Regulatory Affairs Manager

2 months ago

Barrington, United States Eton Pharmaceuticals, Inc Full time

At Eton, we search the world over for meaningful therapies that we can bring to patients living with rare diseases.


Our location in Deer Park, IL currently has an opportunity for a Regulatory Affairs Manager. This is a hybrid position that will require 3 days a week onsite.


WHAT YOU’LL DO:


Primary Job Function:

The Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory submissions, approvals, and compliance activities for pharmaceutical products. This individual will work closely with cross-functional teams, including R&D, Quality Assurance, Marketing, and Legal, to ensure that all products comply with local, regional, and global regulatory standards. The Regulatory Affairs Manager will play a key role in aligning product development strategies with regulatory requirements, managing relationships with regulatory authorities, and leading regulatory documentation processes for product submissions.


Core Job Responsibilities:


Regulatory Strategy and Compliance

  • Develop and implement regulatory strategies to ensure timely approval of new products, line extensions, and lifecycle management activities.
  • Maintain a comprehensive understanding of current and emerging regulatory requirements, guidelines, and best practices across relevant regions (e.g., FDA, EMA, PMDA).
  • Ensure ongoing compliance with applicable regulatory standards for existing products.
  • Provide regulatory expertise and guidance to internal teams to support product development and marketing activities.


Regulatory Submissions and Documentation

  • Prepare, review, and submit regulatory applications, such as INDs, NDAs, ANDAs, and BLAs, ensuring that all documents meet regulatory authority requirements.
  • Coordinate the preparation of regulatory submission packages and respond to any questions or requests for additional information from regulatory bodies, including outside of the US
  • Develop, maintain, and ensure accuracy of regulatory documentation, including technical files, labeling, product information, and manufacturing data.
  • Work with Quality Assurance and Product Development to ensure that all regulatory documentation is complete, up-to-date, and readily accessible.


Cross-functional Collaboration and Communication

  • Facilitate communication between internal teams and external regulatory agencies, providing updates on regulatory developments and submission statuses.
  • Support product launch activities and provide strategic regulatory input to marketing and commercial teams.


Regulatory Intelligence and Policy Monitoring

  • Stay informed about changes in regulatory requirements, industry trends, and best practices by actively participating in industry associations and monitoring regulatory publications.
  • Advise management on potential impacts of regulatory changes and recommend risk mitigation strategies.


Risk Management and Issue Resolution

  • Identify regulatory risks associated with product development activities and develop strategies to mitigate these risks.
  • Lead or support investigations and resolutions of regulatory issues, ensuring alignment with company policies and regulatory requirements.
  • Engage in root-cause analysis and corrective actions for regulatory non-compliance or gaps, collaborating with Quality Assurance as needed.


Leadership and Team Development

  • Supervise and mentor junior regulatory affairs staff, providing guidance on regulatory strategies, documentation standards, and professional development.
  • Foster a culture of continuous learning, compliance, and operational excellence within the regulatory affairs team.


Position Accountability / Scope:

  • Attention to Detail: Ensures high accuracy in regulatory documents, submissions, and compliance activities.
  • Problem Solving: Anticipates and addresses potential regulatory hurdles, providing solutions to facilitate project success.
  • Leadership: Guides and inspires regulatory affairs team members, fostering a collaborative and compliant working environment.
  • Strategic Thinking: Develops and implements forward-thinking regulatory strategies that align with business objectives.
  • Ethics and Integrity: Adheres to strict ethical and regulatory guidelines, maintaining transparency in all regulatory affairs processes.


EDUCATION AND EXPERIENCE YOU’LL BRING


Educational Background:

  • Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field. A Master’s degree or higher is preferred.
  • Additional certification in Regulatory Affairs (e.g., RAC) is highly desirable.


Experience:

  • Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical industry, with at least 3 years in a managerial role.
  • Demonstrated experience with FDA, EMA, or other major regulatory authority submissions and approvals.
  • Proven track record of successful regulatory submissions and interactions with health authorities, including outside of the US

Technical Skills:

  • Strong knowledge of regulatory guidelines, including ICH, FDA, EMA, and relevant national standards.
  • Proficiency in regulatory submissions software and systems (e.g., eCTD).
  • Excellent project management skills, with the ability to manage multiple complex projects simultaneously.

Interpersonal Skills:

  • Strong written and verbal communication skills, with the ability to clearly articulate regulatory requirements and strategies to cross-functional teams.
  • Excellent organizational and analytical skills, with an eye for detail.
  • Ability to work effectively in a dynamic, fast-paced environment and adapt to changing priorities.


WHAT WE OFFER:

At Eton, you can have a good job that can grow into a great career. We offer:

Financial security through competitive compensation based on experience and qualifications

Health care coverage including medical, dental, and vision

Paid time off

401(k) retirement savings with a generous company match.

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