
Regulatory Affairs Officer 627
1 week ago
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 and the relevant data are generated to meet project objectives
Provide regulatory support to clients and associate companies
Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling
Review tasks for, support and mentor Regulatory Affairs Associates
Profile
UK and IE lifecycle maintenance experience
Providing support during external and unannounced audits.
Responding to internal requests for technical and/or regulatory information.
Preparation and submission of Technical/Site Transfer Applications
Assisting with the preparation of UK and IE Marketing Authorisation Applications
Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
Ensuring compliance with the regulations of the MHRA and HPRA
Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva (or comparable EDMS), LorenZ, Trackwise etc
A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
General regulatory administration duties and compliance requirements
Experience of promotional/non-promotional activities would be an advantage
Experience of operating within the post-Brexit regulatory landscape in UK and IE
Good IT skills/knowledge
Good organisational skills
Good communication skills
Pro-active attitude and able to work on own initiative as well as part of a team
Ability to prioritise different workloads/multi-task
Personal responsibility for ensuring a high standard of work
**Job Types**: Full-time, Temporary, Contract
-
Regulatory Affairs Associate
2 weeks ago
Remote, India Parexel Full timeAs 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...
-
Regulatory Affairs Associate
2 weeks ago
Remote, India Parexel Full timeAs 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...
-
Regulatory Affairs Associate
2 weeks ago
Remote, India Parexel Full time**Regulatory Affairs Associate** - Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. - Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory...
-
Regulatory Affairs Associate-886
2 weeks ago
Remote, India ProductLife Group Full time**Responsibilities**: - Contribute to regulatory activities such as pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions. - Document and track regulatory submissions and regulatory authority approval. - Provide on-going regulatory support to the Regulatory Affairs Specialist and to project teams to...
-
Regulatory Affairs Associate
1 week ago
Remote, India Endeavor Consulting Group Full timeLeading Global Cosmetics Consumer Products, Personal Care / Pharmaceutical corporation has an immediate need for an experienced Regulatory Affairs Associate. This is an excellent opportunity to join one of the world’s most respected and trusted companies. **Responsibilities**: - Review and respond to project team cross functional partners to provide...
-
Cta Officer 621
1 week ago
Remote, India ProductLife Group Full timeCTA Officer 621 In the context of a brand new project, we are looking for a consultant to join us asap on the following missions: **Responsibilities**: Responsible for overall planning and execution of regulatory and ethics submissions for assigned projects/countries (all regions especially Europe)/sites, which may include completion of submissions or...
-
Cmc Officer
2 weeks ago
Remote, India ProductLife Group Full time**MAIN RESPONSIBILITIES**: Provide technical support (internally and during meetings with prospects) and content for the preparation of proposals Prepare or review CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files). Define document writing strategies. Define positions for variation folders. Assess the compliance of...
-
Drug Safety Associate
2 weeks ago
Remote, India Satyam Group Full timeResponsibilities: - Receive and process adverse event reports from various sources, including healthcare professionals, consumers, and clinical trials. - Conduct initial assessment of reported adverse events to determine seriousness, expectedness, and causality. - Enter adverse event data into safety databases accurately and in a timely manner, ensuring...
-
Pharmacovigilance Associate
2 weeks ago
Remote, India Satyam Group Full time**Job Summary**: The Pharmacovigilance Associate plays a key role in monitoring and ensuring the safety of pharmaceutical products throughout their lifecycle. Working within a multidisciplinary team, the associate is responsible for the collection, assessment, and reporting of adverse events and safety information associated with medicinal products. This...
-
Medical Writing Officer
1 week ago
Remote, India ProductLife Group Full timeProductLife Group is looking for a Medical Writing Officer to join our dynamic team to contribute to the activities performed in the Hub: **Responsibilities**:Signal Management and Regulatory Intelligence**: Perform Signal Management Activities for clients Preparation of Signal Schedule Maintenance of Signal trackers Sharing of recommendation with...