Regulatory Affairs Director for Global Compliance
4 days ago
We are seeking an experienced Regulatory Affairs Director to join our team in Singapore.
Job Description:- Key Responsibilities:
- Compliance and Submissions:
- Oversee the preparation, submission, and maintenance of regulatory filings and submissions to health authorities.
- Ensure compliance with local, regional, and international regulatory requirements.
- Monitor changes in regulatory policies and guidelines, and communicate their impact to relevant stakeholders.
- Regulatory Affairs Management:
- Lead and manage the regulatory affairs team, providing guidance, mentorship, and development opportunities.
- Coordinate and oversee regulatory activities across multiple projects and therapeutic areas.
- Represent the company in meetings and communications with regulatory agencies.
- Cross-Functional Collaboration:
- Work closely with R&D, Clinical, Quality, Manufacturing, and Commercial teams to ensure regulatory compliance throughout the product lifecycle.
- Provide regulatory expertise and support to cross-functional project teams.
- Facilitate effective communication and collaboration between regulatory affairs and other departments.
- Compliance and Submissions:
- Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field. Advanced degree (PhD, PharmD, or MD) is preferred.
- Experience:
- Minimum 10 years of experience in regulatory affairs within the pharmaceutical industry, with at least 5 years in a leadership role.
- Proven track record of successful regulatory submissions and approvals.
The estimated salary for this position is SGD $120,000 - $180,000 per annum, depending on experience.
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