Assistant Regulatory Affairs Manager Sharp Hrd Services

7.0 - 12.0 years

4 - 8 Lacs

Paithan

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Role & responsibilities Asst. Manager (Regulatory Affairs) 1. The Candidate must be M.Sc or B.Pharma or M.Pharma with 7-12 years of experience out of which minimum 3-4 years in regulatory affairs in EU, US markets, WHO GMP certified pharmaceutical formulation company. He will be responsible for all regulatory functions- domestic as well as exports. He will coordinate with other departments on regular basis. He will provide documentation support required for regulatory submission independently, including preparation and submission of dossiers for product and plant registrations in different countries as per latest guidelines. Exposure to Regulatory Audits & QMS system. Knowledge of Drug & Cosmetic Act, DPCO & All other guidelines related to pharmaceutical industries Responsible for monitoring of critical processes for R&D in compliance of operations, Quality Management and regulatory affairs. Preparation or Review of SOPs, BMRs, MFRs, PVP, PVR, PDR, Chemical compatibility of drug product/Drug substance specifications, MOA and change control to ensure compliance. To ensure new products registration and license renewal compliance to local regulations, as well as GMP, GDP and ISO requirement. Review of formulation development protocols, and technology transfer dossier (TTD) Performing literature reviews and staying up-to-date with the latest advancements in pharmaceutical research to contribute to the development of new products. Ensure compliance with regulatory requirements, including FDA and global regulations, and maintain up-to-date knowledge of industry regulations and guidelines. Oversee R&D tasks, ensuring proper documentation of records and prepared of reports submitted to regulatory authorities. R&D document and their findings to support quality assurance, and regulatory affairs processes. Co- ordination with Quality assurance, Quality control, Production, Warehouse & Engineering department, ensure GMP and EHS related to R&D functions. Establish operational, analytical and documentation standards aligned with industry best practices. Preferred candidate profile

Posted 1 week ago

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Consultant - Presales - Healthcare & Lifesciences - ITeS/BPM - 4+ year Crescendo Global Leadership Hiring India

4 - 9 years

10 - 17 Lacs

Gurugram

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Location: Gurugram/Pune/Bengaluru We are looking for a dynamic domain expert in Life Sciences to drive transformational healthcare projects across US and European markets. If you are passionate about digital innovation and cross-functional leadership in the life sciences sector, this role is for you. Your Future Employer: is a leading global business process management company that co-creates innovative, tech-led solutions for Fortune 500 clients across multiple industriesincluding healthcare and life sciences. Responsibilities: Leading and delivering end-to-end life sciences transformation projects for clients across the US and Europe. Collaborating with cross-functional teams to identify and pitch digital solutions aligned with client goals. Supporting pre-sales and solution design by preparing RFIs, RFPs, and business cases. Creating thought leadership materials, market insights, and transformation blueprints. Driving client engagement and strategic project execution in a fast-paced, results-driven environment. Requirements: Graduation/Post Graduation with strong understanding of the US/UK/Europe life sciences market. Proven experience as an SME or Practice Leader in the life sciences domain. Proficiency in PowerPoint, Excel, and digital transformation tools. Strong analytical, communication, and project management skills. Ability to work independently and collaboratively with global stakeholders. What is in it for you? Opportunity to work with top-tier global clients and drive high-impact healthcare transformations. Be part of a vibrant, innovative work culture that values thought leadership and digital innovation. Continuous learning, career development, and growth in a future-focused industry domain. Reach Us: If you think this role is aligned with your career, kindly write to me at abhishek.pushkar@crescendogroup.in with your updated CV for a confidential discussion on the role. Disclaimer: Crescendo Global specializes in Senior to C-level niche recruitment. We are passionate about empowering job seekers and employers with an engaging, memorable job search and leadership hiring experience. Crescendo Global does not discriminate on the basis of race, religion, color, origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Note: We receive a lot of applications daily, so please assume your profile has not been shortlisted if you do not hear from us within one week. Your patience is appreciated. Scammers can misuse Crescendo Globals name for fake job offers. We never ask for money, purchases, or system upgrades. Verify all opportunities at www.crescendo-global.com and report fraud immediately. Stay alert! Profile Keywords: Crescendo Global, healthcare, life sciences, presales, solution design, RFP, RFQ, RFI, digital solutioning, project management, delivery management, digital transformation, business case creation, healthcare transformation, automation, RPA, global markets, US markets, European markets

Posted 2 months ago

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