Regulatory Affairs Manager

Job Description

We are seeking an experienced and dynamic Regulatory Affairs Manager to lead our regulatory team and oversee the compliance of our products with global regulatory requirements. The successful candidate will play a pivotal role in developing regulatory strategies, managing submissions, and maintaining productive relationships with regulatory agencies. This position is ideal for a leader with a strong background in regulatory affairs within the medical device, pharmaceutical, or biotech industries.

Key Responsibilities:

• Develop and implement regulatory strategies to ensure product approvals and compliance with global regulations.
• Lead the preparation, review, and submission of regulatory documentation, including INDs, NDAs, BLAs, and 510(k) filings.
• Serve as the primary point of contact for regulatory agencies, addressing queries and managing relationships.
• Stay updated on changes in regulatory policies and ensure timely communication and implementation within the organization.
• Provide regulatory guidance to cross-functional teams, including R&D, manufacturing, and quality assurance.
• Oversee the regulatory team, mentor junior staff, and manage departmental goals and timelines.
• Support audits and inspections by regulatory authorities and internal quality assurance teams.

Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
• 5+ years of experience in regulatory affairs, with at least 2 years in a managerial or leadership role.
• Comprehensive knowledge of FDA, EMA, and other global regulatory requirements and processes.
• Strong leadership and project management skills with the ability to lead cross-functional teams.
• Excellent analytical, organizational, and communication skills.
• Proven ability to manage multiple regulatory projects and deadlines effectively.

Benefits:

• Competitive salary and performance bonuses.
• Comprehensive health, dental, and vision insurance.
• Professional development opportunities, including training and certifications.
• A leadership role in a collaborative and innovative environment.

How to Apply:
Interested candidates are encouraged to submit their resume and cover letter detailing their regulatory experience and leadership capabilities.