Biocare Group is a leading pharmaceutical company committed to improving global health through the development and commercialization of innovative healthcare products. With a strong focus on research and development, Biocare Group aims to provide safe and effective treatments for patients worldwide.
We are seeking an experienced and highly motivated Pharmaceutical Regulatory Affairs Specialist to join our team at Biocare Group. As the Manager of the Regulatory Affairs division, you will play a critical role in ensuring compliance with regulatory requirements and guiding the successful registration and approval of our pharmaceutical products.
- Oversee the Regulatory Affairs division, providing leadership and guidance to a team of regulatory professionals.
Develop and execute regulatory strategies for the registration and approval of pharmaceutical products in compliance with local and international regulations.- Collaborate with cross-functional teams, including R&D, Quality Assurance, Clinical Development, and Manufacturing, to ensure regulatory compliance throughout the product lifecycle.
Prepare and submit regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Applications (MAA).
- Interact with regulatory authorities and serve as the primary point of contact for regulatory agencies during inspections and audits.
Monitor and interpret changes in regulatory requirements, guidelines, and legislation, providing guidance to internal stakeholders to ensure compliance and mitigate risks.- Conduct regulatory assessments of new product developments, identifying potential regulatory hurdles and proposing strategies to overcome them.
Maintain up-to-date knowledge of industry trends, regulatory best practices, and competitive landscape to drive continuous improvement in regulatory affairs processes.
- Bachelor's degree in Pharmacy, Life Sciences, or a related field. Advanced degree is a plus.
Minimum of 5 years experience in pharmaceutical regulatory affairs, with a proven track record of successfully managing regulatory submissions and approvals.
- Strong knowledge of local and international regulatory requirements, including FDA regulations, ICH guidelines, and regional regulations (e.g., EMA, Health Canada, PMDA) will be an advantage.
Experience in leading and managing a team of regulatory professionals, fostering a collaborative and high-performing work environment.- Excellent communication and interpersonal skills, with the ability to effectively interact with internal teams, external stakeholders, and regulatory authorities.
Strong organizational and project management abilities, with a keen attention to detail and the ability to prioritize and manage multiple projects simultaneously.
- Ability to adapt to a fast-paced and dynamic work environment, demonstrating flexibility and resilience.
To apply for this position, please submit your resume and a cover letter outlining your relevant experience and qualifications to [Confidential Information]. We appreciate all applicants interest, but only those selected for an interview will be contacted.
- At Biocare Group, we foster a collaborative and inclusive work environment that encourages innovation, professional growth, and teamwork. We value diversity and believe in equal opportunities for all employees. Join us in our mission to make a positive impact on global healthcare.
Job Types: Full-time, Permanent
Pay: RM3,
- 00 - RM6,000.00 per month
Benefits: - Health insurance
Maternity leave- Opportunities for promotion
Professional development
Schedule:
Supplemental pay types:
* Yearly bonus
