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SoluStaff is currently recruiting for a Regulatory Affairs Director to join the global team of a multinational specialty pharma company. In this role you will be responsible for submissions to, interactions with and communication with FDA, work collaboratively with cross functional teams defining regulatory strategies, projects and target outcomes to meet commercial objectives within regulatory guidelines. You will also need to have experience with the medical/legal/regulatory review process for promotional materials and labeling for US marketed products as the point person for regulatory in this process. This is a great opportunity to join a growing organization and support a new product submission and launch in the near term.

Requirements

• Establish regulatory strategies for clinical development programs, post marketing initiatives for commercial products working with multi-disciplinary teams.
• Align the regulatory strategy with project and business objectives, identify risks and mitigation scenarios for management consideration and approval.
• Oversee and manage regulatory information across clinical, non-clinical, CMC, labeling, and post approval change activities, ensuring consistency/ completeness/accuracy and adherence to regulations and applicable guidelines for all regulatory submissions.
• Lead preparation of regulatory FDA interactions and manage local submission tracking and regulatory data information within systems and document control activities.
• Prepare, maintain and/or coordinate IND and NDA/BLA submissions including amendments, supplements, variations, responses to FDA questions and requests, meeting requests, briefing packages, annual reports, etc. and manage the internal review and submission of these items.
• Participate in the Medical, Legal, Regulatory (MRL) review of promotional material and labeling for US marketed products and ensure timely submission to FDA as necessary, including new packaging artwork, and review revisions to packaging artwork for compliance with approved labeling.
• Review web sites and publications of relevant regulatory bodies with respect to policy changes, recent products approvals and recent public Advisory committee that could affect the companys registration status and apprise management accordingly.
• Actively collaborates with Global Regulatory Affairs team and cross functional colleagues in commercial operations, clinical development, quality, legal, compliance, etc. Monitor and report relevant changes to local requirements and competitor regulatory information to Global Regulatory Affairs, and local functions as impacted.
• Participate in the development of corporate Standard Operating Procedures.

Skill Set:

• Bachelors degree in life sciences (pharmacy, biology, chemistry, pharmacology), masters degree preferred.
• 10+ years experience in pharmaceutical full life-cycle regulatory activities experience in US & EU.
• Specific experience in Cardiovascular is desired
• Demonstrated ability to file INDs with the FDA. Experience of EU activities is desired.
• Experience must include proven direct interactions with the FDA and EU regulatory authorities developing dossiers including INDs, BLAs, briefing documents, etc.
• Excellent communication skills working in a multicultural, multinational, matrix environment.
• Excellent interpersonal skills are required.

Benefits

• Paid Time Off
• Medical, Dental, Vision and other Voluntary benefits
• Paid Parental Leave
• Tuition Assistance
• Discretionary Bonus Plan
• Competitive 401(k)