Regulatory Affairs Associate

**Job Title**:Pharmaceutical Regulatory Affairs Executive **(Intern)** **Location**: Pune, India **Duration**: 9 months (Advanced Certification) + 3 months (On the Job Internship) **Job Summary**: **Key Responsibilities**: 1. Attend classes on weekends (Saturdays and Sundays) 2. Complete coursework, assignments, and projects 3. Participate in...

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

Responsibilities In the context of a project for one of our top Pharma client, we’re looking for 2 talented Regulatory Affairs Officer to lead the following missions, and much more! Compile, or supervise the compilation of regulatory dossiers Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for...

**Career opportunity** **Consultant - Medical Device Regulatory and Clinical Affairs** **Project Associate - Remote, India **compliance with international regulatory requirements. We serve clients with hands-on support for compliance with applicable regulatory requirements of our clients’ target markets. Our services cover all steps of Medical Device and...

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

**Job Description**: - 4-6 yrs of experience in handling of pre and post approval life cycle management of Biologic products in various markets Regulated (EU/US/Canada) and Emerging Markets. - Experience of support the compiling, submission, and approval of country-specific submission files (MAA, LCM, and post-approval changes). Contribute to preparation...

We are looking for an Regulatory Publisher to develop new challenging projects which would include the following responsibilities: - Perform quality control procedures to ensure completion, correctness, navigability, and adherence to regulatory eCTD guidelines. - Perform document management tasks and post-submission activities including file transfer,...

**Required education**: Degree in relevant life science discipline **Required Experience**: 2-4 years relevant experience **Required Technical Skills**: - Lifecycle maintenance experience - Providing support during external and unannounced audits. - Responding to internal requests for technical and/or regulatory information. - Preparation and submission...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...

The Regulatory Project Assistant (RPA) is responsible for providing project administrative support to the the regulatory and scientific project team members (regulatory affairs, eTMF operations, medical writing, pharmacovigilance, and medical monitoring). The RPA properly manages personal timelines and workload distribution between short term and long term...

The Regulatory Project Assistant (RPA) is responsible for providing project administrative support to the regulatory project team members (regulatory affairs, eTMF operations). The RPA also supports activities within the regulatory website Clinical Trial Information System (CTIS) ensuring completeness and timely entry of information for EU submissions. The...

**Responsibilities and duties** **Requirements**: - Master’s Degree in Biological Science, applied biology or related field. - 3+ years’ practical experience with licenses and certification legal procedures. - Extensive background in data mining and analysis. - Able to understand various botanical and pharmacological common methods and specific...

**Responsibilities**: - To contribute to the production of client administrative documents and reports to be included in regulatory submissions - Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements - LCM, Systems Management and Administration - Document and track regulatory submissions and regulatory...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Summarized Purpose**: Serves as the lead over several countries/projects in providing innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through...

**Responsibilities**: - Preparation and submission of EU Marketing Authorisation Applications (Module 1,2,3) for Initial MAA and LCM (via DCP, MRP and NP) - Monitor and maintain up-to-date knowledge of national and European guidelines/legislation. - Ensuring compliance with all regulatory processes including MHRA and HPRA - Management of artwork...

We are looking for a Compliance Officer who will be responsible for developing and executing government affairs strategies, building relationships with key stakeholders, and representing our company's interests with regulatory bodies.You will play a pivotal role in influencing the regulatory environment for the Virtual Digital Assets sector in India and...

Job Overview - Maintain a repository of, and communicate on, international, regional and national legislations, recommendations and guidelines related to vigilances for all ranges of products such as medicinal products, medical devices, cosmetics, nutraceuticals. - Appropriately identify and address potential regulatory issue that may have an impact on the...

(India) Looking for experienced regulatory writers **As we are expanding our team, we are thrilled to announce that we are looking for experienced Indian regulatory writers to join our dynamic, collaborative team to engage with biopharmaceutical clients and prepare clinical and safety regulatory documents. This is a full-time, remote, salaried...

The primary duty of a Drug Safety Associate involves the ongoing monitoring and evaluation of adverse effects and safety concerns associated with drugs and medical products following market approval. As a Drug Safety Associate, your responsibilities will include monitoring, assessing, and reporting adverse events related to pharmaceutical products. You will...

Premier Research is looking for a Site Start Up Associate 1 to join the SSU Team in India. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are...