36 Regulatory Strategy Jobs - Page 2

The position of Manager is open in the Global Regulatory Affairs Specialty Pharma department. As a Regulatory CMC Product team member, you will provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded products being developed for the US and other advanced markets like EU & Canada. Your responsibilities will include ensuring lifecycle management by submitting annual reports and supplements in a timely manner to ensure product continuity. You will be accountable for the delivery of all regulatory milestones for higher complexity products, including assessing the probability of regulatory success and implementing risk mitigation measures. In thi...

Walk In Drive for API Regulatory Affairs Dept (RA) @ R&D Center Work/Interview Location :- MSN R&D Center, Pashamylaram, Isnapur, Telangana Interview Date:- 05-07-2025 @Saturday Interview Time :- 9AM TO 2PM Venue Details : MSN Laboratories Pvt. Ltd., MSN R&D center, Pashamylaram, Isnapur, Patancheru, Sangareddy Contact :- 9154811048 Regulatory Affairs Specialist to join our API Division. This role is critical to ensuring compliance with regulatory requirements for our active pharmaceutical ingredients (APIs). The ideal candidate should have 1-7 years of regulatory affairs experience in the pharmaceutical industry. Key Responsibilities: Regulatory Submissions: Prepare, submit, and manage regu...

Working knowledge of relevant global medical device regulations, requirements, and standards, such as ISO 13485, 21 CFR Parts 803, 806, and 820, ISO 14971, the European Medical Device Directive (93/42/EEC), and EU MDR (2017/745). Provide Quality and Regulatory Affairs input to the product development team and manage all QA & RA responsibilities throughout product development, design changes, and post-market surveillance processes. Establish and analyze key performance indicators to evaluate and continuously improve the Quality Management System (QMS). Possess broad experience and apply professional concepts and company objectives to resolve complex issues in creative and effective ways. Prov...

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 strateg...

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 strateg...

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/ RESPONSIB...

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. ...

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 d...

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) Man...

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 stak...

Develop business strategy, commercial plan & future product portfolio Make strategic & financial decisions that determine trajectory of the Unit, position Unit to be spun out & operate as independent entity Regulatory strategy of product portfolio Required Candidate profile Understand corporate finance and business management Experience in management relevant to Pharma manufacturing or micro-biology applications or lab instrumentation Experience in corporate management