Job Title: Senior Regulatory Affairs Manager, Advertising and Promotion
Location: Remote 
Duration:03-06  Months

Top 3-5 Must-Have Non-Negotiable Skills Required

 

1.              At least 5 years of direct RA Ad Prom review experience for drug products

2.              Experience with Promomats/Veeva System

3.              Experience with 2253 submissions

4.              Strong collaboration and ability to work with cross-functional teams

Is a bachelor’s degree Required? Yes

How many years of recent experience does this person need to have? +5 years

Nice to Have Skills

• Medical or Scientific background
• The Senior Regulatory Affairs Manager, Advertising and Promotion is responsible for the review of Advertising and Promotional (Ad Prom) material for the Pharmaceutical Segment and accountable for all operational aspects of regulatory submissions providing planning and technical support for products both on market and new product launches.
• Review of Marketing materials to ensure compliance with current regulations and guidance's.
• Contribute to the development of marketing strategies including providing regulatory guidance and solutions to help reach business objectives.
• Plan and manage complex projects and prioritize workload.
• Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with and external standards.
• Maintain appropriate communication within the RA function, Marketing, and other functions primarily at the project team level.
• Communicate proactively and report to regulatory authorities.
• Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks.
• Contribute to the development and maintenance of processes and system for the review, approval, and submission of promotional materials.
• Set team, group, or service objectives to assure they align with the Regulatory strategy.
• Provide technical and strategic input for regulatory decisions
• May manage budget at country level.
• May provide direct supervision of individuals including mentoring, performance management and staffing decisions.

 

• Minimum of 7 years of experience in Regulatory Affairs Advertising & Promotion, including managing people or projects. Higher degree/PhD will be an advantage.
• Expert Regulatory knowledge in the Ad Prom space and other Regulatory functions.
• Strong ability to work with cross-functional teams
• Ability to oversee multiple projects in a matrix team environment.
• Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.
• Excellent oral and written communication and presentation skills.
• Ability to accomplish results through others.
• Ability to lead, coach, and motivate others.
• Bachelor’s degree or country equivalent in related scientific discipline.

  

About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $60.00/hr.