Senior Regulatory Affairs Manager

We are seeking an accomplished and results-driven Senior Manager of Regulatory Affairs for our client, one of the leading pharmaceutical companies in the San Francisco Bay Area. The post represents an excellent opportunity to take part in creative therapeutic product development and commercialization within a challenging and dynamic environment.

Overview

The Senior Manager Regulatory Affairs will lead the efforts in developing and executing regulatory strategies for our client's product portfolio. Therefore, we need an individual with expertise in global regulatory requirements, as well as excellent communication and interpersonal skills to facilitate effective working relationships within cross-functional teams.

Responsibilities

• Develop and execute global regulatory strategies for assigned products throughout their lifecycle.
• Regulatory guidance to cross-functional teams will be provided by this role on a wide range of issues.
• Anticipate and resolve potential regulatory challenges that are consistent with the business objectives of Regulatory Submissions and Compliance
• Provide leadership and direction for the preparation, review, and submission of high-quality regulatory documents including, but not limited to, INDs, NDAs, BLAs, and their international equivalents, in compliance with applicable regulations and guidelines.
• Respond to and manage health authority queries/information requests. Health Authority Interactions
• Guide interactions with regulatory agencies including FDA and EMA.
• Prepare for and participate in key regulatory meetings including pre-IND, end-of-phase 2, and pre-NDA/BLA meetings.
• Establish and maintain positive relationships with regulatory authorities.
• Team Management and Development Mentor junior Regulatory Affairs professionals, providing guidance to support their development.
• Emphasize continuous improvement and Regulatory excellence within the team.
• Interface effectively with internal stakeholders and external partners.

Qualifications

• Advanced degree in life sciences preferred (Ph.D., Pharm.D. or M.D.)
• Minimum of 8-10 years pharmaceutical industry experience in Regulatory Affairs, at least 3 years of which have been in a supervisory role
• Strong understanding of regulatory requirements of FDA, EMA and ICH throughout the product development process
• Proven track record of successful submissions and approvals with excellent project management, communication and leadership skills
• Experience in oncology, rare diseases, or other specialty therapeutic areas highly desirable

• Compensation and Benefits
• Competitive compensation package for the right candidate to include:
• Attractive base salary matching experience
• Annual bonus, performance-based
• Comprehensive health and wellness benefits
• 401(k) plan company match
• Generous paid time off and holidays
• Professional development

This is a great opportunity to make a real difference in the lives of patients while taking your career to the next level in a supportive and innovative environment.

If you have a passion for regulatory affairs and are seeking a leadership role at a dynamic pharmaceutical company, we encourage you to apply.

Qualified applicants should send their resume outlining their applicable experience and reasons for interest in the position. All inquiries will be received in strict confidence.