Regulatory Affairs Associate

1 week ago


Remote, India Parexel Full time

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 device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Travel: Yes
- Glassdoor Reviews and Company Rating

**Success Profile**:
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker

**Rewards**:

- **Global Impact**: We are one truly global team working together to propel each client´s journey ahead faster.
- **Balance**: We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Freedom**: The ability to innovate, ask “what if” and try new solutions without fear of failure.
- **Variety**: Opportunities to work on multiple accounts - never boring
- **Management**: Strong management with depth of experience working for global health authorities.
- 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 submissions
- Knowledge of EU country regulations
- Able to contribute as local SME for countries and collaborate with global team and other stake holders for increasingly more complex regulatory submissions for Clinical Trial Applications.
- Experience in handling health authority queries
- Good understanding and knowledge of ICH guidelines and Ethics Committee requirements forClinical Trial Applications in EU countries.
- Clear oral and written communication skills
- Acceptability towards varied cultural mindsets to collaborate efficiently with client counterparts and other internal stakeholders as well
- Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- Strong communications skills and ability to guide and mentor team members.
- Ability to work in different time zones
- Ability to work independently

LI-REMOTE


  • Regulatory Affairs

    1 week ago


    Remote, India Comtec IT Services Full time

    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...


  • Remote, India ProductLife Group Full time

    **Responsibilities**: - Contribute to regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions. - To contribute to the production of client administrative documents to be included in regulatory submissions -...


  • 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...


  • Remote, India ProductLife Group Full time

    Responsibilities - Contribute to regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions. - To contribute to the production of client administrative documents to be included in regulatory submissions - Compile...


  • Remote, India Medidee Full time

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


  • Remote, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878

    Regulatory Affairs ManagerAs a Regulatory Affairs Manager, you will be responsible for ensuring compliance with regulatory requirements in the pharmaceutical industry. Your expertise in document management, regulatory compliance, strategy and planning, project management, lifecycle management, coordination and communication, process optimization, and...


  • Remote, India beBeeCompliance Full time ₹ 5,00,000 - ₹ 8,00,000

    Job Description:">The Vigilance Specialist is responsible for managing product complaints, ensuring adherence to both internal procedures and external regulations.Determine regulatory reporting requirements and manage Health Authority Requests in compliance with EU MDR 2017/745 and other relevant global regulations.Facilitate and oversee complaint...


  • Remote, India Innovaderm Research Full time

    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...


  • Remote, India Satyam Group Full time

    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...

  • Vaf

    3 days ago


    Remote, India ProductLife Group Full time

    **Role Description**: **Role Responsibilities**: General: - Adherence to ProductLife Group’s values, policies, and quality management systems. - Provide high-quality work that contributes to client satisfaction and loyalty, leading to the optimization of repeat business and expansion of service provision across the Regulatory, Quality & Compliance service...