Associate Director, Promotional Regulatory Affairs (BBU)
About The Position
The Associate Director, Promotional Regulatory Affairs works with cross-functional review teams to provide regulatory guidance and risk assessment for business initiatives intended to comply with US laws and regulations governing pharmaceutical advertising and promotion. The role leads the review and adjudication of promotional materials through the AstraZeneca Approval Process (AZAP), represents AstraZeneca to regulatory authorities for assigned brands and projects as appropriate, and advises cross-functional partners on promotional regulatory requirements and FDA guidance. The position reviews promotional materials across healthcare professional, consumer, and managed-market audiences and print, broadcast, and electronic media, along with sales and faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and other materials submitted through AZAP. The Associate Director supports promotional strategy and risk planning, participates in prioritization and consultation meetings, develops guidance and job aids, manages FDA advisory-review requests and product complaints, and helps assess and deliver regulatory training. The role also monitors regulatory agency activities, new guidance, and emerging regulatory trends and shares relevant information with PRA and the business. The position is based on an average expectation of at least three days per week in the office, with flexibility. The stated annual base pay range is $150,202–$225,303, with eligibility for incentives and benefits including retirement programs, paid time off, and health, dental, and vision coverage.
Requirements
- Bachelor's degree in pharmacy, pharmacology, a life science, or a related science field.
- 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.
Nice To Haves
- Experience with electronic review and approval programs such as VEEVA PromoMats or another system.
- Experience influencing others' decision-making.
- Experience in therapeutic areas that are a focus for AstraZeneca.
- Pharmaceutical or biotechnology regulatory, compliance, commercial, or medical affairs experience.
- Experience working in a team-based environment.
- Collaborative and solution-oriented mindset.
- Effective verbal and written communication and influencing skills.
- Exemplary compliance ethics and high concern for standards.
- Strategic and analytical thinking and decision-making skills.
- Ability to manage a diverse workload and quickly adjust to changing business priorities.
- Ability to independently manage, coordinate, and execute projects with minimal supervision and in a timely manner.
Responsibilities
- Provide regulatory guidance and risk assessment to cross-functional teams developing promotional initiatives intended to comply with applicable US laws, rules, and regulations.
- Lead review and adjudication of promotional materials through the AstraZeneca Approval Process (AZAP).
- Represent AstraZeneca to regulatory authorities for assigned brands and projects, as appropriate.
- Provide promotional regulatory advice and support to cross-functional partners in accordance with their strategies and objectives, including current interpretations and recommendations concerning FDA promotional regulations and guidance.
- Review promotional materials for healthcare professional, consumer, and managed-market audiences across print, broadcast, and electronic media, as well as sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and other materials submitted through AZAP.
- Conduct reviews within established timelines and handle expedited requests as priorities and workload allow.
- Assist with development and implementation of 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.
- Guide the business in implementing brand strategies, as requested.
- Develop PRA guidance and job aids for departmental and cross-functional use, as appropriate.
- 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 the Internal and/or External Training Initiative or PRA Skill Center.
- Monitor regulatory agency activities, new guidance, and emerging regulatory trends and share relevant information within PRA and the business.
Benefits
- Eligibility for short-term incentive bonuses.
- Eligibility for 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
Director
