2119 Regulatory Affairs Jobs - Page 5

Domain Expertise Areas & Role & Responsibility: Should be able to do as follows: Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in collaboration with the worlds Top Specialty Research Hospitals for multi-centred R & D. - KOL ...

Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in collaboration with the worlds Top Specialty Research Hospitals for multi-centred R & D. - KOL Management. - Clinical Business Operations, Business Operation. - Medical Educati...

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

Develop the regulatory compliance strategy / framework / compliance checklists for the various Centers of the company. Obtain all relevant licenses for Green field projects Verify all licenses of Brown field projects and support BD team in getting right licenses Read and interpret all the relevant acts and rules and prepare the procedures, forms, formats for obtaining regulatory clearances, licenses and permissions Keep track of all the changes in the various applicable laws, acts , rules and modify the existing processes, forms , procedures in alignment with the changes in the laws Work with Field / Geography teams for obtaining all the necessary regulatory permissions Develop relationships...

We are seeking an experienced Regulatory Affairs professional to support and manage the regulatory lifecycle of oral solid dosage (OSD) products across key global markets, including the EU, USA, and RoW.

Regulatory Affairs Monitor and analyze regulatory changes, tariff orders, grid codes, and policies issued by central (MoP, MNRE, CERC, CEA) and state authorities (KERC, KPTCL, CEIG, DISCOMs, SPCB). Assess the impact of regulatory updates on ongoing and upcoming projects and prepare briefs for management. Manage DPR/RFP documentation and compliance requirements. Represent the company in regulatory hearings, meetings, and policy consultations. Liaisoning & Approvals Conduct regular meetings/visits with Energy Dept., KREDL, KPTCL, SLDC, DISCOMs, CEIG , and other state agencies. Obtain and manage end-to-end permits and approvals including: Land Conversion / Acquisition Clearances Grid Connectivi...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Leads and manages a Regulatory Affairs team based in Mumbai in the following: T...

Lead government-sector business development initiatives. Secure government contracts, manage compliance, and build relationships with public sector entities. Prior experience in government tenders and regulatory frameworks is required. Key Responsibilities: Lead business development efforts to acquire new clients and partnerships. Develop and execute strategic plans to achieve sales targets and expand the customer base. Identify emerging markets and market shifts while being fully aware of new products and competition status. Build and maintain strong, long-lasting customer relationships. Partner with internal teams to ensure smooth onboarding and execution of client engagements. Forecast sa...

Lead government-sector business development initiatives. Secure government contracts, manage compliance, and build relationships with public sector entities. Prior experience in government tenders and regulatory frameworks is required. Mandatory Key Skillsgovernment tenders,regulatory frameworks,compliance management,business planning,Business Development*

Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in collaboration with the worlds Top Specialty Research Hospitals for multi-centred R & D. - KOL Management. - Clinical Business Operations, Business Operation. - Medical Educati...

Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in collaboration with the worlds Top Specialty Research Hospitals for multi-centred R & D. - KOL Management. - Clinical Business Operations, Business Operation. - Medical Education ...

Work Your Magic with us! Ready to explore, break barriers, and discover more We know youve got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich peoples lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us. Your Role To provide end-to-end support for Annual Reports and Renewals for all products, e.g. planning of required activities, attend kick-off/jour-fixe meetings, contribute to DSP and ensure timel...

Our Ideal Candidate: Our ideal candidate will typically be expected to demonstrate the following attributes: Good technical knowledge in Oracle Cloud Infrastructure Knowledge & working experience in ExaCS Understanding of Technical architecture landscape Should have a strong customer facing skills Ability to multitask, maintain composure in high-stress/high-visibility situations and change priority as needed to accommodate very dynamic business. Excellent team player, willing to learn new technologies Strong organization skills, detail oriented & communication skills. . University degree, with post graduate technical or management qualifications or other relevant experience. OCI Certified / ...

Founding Leadership Member/Director/Senior Consultant - Medical Operation/Medical Affairs Domain Expertise Areas & Role & Responsibility: Should be able to do as follows: Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in coll...

Be accountable for managing assigned product lines by developing and implementing business strategies aligned with overall Business Area goals and market needs. Drive sustainable revenue growth, improve profitability and linearity, and strengthen market presence while ensuring customer-centricity and operational excellence. Roles and Responsibilities: Collaborate with BA Head in defining business line strategy, ensuring revenue growth, linearity, and transformation. Conduct market research, competition review, and regulatory analysis for informed product line strategies and pricing decisions. Take full P&L responsibility for the business line; apply value selling, optimize Business line rela...

Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications

Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna. Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement. To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement. Responsible for prepare and review Drug Master File as per respective reulatory agency guidline. Responsible for ensuring that DMF submitting regulatory documentation, maintaning compliance and advising on regulatory strategies. To ensure that Drug Master File (DMF) meet to current respective regulatory agency guideline. Responsible for prepare Drug Master File (DMF) Defi...

Candidate with good English communication, presentation skills along with Regulatory affairs knowledge must know which Certificate and License's are required for the Medical device registration, willing to travel for Demo and Training Purposes 25%.

As a Senior Food Regulatory Professional at LabelBlind Solutions Pvt. Ltd., you will play a crucial role in leading regulatory intelligence and ensuring compliance with domestic and international food labelling regulations. Your responsibilities will include: - Leading regulatory intelligence on domestic and export food labelling regulations across multiple markets such as EU, US, UK, GCC, Canada, APAC, SE Asia, Latin America. - Monitoring, analyzing, and interpreting global regulatory updates to provide actionable insights for food businesses. - Demonstrating an in-depth understanding of national and international food laws regarding additives, ingredients, nutrition information, metrology ...

As a Safety PV Specialist at Syneos Health, you will play a crucial role in pharmacovigilance program delivery activities. Your responsibilities will include: - Assisting the CSH in collecting and reporting ADRs/AEs and other safety-relevant information. - Managing Periodic Safety Reports (PSR) in compliance with PSPV Quality Documents (QDs/SOPs) and local regulatory PV requirements. - Supporting PP/MAP approval and ensuring vendor PV training and regular refresher trainings. - Planning, tracking, and monitoring Master Planning Table and Affiliate Tracking Table (ATT) activity. - Participating in due diligence and integration processes for local product in-licensing or company acquisitions. ...

Company Overview: Lifenity Health Limited is a value-driven organization was evolved in 2012 with an aim to introduce wellness to infinite lives. We are one of the leading providers in the field of preventive and diagnostic health care solutions globally. We have the latest infrastructure, innovative technology, accreditation and pool of experts in health care, IT, and data analyst professionals to easily execute mass screening, diagnostics, and healthcare analytics which is acknowledged by eminent hospitals, healthcare professionals, and government bodies. Vision: To provide optimum health & wellness across the lifespan, of the population we serve. Mission: To provide quality diagnostic & h...

Job Description Job Title: Regulatory Affairs Excellence Specialistu00A0 Job Responsibilities Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organizational objectives. Works under general supervision and broad guidelines, consistently exercising independent judgment on matters of significance, ensuring adherence to company policies and regulatory requirements while maintaining high standards of performance and accountability. Demonstrates substantial understanding of regulator's role in the Quality System with good awareness of product lines, disease s...

The role is to assist in providing the regulatory administration activities of regional regulatory function. This position is responsible for organizing, revising and maintaining all regulatory documents within the regulatory department. The individual will assist in the registration of products by preparing and submitting documentation needed for registration in India. The individual will assist the team in any other responsibility as desired for regulatory work. Education: Postgraduate in Master of Business Administration (Pharmaceutical Management) Graduate in Pharmacy Experience: 4-5 years experience in FMCG/Pharma Industry in the field of pharmaceutical, general category products

Key Responsibilities Provide regulatory strategy and compliance guidance for SaMD and software-intensive medical devices . Interpret and apply global regulations (FDA, EU MDR, UKCA, Health Canada, etc.) and standards (ISO 13485, IEC 62304, ISO 14971, IEC 82304-1). Prepare and review regulatory submissions (510(k), CE Technical Files, UKCA documentation). Support risk management , cybersecurity compliance , and software lifecycle documentation . Collaborate with engineering teams to align design controls, verification/validation, and usability engineering with regulatory requirements. Stay updated on evolving regulations for AI/ML-based SaMD and digital health solutions. Required Skills & Exp...

** Urgent opening with FMCG Industry** Job Title: Associate Manager / Manager - Food Regulatory Affairs International Markets Location: Ahmedabad- ZCP, Gujarat, India Role: Responsible for ensuring compliance with all food safety and regulatory requirements for the organizations products. This role involves supporting the preparation, submission, and maintenance of regulatory documents and licenses, coordinating with internal and external stakeholders, and staying updated with evolving food regulations of respective international markets (UAE, Africa, Australia and Newzland, EU and USA). The incumbent will play a key role in safeguarding the companys regulatory standing and facilitating mark...