Regulatory Affairs Associate
At Pacira Pharmaceuticals, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Pacira Pharmaceuticals currently has an opening for a Regulatory Affairs Associate.
The Regulatory Affairs Associate works closely with employees in all functional areas of the company to provide critical support in the planning and preparation of regulatory submissions and the general execution of Regulatory Affairs research and product-support responsibilities. The incumbent will participate in interactions with vendors and corporate partners in the preparation, distribution, submission, and control of regulatory documents and information. The incumbent also supports the Chief Medical Officer as needed to ensure appropriate level of Company oversight of pharmacovigilance vendor.
- Assists with the preparation of regulatory filings for submission to US and international health agencies in the areas of new drug development, marketing applications and approved product support.
- Assists with or executes the electronic publication and submission of documents to the US FDA.
- Compiles materials required in submissions, license renewal and annual registrations.
- Monitors and improves tracking/control systems.
- Participates in Regulatory interaction with internal departments and external customers.
- Monitors and maintains awareness of the US and global regulatory environment, assessing impact to regulatory affairs practices and procedures.
- Prepares or assists in the preparation of routine regulatory reports including NDA and IND annual reports, PADERs, PSURs and DSURs. Participates in the development and review of departmental SOPs.
- In collaboration with external pharmacovigilance vendor, maintains on-site pharmacovigilance files and records and ensures their completeness and readiness for external (including health authority) audit or inspection.
- Assists the Chief Medical Officer as needed to ensure appropriate level of Company oversight of pharmacovigilance vendor.
The Qualified candidate will possess:
- Bachelor degree in the life sciences, chemistry, pharmacy, or other related course of study from accredited college or university; advanced degree is preferred.
- Minimum two years of relevant experience in pharmaceutical, biological product, or medical device Regulatory; will consider candidates with experience outside of regulatory affairs but with transferrable skillsets.
- Demonstrated understanding of US regulatory requirements; ability to interpret and apply the regulations to specific projects by referring to regulations as well as relevant FDA and ICH or other regulatory agency guidance requirements and other sources of information. Candidates without prior regulatory experience will be expected to quickly acquire the necessary regulatory knowledge base (regulations, regulatory guidance, and other sources of information) to be effective in this role.
- Excellent written and verbal English communication skills.
- Ability to manage multiple projects, set priorities and meet deadlines.
- Keen attention to detail.
- Strong ability in the use of writing and publishing computer applications; sufficient IT comfort to be able to learn new software specific to the regulatory affairs functions.
- Excellent skills in MS Office: Word, PowerPoint, Excel, Outlook.
Pacira Pharmaceuticals, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. EEO Employer: F/M/Disabled/Protected Veteran/Sexual Orientation/Gender Identity.