contact point on all matters relating to SDEAs with internal stakeholders (e.g. Safety, Quality, Regulatory, Business Development, Supply, Commercial, Legal) as well as external business partners. Actively coordinate with all the internal and external stakeholders to ensure Pharmacovigilance and regulatory compliance. Involvement in pre and post action arising from PV audits and inspections Keeping abreast of changing PV requirements globally. Contribute towards continued improvement of safety systems and processes. Ensure all documentation is structured and maintained as required. Compliance with GPvP and company requirements, demonstrated through audits and inspections. Perform regulatory intelligence activities. Thrive in an entrepreneurial environment and take accountability for results. Embrace challenge and change, applying a growth mindset approach. Have a bias for action and fast decision making. Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity. Drive the spirit of One Team by working collaboratively across all business functions with an open, honest, and respectful cooperation. Contribute to making ADVANZ PHARMA a desired place to work. About You We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Tertiary qualification in any discipline within Life sciences or Pharmacy. Post-graduate qualification (e.g. Masters) in an industry relevant field. Knowledge, Skills Experience: Must have significant experience in Drug safety or Pharmacovigilance activities. Proven ability to analyze scientific data. Medical Writing experience (e.g. PSURs, Safety variations, RMPs, Clinical and Non-Clinical components of product dossiers). Experience in Compliance tracking (e.g. PSMF, safety databases) and Pharmacovigilance Audits. Open and adaptable to challenging environments. Ability to work with different Global culture and different time zones. Excellent attention to detail and innovative solution finding ability. Excellent communication skills. Ability to communicate clearly and concisely and use strong writing and verbal skills to communicate facts, figures, and ideas to others. A positive and can-do approach , biased towards finding solutions and embracing change. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment.

Select with space bar to view the full contents of the job information. Executive - Quality Systems Job Details | AdvanzPharma We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve the websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Reject All Cookies Accept All Cookies Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Andheri (East), IN, Mumbai 400 ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for an Executive- Quality Systems. Execute Complaints investigations in accordance with the defined procedures ensuring that: Complaints are raised in the system. Complaints are investigated to the required standard and that root cause is identified (leading to appropriate CAPA). Complaint s resolution is appropriately documented with supporting evidence. Liaising with CMOs and relevant stakeholders to ensure that complaints are investigated, resolved and closed in a timely manner. Interact with complaints reporter in the course of investigations and communicate the outcome of investigations accordingly. Follow up with CAPA owners to ensure that actions are implemented in a timely manner. To assist in executing Recalls as required. To assist in investigation of deviations when required. Creation of Quality related documentation (SOPs, Risk Assessments etc.) Carry out internal audits as required. Report Quality Systems metrics. Other activities as may be required, at the discretion of management. Thrive in an entrepreneurial environment and take accountability for results. Embrace challenge and change, applying a growth mindset approach. Have a bias for action and fast decision making. Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity. Drive the spirit of One Team by working collaboratively across all business functions with an open, honest, and respectful cooperation. Contribute to making ADVANZ PHARMA a desired place to work. We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Minimum Honors Degree in Chemistry, Pharmacy or Microbiology. Knowledge, Skills & Experience: Decent experience of working in a similar role within a pharmaceutical company. Ability to use eQMS (eg. TrackWise, Veeva Vault etc.) for Quality Systems management. Knowledge of ICH Q9, ICH Q10 and Eudralex- Volume 4 Good manufacturing practice (GMP) guidelines. Capable of working to deadlines & remain calm under pressure. Good working knowledge of MS Office. Well organised with logical & methodical approach to work. Excellent communication skills, both oral and written, to include senior management where escalation is required. A positive and can-do approach , biased towards finding solutions and embracing change. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment. The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on. But there s more to you and us than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package. *Please include a CV and Cover letter. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. These cookies are required to use this website and cant be turned off. 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The role of the Medical Office is to bring medical, regulatory, scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: global regulatory affairs, global medical affairs, global healthcare compliance, global patient safety and global clinical development. This entails engaging and collaborating with regulatory agencies, healthcare organizations, healthcare professionals and customers both internal and external - and generating and communicating relevant, meaningful, and impactful data, and securing and maintaining marketing authorizations across the ADVANZ PHARMA portfolio. In so doing, the Medical Office represents the voice of the patient in all matters; works to ensure that products and marketing authorizations are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for Specialist Regulatory Affairs LCM Strategic Growth Products. Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements. Provide supportive role to New Product Introduction team during Translation and Product label/mock up finalization to secure necessary approvals. In case of DCPs, responsible for managing the national phase procedure with respective health authorities. Become the primary point of contact for Health Authorities following grant of Marketing Authorisation; as we'll become the single point of contact for the organization. This role will shadow the New Products Introduction Manager (Product Lead) to seek necessary knowledge of the new MA procedure and all the HA interactions that occurs during this procedure with an intent to identify specific negotiations, key commitments made and also identify potential post approval activities that might be necessary to either support a product launch or maintain continuity of supplies. This role will start working with NPI function, necessary stakeholders internal (such as Quality, Supply Chain, Technical, Medical or Commercial) and external (such as developer) to plan, strategize and execute all necessary post approval activities which will include but not limited to the following: Renewal Application and Annual Maintenance Variation Application Notification of Change in Marketing Status, sunset clause exemptions where applicable Notification of drug shortages Tracking and fulfillment of regulatory commitments made including any Specific Obligations for Conditionally /Exceptionally approved products. PIP Modifications, PIP compliance and associated label update Orphan Designation Maintenance (where applicable) Updation of NBO technical package (where applicable) This role will be assigned specific molecules, Primarily Innovative Medicines (but may as we'll extend other categories) and will become the LCM product lead for the assigned molecules globally, in all markets where there are registrations/Marketing Authorization available. This role will be expected to maintain and discuss/align Regulatory submission Plan, Regulatory Post Approval Strategy with cross functional teams. This role will be nominated to be involved being part of cross functional meetings such as Change Control Meeting, SNOP meeting etc for their assigned molecules. This role will be supported by Subject Matter Experts from the New Products Team (for Biosimilars and Specialty Generic Products) and Innovative Medicines team (for NCE and Biologics) for strategy formation and review. This role hence should be able to collaborate and work very closely with these functions throughout the life cycle of the products. This role will also contribute to the preparation of meeting packages for Scientific Advice, as and when needed and drive readiness preparation and participate in scientific advice as may be necessary to determine any post approval regulatory strategy. This role will support any market expansion activity by either driving or supporting a new product application of assigned molecules (already approved in EU, UK) to newer territories. This will be decided on a case-by-case basis. This role will be also responsible for maintaining Hand over document that would be used for further transition of responsibilities to LCM Established Products at a later stage for Innovative Medicines and Specialty Generic Products. While, ideally responsibilities of any approved products acquired through M&A will not sit with this role, howe'ver, depending on the nature of the products acquired, this role may be involved and become responsible for due diligence and integration. For example, any asset which is a Conditional Marketing Authorisation or has an Exceptional Circumstances status at the time of acquisition, would best sit with the LCM Strategic Growth team. Actively participate in continuous improvement initiatives, share ideas and thoughts, actively involve in implementation of such initiatives. Act as process owner for some regulatory procedures as and when delegated. Support line managers for readiness of any health authority inspection as and when delegated. Ensure timely completion of assigned Deviation and CAPAs. We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Graduate or post-graduate in any discipline of Science, preferably life science / Pharmacy. Knowledge, Skills & Experience: Significant experience of handling life cycle management of pharmaceuticals in EU/UK and other regulated markets (such as Canada, Australia and New Zealand) as an individual contributor. Good understanding of ICH Clinical and Safety guidelines should be able to interpret guidelines and apply them in practical situations independently we'll versed with EU/UK Regulatory procedures and processes. Good understanding and hands on experience of working on CTD. Experience interacting with EU/UK regulatory authorities Scientific advice meetings/ Pre-submission meetings. Experience of handling Innovative Medicines post approval changes such as PIP modifications and label expansions. Hands on experience of document management and change control management systems. Strong Project Management and Communication skills. Pleasant personality with collaborative approach, strategic mindset & Positive attitude. Demonstrate sense of drive and urgency through work. Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented). Excellent communication skills verbal and written; Ability to present to senior stakeholders confidently Ability to work under pressure and flexibility to adapt to evolving business situation. Inspired by our values of entrepreneurship, speed and integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Ability to have fun and thrive in a growing, unique, and inclusive work environment.