Regulatory Affairs Associate

3 days 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

    3 days 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...

  • Regulatory Affairs Associate-886

    1 day 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

    2 weeks 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...

  • Regulatory Affairs Officer 633

    2 weeks ago

    Remote, India ProductLife Group Full time

    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...

  • Junior 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...

  • Regulatory Affairs Associate

    1 week ago

    Remote, India Ayurveda Mantra Full time ₹ 3,00,000 - ₹ 3,60,000 per year

    Our leading herb territory is currently in need of a Regulatory Scientist to join our fast-growing team. The ideal candidate will be intricately involved in filing and getting Licences and other supporting documents for herb marketing and will regularly look for other supporting certificates and updates via theoretical approaches for the smooth establishment...

  • 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...

  • Pharmacovigilance Associate

    1 day 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...

  • 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...

  • Regulatory Project Assistant, India

    2 weeks ago

    Remote, India Innovaderm Research Full time

    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...