Regulatory Affairs Officer

Regulatory Affairs Associate Manager Location: Remote Duration: 7 months RESPONSIBILITES: - Validate product composition, ingredient lists, develop nutritionals and advise on/approve regulated claims for compliance under US laws and regulations - Participate in validation of marketing campaigns and review of associated materials - Approve packaging...

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...

**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...

**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...

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...

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...

Leading 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...

Senior Regulatory Affairs AssociateAround 4-8 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.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresContribute to preparation...

Senior Regulatory Affairs AssociateAround 4-8 years of relevant experience in handling of pre and post approval life cycle management of drug products (Biologics) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresContribute to preparation (including authoring where...

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:Relevant experience in regulatory package preparation, compilation and submission to Health Authorities in various markets with focus on EU countries.Working knowledge of EU regulatory procedures including adaptability to strict Health Authority and Sponsor timelines for completing submissionsKnowledge of EU country regulationsAble to...

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...

**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...

Responsibilities: - 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...

**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...

**Job Title: Chief Financial Officer (CFO)** **About Brewed Ventures**: Brewed Ventures Private Limited is a dynamic and innovative startup in the Tea industry, dedicated to revolutionising the way people experience their favourite daily brew. Committed to quality, sustainability, and creativity, we specialise in 100% Pure Farm to Cup tea products sourced...

ProductLife 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...

**Urgently looking for DRA** We are looking for DRA ( Drug Regulatory Affairs) in our Company. _Our Company is _ one of the Top Pharmaceutical Formulation Companies in India. Requirement Skills: - Knowledge of DRA - Problem Solving - Communication Skills Experience: 1-3 yr Salary : 35-45k **Job Types**: Full-time, Permanent Pay: ₹40,000.00 -...

**Description** **Medical Writer I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...

**Responsibilities**: - Conduct case law analysis to provide legal opinions and advice - Draft and review terms and conditions for contracts and agreements - Prepare cases for legal proceedings, including organizing and presenting evidence - Develop briefs and memoranda to support legal arguments and strategies - Conduct regulatory analysis to ensure...