Director of Regulatory Affairs

Job Summary:
We are looking for an experienced Director of Regulatory Affairs to lead and manage the regulatory strategy for our pharmaceutical products. This role will ensure compliance with global regulatory standards, guide cross-functional teams, and oversee the preparation and submission of regulatory filings to authorities like the FDA and EMA.

Key Responsibilities:
Develop and execute global regulatory strategies for new and existing products.
Prepare, submit, and manage regulatory filings (e.g., INDs, NDAs, BLAs).
Lead and mentor a team of regulatory professionals.
Maintain relationships with regulatory agencies and ensure timely approvals.
Stay current on regulatory trends and advise senior management.
Collaborate with R&D, legal, and commercial teams to ensure compliance.
Qualifications:
Degree in Life Sciences (Pharmacy, Biology, Chemistry, etc.).
Minimum 10 years of regulatory affairs experience, with 5+ years in a leadership role.
Expertise in FDA, EMA, and global regulatory submission processes.
Strong communication, leadership, and problem-solving skills.
Benefits:
Competitive salary, health benefits, and retirement plans.
Professional development opportunities.