10 Regulatory Strategy Jobs

Key Result Areas/outputs Activities . Ensure that all licensing for assigned products is complete in accordance with relevant norms Monitor status of product licenses Manage changes in product licenses and coordinate with other changes, planned and in progress Maintain complete documentation records Communicate changes to licenses status promptly Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy Ensure that local regulatory strategies are consistent with global product strategies and local priorities Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch Provide Leadership and direction within project teams Strive to ensure high levels of performance and achievements. Take decisions and accountability for actions. Build commitment within the team. Enhance positive attitudes and mindset. Demonstrate confidence and conviction. Challenge the status quo for continuous improvement. Help build an open and trusting atmosphere Assist in Issues. Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals/permissions Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products Communicate the impact of changes to key stakeholders. Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes Develop excellent relationships and partnerships with Regulatory Authorities Competitive Intelligence and Analysis Monitor the global pipelines of competing pharmaceutical companies Analyse gathered the information for its impact on AstraZeneca s proposed pipelines Provide a scenario with options and a risk-benefit analysis for AstraZeneca going forward

Key Result Areas/outputs Activities . Ensure that all licensing for assigned products is complete in accordance with relevant norms Monitor status of product licenses Manage changes in product licenses and coordinate with other changes, planned and in progress Maintain complete documentation records Communicate changes to licenses status promptly Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy Ensure that local regulatory strategies are consistent with global product strategies and local priorities Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch Provide Leadership and direction within project teams Strive to ensure high levels of performance and achievements. Take decisions and accountability for actions. Build commitment within the team. Enhance positive attitudes and mindset. Demonstrate confidence and conviction. Challenge the status quo for continuous improvement. Help build an open and trusting atmosphere Assist in Issues. Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals/permissions Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products Communicate the impact of changes to key stakeholders. Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes Develop excellent relationships and partnerships with Regulatory Authorities Competitive Intelligence and Analysis Monitor the global pipelines of competing pharmaceutical companies Analyse gathered the information for its impact on AstraZeneca s proposed pipelines Provide a scenario with options and a risk-benefit analysis for AstraZeneca going forward

Business: Piramal Pharma Solutions Department: CRA Travel: Moderate JOB OVERVIEW: Preparation of licenses application & filing them on governmental portals for approvals from Indian regulatory authorities required for manufacturing, marketing and export of products in domestic and overseas markets by PPL sites in India. KEY STAKEHOLDERS: INTERNAL: Manufacturing sites, R&D ,Program management, Supply Chain, Marketing, site regulatory KEY STAKEHOLDERS: EXTERNAL: Govt. authorities like State FDA, CDSCO, FSSAI, CBN, NCB, custom officials, Customers etc REPORTING STRUCTURE: (Reports To/ Direct Reports Y/N): Direct report to General Manager-RA ESSENTIAL QUALIFICATION: Graduate KEY ROLES/ RESPONSIBILITIES: KEY ROLES/RESPONSIBILITIES: Registration Application on various Government portals (CBN, Sugam, FSSAI & XLN India) for new user Ids creation. Follow up with State FDA Thane, CDSCO, FSSAI, NCB for grant of licenses Product Registration application in Form 41 on DCGI Sugam Portal. Written confirmation (WC) application on DCGI Sugam Portal for APIs. Preparation & Online Submission for Import License application in Form 10 Preparation & Online Submission for CBN permissions (Import Certificates & Quarterly return filling) Preparation & Online Submission of API, RLD Test License Applications (Form11 & Form CT 17). Preparation & Online Submission of CDSCO permission in Form CT-11, CT-14 & CT-15, Dual Use NOC & Export NOC Preparation & Online Submission of application on state FDA portals like Test Licenses (Form 29), wholesale license etc., Preparation & Online Submission of various CBN application (Import/ Export/Quota/Mfg. License). Quarterly return submission to CBN/NCB/State FDA Provide regulatory strategies and support all stakeholders w.r.t assessment of D&C Act Feedback on new guidance Review and assessment for selection of product for manufacturing at site as per the D&C act To create PR in SAP to process payment for various bills/Invoices received from consultants. KEY COMPETENCIES: written and spoken communications skills, cross functional collaboration, negotiation skills, meticulous planning and execution for timely receipt of approvals.

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. Key Activities Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions. Complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance. Reports needs for process changes to CMC systems and contributes to process improvements. Incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams. Reports issues to RA CMC product team management. May manage and develop junior staff. Key Responsibilities Include: Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development. Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally. Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation. Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff. Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments. Develop response strategy and respond to health authority questions. Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans. Liaise with local regulatory teams to align on filing strategy. Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system. Follow established department regulatory processes to ensure cross-product alignment. May manage staff. Knowledge and Skills Regulatory CMC-specific regulatory knowledge & experience Staff management and development Education & 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 OR High school diploma / GED and 12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

Regulatory Affairs Manager Devices What you will do Let's do this. Let's change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. Responsibilities: Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans Lead and/or support JAPAC health agency engagements Lead and/or support JAPAC filing activities and associated health agency inquiries Support device design controls activities and documentation reviews Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region Perform change control regulatory assessments as it relates to JAPAC Develop and support implementation and maintenance of internal regulatory processes Perform device determination decisions for regulated items to be developed and/or used in JAPAC region Support supplier engagement teams and due diligence activities in the JAPAC region Review regulatory sections in development, quality, and supply agreements that impact JAPAC region Support regulatory compliance initiatives in the JAPAC region What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree; or Master's degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or Bachelor's degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience Preferred Qualifications: Master's degree in regulatory affairs, engineering, or life sciences 6 or more years of experience in medical device regulatory affairs Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development Experience in drug delivery device or diagnostics device regulatory submission process 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

Manager - International Regulatory Lead Role Name Manager International Regulatory Lead (IRL) Department Name International Regulatory Team, Global Regulatory Affairs Role GCF5A ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to: optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience. Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills.

Role: Project Corporate Affairs Support - Deputy Manager Department: Corporate Affairs Location: Umrongso, Dima Hasao, Assam Qualification: MBA / MSW / LLB Job description: Support in executing the organizational growth & transformation goals, and protect & promote the reputation of the business in the region Minimize expenditure through effectively managing the departmental budget whilst consistently identifying and initiating cost saving initiatives Liaise with relevant departments in the region to ensure mitigation of regulatory risks by way of identifying, assessing and creating mitigation plans for the same Responsibility to manage PR and represent DCBL in front of various external stakeholders as per business requirements Focus on building sustainable relations at political, bureaucratic & other administrative levels Liaise with govt departments and local bodies as for matters pertaining to laws and adherence to legal requirements Co-ordinate with various departments to timely file claims and speedy processing of the incentive proposals Stay updated on the key happenings, movements, and other developments in the region and share relevant information's to Regional Corporate Affairs Head

Role Name: Clinical Transparency & Disclosure Sr. Associate Department Name: Global Regulatory Affairs & Strategy (GRAAS) Role GCF: 3 Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team. Required Skills: Experience understanding and interpreting data/information and its practical application Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through Ability to follow controlled processes Excellent spoken and written English Project management skills, including ability to prioritize work in order to meet required deadlines Problem solving ability. Basic Qualifications: Bachelors degree Minimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environment Familiarity with clinical research and clinical regulatory documents Knowledge of clinical trial disclosure regulations, guidelines, and best practices Preferred Qualifications: One year experience preparing regulatory documents for public disclosure.

What Youll do As a Regulatory Affairs professional within Organization, you will play a key role in channeling our scientific capabilities to make a positive impact on changing patients lives. In Regulatory Affairs, our teams influence the development of our innovative pipeline, define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs. In this way, our Regulatory Affairs teams are transforming exciting science into valued new medicines for patients around the world. Strategic thinking is key within our function. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity. Essential for the role In combination with your regulatory expertise, successful candidates will demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills. It is important that you embrace the concepts of novel regulatory tools and technology as well as a culture of sharing experiences with others so that the medicines that we develop will benefit from latest approaches in regulatory science. You are comfortable speaking the regulatory voice at all levels of the organization. Bachelors degree in a science related field. 3+ years of proven experience defining and implementing the regulatory strategy for a pharmaceutical organization. Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development Proven track record of regulatory drug development including product approval/launch. Experience in leading Major Health Authority interactions Ability to think strategically and critically and evaluate risks to regulatory activities. Ability to work strategically within a complex, business critical and high-profile development program.

Principal Responsibilities Ensure compliance with all company procedures, rules, and codes of practice, particularly regarding confidentiality and security of documents related to the companys business. Safeguard and prioritize the company's business interests at all times, maintaining and enhancing the companys reputation. Activities of the Regulatory Affairs & Pharmacovigilance Department: Health Authority Database Management: Responsible for maintaining and uploading data on health authority databases (SUGAM, FDA, etc.). Coordination for Product Dossier: Coordinate with global and local counterparts for product dossier preparation. Compile and submit applications for product registrations (local manufacturing and imports), including drugs, medical devices, food supplements, etc. Manage the CMC (Chemistry, Manufacturing, and Controls) section of the product dossiers. Regulatory Strategy & Compliance for Export Markets: Assist in developing and implementing regulatory strategies for the export of drug products to international markets. Ensure compliance with regulations in international markets, including Clinical Trials (CT) and Bioequivalence (BE) submissions to CDSCO. Preparation for SEC Meetings: Assist the Senior Manager/Director of Regulatory Affairs and Pharmacovigilance in preparing SEC slide decks. Organize mock SEC meetings with stakeholders and assist in other preparations for SEC meetings. Life-cycle Management: Responsible for life-cycle management activities, including labeling, CMC changes, license renewals, artwork management, and product testing in compliance with local and international regulations and company SOPs. Support artwork preparation and review. Inspection and Audit Preparation: Support the RA/PV team in planning and preparing for health authority inspections and internal audits. SOP Development and Compliance: Assist in the preparation of local SOPs. Handle quality complaints, product recalls, deviations, CAPA (Corrective and Preventive Actions), and changes, ensuring the databases are updated in accordance with local SOPs. Quality Management Systems (QMS) Compliance: Support the development and maintenance of QMS in compliance with Good Manufacturing Practices (GMP) and relevant standards. Pharmaceutical Responsibility and Compliance: Act as a deputy for the local pharmaceutical responsibility coordinator, ensuring proper documentation and implementation of pharmaceutical SOPs, quality complaint management, and reconciliation. Manage product complaints and coordinate investigations related to suspected falsified products. Assist with recall execution, coordination with involved personnel, and traceability of affected batches. Global Database Maintenance: Ensure timely data uploads and maintenance of global registration databases, complying with local and global guidance documents. General Responsibilities: Perform any other tasks relevant to the functioning of the Regulatory Affairs and Pharmacovigilance Department, as requested by management. Maintain a high level of discretion regarding confidential clinical studies and product information. Profile Requirements Minimum Requirements: Bachelors in Pharmacy or Masters in Science with 7-8 years of operational experience in handling regulatory and pharmacovigilance activities; MBBS/M. Pharm/Ph.D. (Pharmacology/ Pharmaceutics) graduates preferred. In-depth understanding of CMC, non-clinical, and clinical data aspects for regulatory submissions. Proficiency in MS Office (Word, PowerPoint, Excel, etc.). Ability to manage regulatory and PV activities in the absence of the Senior Manager. Indispensable Qualities: Professional and discreet approach to job responsibilities. Tactful in face-to-face meetings and interactions. Strong communication skills, both oral and written. Ability to work independently with minimal guidance. Flexible and capable of prioritizing tasks effectively. Energetic, enthusiastic, and committed to tasks. Ability to adhere to systems and standards while maintaining cordial relations. Competencies Required for the Job: Regulatory Knowledge: Ability to adhere to local (CDSCO) and international market regulations, and other legally enforceable requirements. Drug Development Knowledge: Understanding of the drug development process from discovery to market introduction. Responsiveness: Ability to mobilize resources and implement solutions quickly. Risk/Benefit Analysis: Ability to assess and quantify the risk and benefits associated with drug products. Scientific Knowledge: Ability to accumulate knowledge systematically and apply it to general principles. Learning Agility: Ability to rapidly learn and retain new information without compromising comprehension. Synthesis: Ability to bring together various elements of knowledge into a coherent, structured understanding. Adaptability: Ability to adjust behavior and actions according to different environments, issues, and stakeholders. Pedagogy: Ability to effectively teach and transmit knowledge using appropriate methods.