Associate Director, Regulatory Affairs, CMC
Job Description
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 is responsible for assigned regulatory projects to ensure regulatory compliance for approved marketing applications (NDA/ MAA/ NDS etc.) and leading to successful preparation of clinical trial applications (IND/ CTA etc.). It also provides regulatory expertise to the Regulatory team.
Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
- Prepare regulatory filings for submission to US and international health agencies in the areas of new drug development, marketing applications and approved product support. This would include IND applications, annual reports, Investigator brochures, and meeting requests.
- Ensure conformance to commitments made with various health agencies (e.g., IND/ NDA/ MAA/ NDS commitments).
- Propose and/or assist in developing regulatory strategies; identify and implement appropriate submission strategies for assigned projects.
- Work with submission manager to 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.
- Participate in Regulatory interaction and presentations to Regulatory Health Authorities, customers and partners.
- Monitor and maintain awareness of regulatory environment assessing impact to business, interpret and disseminate information to affected departments.
- When needed, act as Regulatory Affairs CMC liaison with partner companies and contract manufacturers.
- Other duties as assigned.
Supervisory Responsibilities:
This person may have direct supervisory 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's degree in life science or related discipline required; advanced degree is preferred
- Minimum 8 years of progressively responsible experience in Regulatory Affairs or related CMC function in the U.S. pharmaceutical industry required
Knowledge, Skills, and Abilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Demonstrated strong understanding of the U.S., EU, and Canadian Regulatory requirements
- Proven ability to interpret and apply regulations to specific projects (FDA and ICH or other regulatory agency guidance requirements)
- Excellent written and verbal English communication skills
- Demonstrated organizational skills
- Proven negotiation skills.
- Proven ability to manage multiple projects, set priorities and meet deadlines
- Excellent skill level in MS Office including Word, Excel, and Outlook
- Ability to travel 15%
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse. Will need to lift and move boxes of paper and binders weighing up to 20 pounds.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Typical office setting, noise level is moderate with consistent printer, telephone ringing and conversation.
Benefits:
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave
The base pay range for this role in California is $132,000 per year to $170,000 per year. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.
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.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.
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