Associate Director, Promotional Regulatory Affairs
About The Position
The Associate Director, Promotional Regulatory Affairs provides regulatory guidance and risk assessment to cross-functional business teams developing initiatives intended to comply with US laws, rules, and regulations governing pharmaceutical advertising and promotion. The role works with a cross-functional review team, leads review and adjudication of promotional materials through the AstraZeneca Approval Process (AZAP), and represents AstraZeneca to regulatory authorities for assigned brands and projects as appropriate. It advises partners on their strategies and objectives and provides current interpretations and recommendations concerning FDA promotional regulations and related guidance. The position reviews promotional materials across HCP, consumer, and managed-market segments and print, broadcast, and electronic media. Materials may include sales and faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and other items routed through AZAP. The role also contributes to regulatory strategy, training, promotional guidance, FDA advisory-review requests, competitor product complaints, and monitoring regulatory developments. The position averages a minimum of three days per week in the office, with flexibility around individual circumstances.
Requirements
- At least 5 years of experience in drug or biologic regulatory affairs or a related pharmaceutical or biotechnology field.
- Working knowledge of FDA promotional regulations and the ability to apply that knowledge when reviewing diverse promotional materials and audiences.
- Working knowledge of the drug development process.
- Bachelor’s degree in pharmacy, pharmacology, life science, or a related field, or equivalent experience, is listed as a plus.
- Ability to manage a diverse workload and adjust quickly to changing business priorities.
- Ability to manage, coordinate, and execute projects independently with minimal supervision and in a timely manner.
- Effective verbal and written communication and influencing skills.
- Exemplary compliance ethics and high concern for standards.
- Strategic and analytical thinking and decision-making skills.
Nice To Haves
- Experience with electronic review and approval programs such as VEEVA PromoMats or other systems.
- Experience influencing others’ decision-making.
- Experience in therapeutic areas of AstraZeneca focus.
- Pharmaceutical or biotechnology regulatory, compliance, commercial, or medical affairs experience.
- Experience working in a team-based environment.
- Collaborative and solution-oriented mindset.
Responsibilities
- Provide regulatory guidance and risk assessments to business teams developing compliant pharmaceutical advertising and promotion initiatives.
- Lead review and adjudication of promotional materials through AZAP, covering HCP, consumer, and managed-market segments and print, broadcast, and electronic media.
- Review sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and other materials required to go through AZAP.
- Complete reviews within established timelines and accommodate expedited requests as priorities and workload allow.
- Assist in developing and implementing innovative regulatory strategies, including risk identification and contingency planning.
- Participate in asset prioritization and consultation meetings with Commercial Operations, MLR reviewers, and asset owners as requested.
- Advise business partners on implementing brand strategies.
- Develop PRA guidance and job aids for departmental and cross-functional use.
- Manage requests for FDA advisory review of materials and adjudicate incoming and outgoing competitor product complaints as appropriate.
- Help evaluate brand regulatory training needs and develop and deliver training with internal or external training initiatives or the PRA Skill Center.
- Monitor regulatory agency activities, new guidance, and emerging regulatory trends, and share relevant information with PRA and the business.
- Represent AstraZeneca to regulatory authorities for assigned brands and projects as appropriate.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
