Associate Director, Regulatory Affairs Advertising & Promotion

Pacira Pharmaceuticals, Inc.; Littleton (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

A leading pharmaceutical company in Littleton, NJ is seeking a Regulatory Affairs Manager. This role involves providing strategic guidance on promotional activities and reviewing promotional materials to ensure compliance with FDA regulations. The ideal candidate will have a strong background in regulatory affairs in the pharmaceutical industry and proven project management skills. Competitive salary and comprehensive benefits are offered.

Benefits

Medical, Prescription, Dental, Vision Coverage

401(k) with company match

Flexible Time Off

Paid Parental Leave

Life insurance

Qualifications

• 8+ years experience in Regulatory Affairs in the pharmaceutical industry.
• Managerial experience is desirable.
• Solid understanding of regulatory requirements.

Responsibilities

• Provide strategic guidance on promotional activities.
• Review and approve promotional materials.
• Serve as primary liaison with OPDP for assigned products.

Skills

Regulatory knowledge

Cross-functional collaboration

Project management

Analytical skills

Communication skills

Education

Bachelor's degree in a life science

Master’s degree in a life science

Doctoral degree in relevant field

Tools

MS Office

Adobe

Veeva PromoMats

Job description

Overview

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.

About Pacira

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

The primary purpose of this position is to provide strategic guidance and leadership relating to promotional activities. The role will be responsible for reviewing and approving all promotional and proactive medical materials for assigned marketed products, disease education materials, and products in development. The individual will also serve as the primary liaison for leading interactions with the OPDP for assigned products. The key aspect of this role is to enable the achievement of business objectives while ensuring compliance with applicable FDA regulations, guidance documents, and company policies. Additionally, the incumbent will help build the advertising and promotion team and capabilities.

Responsibilities

Essential Duties & Responsibilities:

• Serve as internal subject matter expert on promotional and medical review committees for assigned products to ensure compliance with regulatory requirements while meeting corporate strategic promotional objectives
• Collaborate with cross-functional teams, including commercial, medical, legal, and other expertise areas, for review and approval of promotional materials and materials used in scientific exchange for assigned products.
• Provide guidance and strategic support on proposed claims for products in development and develop Important Safety Information and Brief Summary documents as needed.
• Serve as primary liaison with OPDP for assigned products and manage interactions, including responses to regulatory inquiries or actions, preparing high-quality submissions for advisory comments, and, as needed, discussions.
• Educate colleagues on the regulatory environment and provide a risk assessment for proposed communication tactics and strategies.
• Continually develop, revise, and assess best practices, working instructions, and SOPs for promotional activities to establish standards and consistency across company brands. Monitor for OPDP enforcement actions, new or revised legislation, guidance documents, and industry standards related to prescription drug promotion, and communicate to the organization, providing training as needed.
• Work closely with Regulatory Operations in making timely 2253 submissions to OPDP.
• Work closely with regulatory strategy development colleagues regarding proposed product labeling changes to assess and determine the impact on promotional materials.
• Provide advice regarding clinical trial design elements and labeling needed to support target product profiles and desired commercial claims.
• Other duties as assigned.

Supervisory Responsibilities:
This position may have supervisory responsibilities.

Interaction:
The incumbent 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 8 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 6 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 4 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry
• Managerial experience desirable

Knowledge, Skills, and Abilities:

• Solid understanding of regulatory requirements, particularly in the areas of advertising and promotional activities
• Depth of knowledge and expertise to navigate the complexities of regulatory affairs for promotional materials
• Ability to develop and implement regulatory strategies aligned with business goals and market dynamics
• Experience with cross-functional teams and negotiating, collaborating, and managing risks
• Effective project management skills to oversee the development, review, and approval of promotional materials, ensuring timely submissions and compliance
• Ability to conduct risk assessments for promotional campaigns and develop strategies to mitigate risks
• Skilled in representing the company’s regulatory interests in interactions with OPDP
• Demonstrated ability to manage multiple assignments, appropriately identify regulatory issues, and communicate as needed to management
• Detail-oriented with the ability to promptly assess materials for accuracy as well as consistency
• Excellent organizational skills with the ability to influence, without authority, others positively and effectively

Competencies:

• Excellent communication skills, both written and verbal, to convey complex regulatory concepts clearly to various stakeholders and to represent the organization in regulatory interactions.
• Strong collaboration skills to work effectively with cross-functional teams, including marketing, legal, medical affairs, and regulatory teams, ensuring regulatory considerations are integrated into promotional strategies.
• Ability to provide training on regulatory requirements for promotional activities and support the professional development of regulatory and cross-functional teams.
• Strong analytical and problem-solving skills, along with the ability to make informed decisions in a dynamic regulatory environment,
• Proactively remains informed about regulatory trends, changes, and emerging requirements, and applies this intelligence to regulatory strategies.
• Flexibility and adaptability to navigate evolving regulatory landscapes and respond to changes in regulatory requirements
• Demonstrated proficiency with MS Office programs, Adobe, and Veeva PromoMats

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 computer screen, use of hands, fingers and wrist to type on keyboard and manipulate 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

• 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 $140,000 per year to $190,000 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

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.