Sr. Manager, Regulatory Affairs - CMC

Regulatory Affairs San Diego, CA


Description

About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.  At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.

Summary:

This position provides regulatory expertise and leads regulatory projects for the Pacira Pharmaceuticals regulatory team.

  1. With minimum supervision, coordinate, write and review CMC sections for regulatory submission to US and international health agencies in the areas of new drug development, marketing applications, life-cycle management submissions, formal meeting briefing package, etc.
  2. Ensure conformance to commitments made with various health agencies (e.g., IND/NDA/MAA commitments).
  3. Assist in developing regulatory CMC strategies; identify and implement appropriate submission strategies for assigned projects. Provide input for product labeling, CMC changes and clinical projects.
  4. With minimum supervision, coordinate the submissions and ensure regulatory submissions are of high quality and submitted in a timely manner; review submissions for accuracy, completeness, and compliance with applicable regulatory requirements and internal procedures.
  5. With moderate supervision, participate in Regulatory interaction and presentations to Regulatory Health Authorities, customers and partners.
  6. Monitor and maintain awareness of regulatory environment assessing impact to business, interpret and disseminate information to affected departments.
  7. Other duties as assigned

 

Supervisory Responsibilities:

This person has no direct supervisor responsibilities.

 

Interaction:

The incumbent works closely with employees in all functional areas of the company to provide regulatory guidance and support.

 

Education and Experience:

  • Bachelor degree in life science from an accredited college or university.
  • Minimum 5 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry.

Knowledge, Skills, and Abilities:

  1. Demonstrated good knowledge of the U.S., EU and Canadian Regulatory requirements.
  2. Proven ability to interpret and apply regulations to specific projects (FDA and ICH or other regulatory agency guidance requirements).
  3. Excellent written and verbal English communication skills
  4. Demonstrated excellent organizational skills
  5. Proven negotiation skills.
  6. Proven ability to manage multiple projects, set priorities and meet deadlines.
  7. Excellent skill level in MS Office including Word, Excel and Outlook.

 

Work Environment:

Typical office setting, noise level is moderate with consistent printer, telephone ringing and conversation.

 

Travel Requirements:

5 - 10% of travel is expected.

 

 EEO Statement

Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.

At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.