job description
Join Brady Pharma Inc. as a Regulatory Affairs Associate and play a pivotal role in ensuring compliance with global regulatory standards. Based in the vibrant locale of Canggu, Bali, you will collaborate with cross-functional teams to prepare and submit technical documentation to regulatory agencies such as the FDA and other international bodies. This position offers a unique opportunity to contribute to the development and approval of life-saving pharmaceutical products while enjoying the dynamic work-life balance that Bali has to offer.
As a Regulatory Affairs Associate, you will be at the forefront of navigating complex regulatory landscapes, ensuring that our products meet the highest standards of safety, efficacy, and quality. Your work will directly impact our ability to bring innovative healthcare solutions to market, making a tangible difference in patients' lives worldwide.
Brady Pharma Inc. is committed to fostering a culture of excellence, innovation, and professional growth. We offer competitive compensation, comprehensive benefits, and the chance to work in one of the most inspiring locations in the world.
Responsibility
- Prepare and compile technical documentation required for regulatory submissions to agencies such as the FDA, EMA, and other international regulatory bodies.
- Coordinate with internal teams, including R&D, Quality Assurance, and Legal, to gather necessary data and ensure compliance with regulatory requirements.
- Review and analyze regulatory guidelines to ensure all submissions are accurate, complete, and submitted within designated timelines.
- Maintain and update regulatory databases and tracking systems to monitor the status of submissions and approvals.
- Liaise with regulatory agencies to address inquiries, provide additional information, and facilitate the approval process.
- Assist in the development and implementation of regulatory strategies for new and existing products.
- Conduct gap analyses to identify potential compliance issues and recommend corrective actions.
- Stay abreast of changes in regulatory policies and procedures to ensure ongoing compliance and best practices.
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. Advanced degrees are a plus.
- Minimum of 2 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong knowledge of regulatory guidelines and submission processes for FDA, EMA, and other global regulatory agencies.
- Excellent written and verbal communication skills, with the ability to prepare clear and concise regulatory documents.
- Detail-oriented with strong organizational skills and the ability to manage multiple projects simultaneously.
- Proficiency in regulatory database management and tracking systems.
- Ability to work collaboratively in a cross-functional team environment.
- Familiarity with ICH guidelines and GMP standards is highly desirable.