Senior Manager, Regulatory Affairs

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.

• Lead regulatory projects focused on clinical and regulatory development; work closely with all functional areas of the company to provide guidance and support on regulatory matters.
• Provide support for 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. This includes annual reports, IND or other clinical-trial applications, meeting requests, and health-authority commitments.
• Serve as the Regulatory Affairs representative on assigned projects; project manage development teams and provide current regulatory information and guidance on a proactive basis.
• Support establishing strategies for regulatory document authoring; contribute strategically and scientifically at the project and/or study team level; manage vendors and external writers with regard to document quality; and develop regulatory writing timelines, processes, and working standards.
• Support or lead in preparation of high quality regulatory submissions in a timely manner, review submissions for accuracy, completeness, and compliance with applicable regulatory requirements and procedures.
• Support writing regulatory documents in compliance with company Standard Operating Procedures (SOPs) and applicable health authority guidance and regulations.
• Contribute to formation of key messages for health-authority submission and communications in consultation with functional area experts.
• Support creation and management of project plans for assigned projects; and collaborates with the cross-functional team members to ensure that projects are completed with the deliverables and timelines described in the projects' scope of work.
• Depending on experience and need, may be assigned other regulatory strategy or operational projects within the Regulatory Affairs department.

Supervisory Responsibilities:

This position may be responsible for assisting with the oversight of a variety of vendors and external writers.

Interaction:

This position may work closely with the VP, Regulatory Affairs along with others in the Regulatory Affairs, Clinical/Medical, Pharmacovigilance, R&D, Quality, Manufacturing and Executive staff, as well as external vendors and other writers.

Education and Experience:

• Bachelor's degree with a major in an analytical, data-oriented field of study from an accredited college or university is required; advanced degree is preferred.
• 5 years' experience in Regulatory Affairs, Regulatory Writing, Medical Writing or a related function with pharmaceutical or biological products required.

Qualifications:

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.

Knowledge, Skills, and Abilities:

• Knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes; accordingly, familiarity with regulatory, clinical, medical and scientific terminology is necessary
• Knowledge of clinical development required
• Knowledge of nonclinical, clinical pharmacology, biostatistics and CMC regulatory desirable
• Ability to develop and track a variety of diverse project budgets and identify key performance indicators, in a fast-paced, changing environment
• Proficiency using Microsoft Word, Excel and PowerPoint
• Excellent oral and written English communication skills
• Ability to present scientific and technical information in a concise and clear manner
• Experience with ex-US regulatory submissions is a plus
• Knowledge of project management and tools is preferred
• Experience managing cross-functional teams or projects in a pharmaceutical development setting
• Requires up to 30% travel

Physical Demands:

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 items weighing up to 20 pounds.

Work Environment:

The work setting is consistent of a typical pharmaceutical office environment with offices and cubicles.

• 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 is $120,000 per year to $160,000 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.