Are you ready to take the next step in your regulatory affairs career with an innovative and fast-growing company? Rubicon Research Limited is offering exceptional career opportunities for passionate professionals in the regulatory affairs field. With an expanding team and a commitment to growth, Rubicon is the ideal place to shape your future while contributing to the success of groundbreaking products in the life sciences industry.
Company Introduction: Rubicon Research Limited
Rubicon Research Limited is a trailblazer in the life sciences sector, focused on creating high-quality, life-changing products that meet the ever-evolving demands of global healthcare markets. As a company, Rubicon is driven by innovation, dedication, and an unwavering commitment to improving lives. With its expanding Regulatory Affairs team, Rubicon is paving the way for professionals to grow alongside the company and become leaders in the industry.
Responsibilities in the Job
Rubicon Research is looking for dynamic professionals to fill key regulatory affairs positions in various specialized areas. As part of the Regulatory Affairs team, you will play a vital role in ensuring the compliance and success of products that make a global impact. Below are the primary responsibilities for the open roles:
- Labeling: Develop and manage labeling strategies for products, ensuring compliance with regulatory guidelines in target markets.
- Product Registration (Canada, Australia): Oversee the registration process for new products in Canada and Australia, ensuring that they meet local regulations and requirements.
- Annual Reports: Prepare and manage annual reports, ensuring all regulatory requirements are met for the continued approval and compliance of products.
- CMC, ANDA Submission: Handle Chemistry, Manufacturing, and Controls (CMC) submissions and Abbreviated New Drug Application (ANDA) filings, ensuring accurate documentation and timely submission.
Qualifications
Rubicon Research is looking for candidates with the following qualifications:
- A degree in Life Sciences, Pharmacy, or a related field.
- A strong understanding of regulatory affairs, with experience in one or more of the specialized areas mentioned above.
- Experience in global regulatory submissions, product registrations, and compliance.
- Knowledge of regulations specific to Canada, Australia, and other global markets is highly desirable.
Skills Required
To succeed in this role, candidates should possess the following skills:
- Excellent communication and documentation skills.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple projects simultaneously and work in a fast-paced environment.
- Attention to detail and a commitment to ensuring compliance with regulatory requirements.
- Ability to collaborate effectively with cross-functional teams.
How to Apply
Are you ready to join a company that values innovation, growth, and success? To apply for one of the exciting regulatory affairs roles at Rubicon Research Limited, please send your application to Madhura.patil@rubicon.co.in
