Regulatory Affairs Pharmaceutical

1 week ago

Petaling Jaya, Malaysia BioCare Pharmaceutical Sdn Bhd Full time

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.

**Summary**

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.
- 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.

**Qualifications**:

- 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.

**How to Apply**:
**Company Culture**:

- 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: RM3,500.00 - RM6,000.00 per month

**Benefits**:

- Health insurance
- Maternity leave
- Opportunities for promotion
- Professional development

Schedule:

- Monday to Friday

Supplemental Pay:

- Performance bonus
- Yearly bonus

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