Associate Director, Promotional Regulatory Affairs (BBU)

AstraZeneca plc; Gaithersburg (MD); Hybrid; USD 150.000 - 225.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement plan

Paid time off

Dental and vision coverage

Zusammenfassung

AstraZeneca is seeking an Associate Director Promotional Regulatory Affairs to lead regulatory reviews of promotional materials and guide cross-functional teams to ensure compliance with FDA rules through the AZAP process.

The role involves providing PRA guidance, monitoring regulatory developments, and coordinating with asset teams and Commercial Operations to align regulatory strategy with business goals.

Qualifikationen

• Bachelor's Degree in pharmacy, pharmacology, life science, or related field.
• 5 years’ experience in drug/biologic regulatory affairs or related pharmaceutical/biotech field.
• Working knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences.
• Working knowledge of the drug development process.
• Experience with electronic review and approval programs (VEEVA PromoMats or other) a plus.

Aufgaben

• Lead regulatory reviews of promotional materials for AZ products and audiences.
• Provide PRA guidance and training to cross-functional teams.
• Monitor regulatory guidance and emerging trends to inform strategy.
• Coordinate with asset owners and Commercial Operations to align regulatory planning.

Kenntnisse

Regulatory affairs

Pharmacy degree

FDA regulations

Drug development

Leadership

Ausbildung

Bachelor's in pharmacy

Tools

VEEVA PromoMats

Jobbeschreibung

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that are intended to comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products in the US. Lead review and adjudication of promotional materials as are required through the AstraZeneca Approval Process (AZAP). Represent AstraZeneca to regulatory authorities for assigned brand(s), and projects, as appropriate. Provide promotional regulatory advice and support to cross-functional partners in accordance with their respective strategies and objectives, as well as to provide current PRA interpretations and recommendations related to FDA promotional regulations and associated guidance.

Accountabilities

As the Associate Director Promotional Regulatory Affairs, you will ensure efficient and effective regulatory review and risk assessment of promotional material for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast and electronic), sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and any other materials required to be reviewed through AZAP. Conduct reviews within established timelines and meets expedited requests as priorities and workload allow. Assist in innovative regulatory strategy development and implementation, including risk identification and contingency planning.

You will participate with Commercial Operations, MLR reviewers, and asset owners in asset prioritization and consult meetings, as requested. Provide guidance to the business, as requested, to assist in implementation of Brand(s) strategy. Develop PRA guidance and job aids on relevant topics for use within the department and for use by cross-functional partners as appropriate.

You will manage requests for FDA advisory review of materials and adjudication of incoming/outgoing competitor product complaints, as appropriate. Help to evaluate Brand(s) regulatory training needs, develop and deliver training in partnership with the Internal and/or External Training Initiative or PRA Skill Center. Monitor regulatory agency activities, new guidance, and emerging trends in the regulatory environment, and shares such information within PRA and the business, as appropriate.

Essential Skills / Experience

• Bachelors Degree in pharmacy, pharmacology, life science, related science field

• 5 years’ experience in drug/biologic regulatory affairs or related pharmaceutical/biotech field

• Working knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences

• Working knowledge of the drug development process

• Experience with electronic review and approval programs (VEEVA PromoMats or other) a plus

Desirable Requirements

• Experience influencing decision-making of others

• Experience in therapeutic areas of AZ focus

• Pharmaceutical or biotech regulatory/compliance/commercial/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 analytic thinking and decision-making skills

• Ability to manage a diverse workload and quickly adjust to changing business priorities

• Ability to manage, coordinate, and execute on projects independently with minimum supervision and in a timely manner

The annual base pay for this position ranges from $150,202 - $225,303 USD Annual. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay(as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individualflexibility. Join us in our unique and ambitious world.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.