Senior Director, Regulatory Affairs Advertising, Promotion, & Labeling job in Parsippany

Job Type

Location

Salary

Date posted

Job title

Back to search results

Parsippany, New Jersey - NJ Pacira Pharmaceuticals, Inc.

Job Ref:	2442
Employer:	Pacira Pharmaceuticals, Inc.
Category:	General Marketing
Job Type:	Full Time
Salary and Benefits:	USD 203,000.00 per year
Location
State:	New Jersey - NJ
City:	Parsippany
Post Code:	07054
Map:	United States, New Jersey , Parsippany (Show on map)
Description
Overview At Pacira, innovation meets purpose. Pacira BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today, we're building on that legacy with next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is built on collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what's possible in pain management-and we can't do it without talented people like you. Why Join Us? At Pacira, every career is more than a job. Our mission drives us, and every day, we challenge ourselves to achieve the extraordinary. Integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team. Join the team in making better possible for patients everywhere. Summary This role directs, manages, evaluates and implements regulatory projects in support of company goals in the area of advertising, promotion and labeling. The position also provides guidance to cross-functional teams on regulatory strategy and tactics related to external communications and product labeling. Responsibilities 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. Advertising and Promotion Participate in and provide regulatory leadership and expertise to the Public Communications Review Committee (PCRC), which focuses on review of externally facing communications for commercial and investigational products. Develop and execute regulatory strategies and processes related to review and approval of externally facing communications or activities for commercial and investigational products by PCRC. Oversee all aspects of PCRC regulatory reviewers as appropriate to ensure successful review and approval of advertising and promotional materials. Serve as primary regulatory liaison to commercial, medical affairs, legal, etc. to ensure our practices are compliant with current regulatory standards. Develop and maintain current regulatory knowledge in the areas of advertising and promotion and advise management of significant developments. Ensure that the regulatory environment is continually monitored for new regulations, guidance, enforcement priorities and trends. Assure alignment and consistency of company policies across therapeutic areas and brands with respect to advertising and promotion review. Oversee the development and execution of regulatory strategies and processes as it relates to advertising and promotional materials. Plan and manage regulatory submissions related to advertising and promotional materials. Labeling Establish and oversee formal processes to provide regulatory support in the development, revision, review, and approval of labeling content for submission to Health Authorities (USPI, EU PI, and ROW labeling, as well as the internal Company Core Data Sheet). Develop and execute regulatory strategies and processes related to product labeling for commercial and investigational products. Lead organization in the strategic development of core data sheets and eventual product labeling. Coordinate with Clinical Regulatory to plan and manage regulatory submissions related to labeling and label changes. Develop and implement business processes to support product labeling activities. Participate on project and program teams and provide expertise on regulatory matters related to product labeling. Represent the company in its dealings with the FDA's OPDP and well as FDA Review Divisions pertaining to labeling. Lead or contribute to various cross-functional and cross-department continuous improvement initiatives Leadership Supervise and mentor direct reports to facilitate professional growth; identify training opportunities and provide mentoring to ensure individuals are appropriately developed in accordance with their roles and responsibilities. Identify resourcing needs and appropriate allocation activities to internal and external support. Drive continuous process improvements to enable an efficient and lean organization. Support budgeting and forecasting for function and Regulatory Affairs department. Manage vendors and contractors as applicable. Other responsibilities as needed. Supervisory Responsibilities: This position may have direct supervisor responsibilities. Interaction: Works closely with employees in all functional areas of the company to provide regulatory guidance and support. Qualifications Education and Experience: Bachelor 's degree in a life science with a minimum of 10 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry; or Master's degree in a life science with a minimum of 8 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry; or Doctoral (M.D., Ph.D., Pharm.D., etc.) degree with a minimum 6-year progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry Managerial experience desirable Knowledge, Skills, and Abilities: Excellent written and oral English communication skills Experience working within, and potentially managing, the Medical, Legal and Regulatory review process of promotional materials Experience and knowledge in the preparation of and post-approval management of prescription drug, biological, and/or medical device labeling Experience working with FDA's OPDP and submission of promotional materials Advanced knowledge of regulations and guidances related to the commercialization of pharmaceutical, biological, and/or medical device products in the US; experience in other global regions is preferred Outstanding written and verbal communication skills Excellent analytical and critical thinking skills Demonstrated negotiation and problem-solving skills Strong project management skills with keen attention to detail Expert knowledge of MS Word and ability to ensure adherence to internal templates and standards for regulatory submission documents Results-oriented with an enthusiastic attitude and strong interpersonal skills Proven attention to detail, while at the same time seeing the big strategic picture 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 accommodation 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 the computer screen, use of hands, fingers, and wrist to type on the keyboard, and manipulate the mouse. 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. The work setting is consistent of a typical pharmaceutical office environment with offices and cubicles. Benefits 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 Pay Transparency The base pay range for this role is $203,000 per year. to $265,000 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. Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered. EEO Statement 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.

ref: (2442) 1 day ago

Back to search results

Senior Director, Regulatory Affairs Advertising, Promotion, & Labeling job in Parsippany

Contact info

Parsippany, New Jersey - NJ Pacira Pharmaceuticals, Inc.

Location

Description

Related Jobs

Subscribe to our newsletter and stay ahead in the race for top marketing roles.