Associate Director, Promotional Regulatory Affairs
$150.1k - $225.15kAstraZeneca
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, or related field or equivalent experience a plus
- 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
- 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
If you are ready to lead with clarity, anticipate risk, and enable bold, compliant storytelling that advances patient impact, step forward and help us raise the bar for promotional excellence! The annual base pay for this position ranges from $150,098 to $225,147. 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. Date Posted
18-Aug-2026 Closing Date
16-Sep-2026
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.
- ...Director of Promotional Regulatory Affairs Are you ready to steer US promotional regulatory strategy in a way that accelerates responsible growth and earns patient and prescriber trust? This role translates science into clear, compliant communication across healthcare...SuggestedWork at officeFlexible hours3 days per week
- ...Precigen is seeking a highly motivated and experienced Associate Director/Senior Manager, Regulatory Affairs(level based on candidate experience). This role is... ....Develop effective professional relationships and promotes a positive company image with FDA and global...SuggestedWork at office
$100k - $140k
...have 8 products in the market that are making a real impact on patient outcomes. Responsibilities The Manager of Regulatory Affairs, Advertising and Promotion, is responsible for representing the Regulatory Affairs department at Promotional and Medical Review Committee...SuggestedWork at officeVisa sponsorship$100k - $140k
A leading biopharmaceutical company in Rockville is looking for a Regulatory Affairs Manager to oversee advertising and promotional materials. The ideal candidate should have a Pharm.D. or relevant experience in Regulatory Affairs. This role requires excellent communication...Suggested$138.75k - $231.25k
Associate Director Regulatory Affairs, OncologyAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent...SuggestedFull timeLocal area$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ....Innovation and Tools: Lead and promote the development of novel regulatory tools... ...maintenance and compliance activities associated with marketed brands, ensuring...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta... ...Innovation and Ways of Working: Lead, participate in, and promote major non-project functional or cross-functional...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$142.5k - $256.5k
...biotech industry.Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory Data... ...partner closely with Regulatory Affairs, Regulatory Operations, CMC, Labeling... ...are maintained while promoting data integrity and inspection readiness...Permanent employmentFull timeFor contractorsWork at officeWork from home$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care...Hourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week- ...Associate Director, Cell Therapy Trade Compliance Operations Introduction to role: At AstraZeneca Cell Therapy, we are building the... ...within Patient Supply Operations, Global Supply Chain, Quality, Regulatory, and Digital teams to ensure cross-border trade requirements...Hourly payTemporary workWork at officeFlexible hours3 days per week
$136.78k - $205.18k
...We are now recruiting an Associate Director, R&I Clinical Regulatory Writing (CReW). As part of a clinical delivery or submission team, the Associate Director provides strategic communications leadership to projects, establishes communication standards and best practice...Hourly payContract workTemporary work- AstraZeneca is seeking an Associate Director/Manager in Clinical Regulatory Writing in Gaithersburg, MD, with a hybrid work arrangement (3 days onsite). The role leads complex regulatory writing efforts across drug projects, ensuring regulatory and quality standards. You...
- ...ABOUT NAFSA: Association of International Educators With more than 10,000 members, NAFSA... ...and collaborative dialogues, and promotes research and knowledge creation to strengthen... ...POSITION SUMMARY The Associate Director, Conferences and Meetings works with the...Contract workFor contractorsWork experience placementWork at officeLocal areaWorldwideMonday to ThursdayFlexible hoursWeekend work
$208.06k - $262.15k
...prioritizes scientific integrity, regulatory excellence, and evidence-... ...practices and tools to promote engaged, collaborative, and results... ...the followingdirect reports:Director / Sr Manager, International regulatory... ...003504Job Category: Ext. Affairs, Regulatory, \&...Full timeWork experience placementWork at officeWorldwide$100.04k - $142.56k
...documentation (SOPs, forms, manuals), and associated audits to meet program objectives and... .... USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-... ...equitable management practices and tools to promote engaged, collaborative, and results-...Full timeWork at officeRemote workWorldwide- ...A commercial-stage biotechnology company focused on oncology and hematology is seeking a Director of Regulatory Affairs to support an expanding portfolio of programs spanning development through commercialization. This individual will play a key role in regulatory strategy...
- ...Zenith LifeScience is seeking a Regulatory Affairs Director to provide strategic and operational regulatory leadership across the development, commercialization and lifecycle management of a diverse product portfolio. The RAD will serve as global regulatory lead on select...
- ...EPM Scientific seeks a Director of Regulatory Affairs for a commercial-stage biotechnology company focused on oncology and hematology, supporting an expanding portfolio from development through commercialization. The role centers on leading NDA submissions, regulatory...
- ...Kolon TissueGene, Inc. is seeking an Associate Director, Bioinformatics to provide hands-on technical... ...with Clinical Operations, Medical Affairs, Regulatory, and external partners to align data... ...applicable regulatory requirements. Promote data integrity, documentation quality...
$160k - $215k
...communities.The opportunityAs the Associate Director, Rare Disease Product Marketing... ..., positioning, messaging, and promotional initiatives for HCP, payer,... ...Commercial, Medical, Market Access, Regulatory/Legal review, R&D, Corporate Affairs, and field teams to align brand...Full timeWork experience placementSummer work- Overview JOB SUMMARY: The Associate Service Delivery Manager position is responsible for delivering our IT managed services to a portfolio... ...client concerns and escalate issues appropriatelyIdentify and promote opportunities to improve our processes and service...Contract workFor contractorsWork at office
- ...VA, DC)Technical Summary:The Director, Marketing Compliance &... ...compliance, governance, and regulatory readiness programs, ensuring... ...visibility initiatives, including associated budget stewardship as... ...retention, and product/service promotion initiatives to meet business...Work experience placementFlexible hours
$137.7k - $210k
...development. MacroGenics' corporate culture promotes an atmosphere of innovation, open... ...customers for all Quality system related items associated with GMP, GCP, and GLP, with a strong... ...complaints.Supports and may host regulatory inspections and partner audits.Perform...Full timeCasual workLocal areaFlexible hours- ProKatchers LLC in Gaithersburg, MD invites an Associate Director, Clinical/Regulatory Writer to lead regulatory documentation in drug development. You will author CSPs, CSRs, IBs, Clinical Overviews, and Summary documents, interfacing with clinical, regulatory, and quality...
$131.6k - $205.7k
POSITION SUMMARY The Associate Director, Technical Writing will lead our technical writing team... ..., blogs, website content that promotes our products and services, ensuring alignment... ...accuracy, clarity, and compliance with regulatory requirements. Stakeholder...Temporary workWork at officeRemote workFlexible hours$170k - $200k
...and operational leadership to maintain a robust, risk-based compliance framework, promote a strong culture of integrity, and support business activities within a well-controlled regulatory environment, consistent with ISS STOXX group standards.The CCO reports to the...Local areaWorldwide- ...institutions, and other team members. Conducts regulatory research to maintain expertise and... ...internal policies and procedures. Promotes compliance initiatives and awareness... ...entities, organization officers, or board of directors during compliance reviews or...Work experience placementLocal area
$72k - $83k
...work ethic than your experience Love to promote from within Have dynamic and interesting... ...pride in all of our 5 star reviews The Associate Category Manager I is responsible for supporting... .... Participate in negotiations with Director of CM oversight; support profitable...Seasonal workShift work- The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important... ...submissions and approvals. The Clinical Regulatory Writing Associate Director is expected to: Independently manage clinical regulatory writing...
- Join AstraZeneca’s Oncology Business Unit (OBU) in a role where strategy meets scientific ambition. As an Associate Director, OBU Strategy, you will assist in the creation and implementation of strategies to deliver an exciting and innovative oncology pipeline. You will...Hourly payFull timeTemporary workFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director, Promotional Regulatory Affairs. Be the first to apply!
- associate director clinical operations Gaithersburg, MD
- associate scientific director Gaithersburg, MD
- associate manager Gaithersburg, MD
- associate director clinical data management Gaithersburg, MD
- associate clinical manager Gaithersburg, MD
- associate director clinical research Gaithersburg, MD
- remote associate product manager Gaithersburg, MD
- associate medical director Gaithersburg, MD
- associate director Gaithersburg, MD
- regulatory manager Gaithersburg, MD


