Regulatory Affairs Director - Oncology

Location: USA - Gaithersburg MD

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.

What you'll do:

• Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.

• Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labeling that is identified by the business, markets and patients.

• Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.

• Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST.

• Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success. Lead preparation of the regulatory strategy document and target product labeling.

• Own the negotiations with health authorities and initiate and deliver key regulatory documents.

• Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.

• Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

Minimum Qualifications:

• Bachelor’s degree in a science-related field such aslife sciences, pharmacy, biomedical sciences, or a related discipline, with a minimum of3 yearsexperience in regulatory affairs, regulatory strategy, or drug developmentwithin the pharmaceutical or biotechnology industry.

• strong knowledge of global regulatory affairs in oncology, across  bothearly and late-stage development, with experience supporting or shaping regulatory strategies for major submissions and health authority, primarily for FDA.

• Strong experience with filing of INDs, CTAs, NDAs, BLAs, lifecycle management activities, and regulatory pathways relevant to oncology products.

• demonstrated experience inregulatory drug development, including preparation formajor health authority interactions, development ofbriefing documents, contribution tolabeling strategy, and support forregulatory submission planning and execution.

• strong capability instrategic thinking, cross-functional leadership, regulatory risk assessment, problem solving, and stakeholder influence, along withexcellent oral and written communication skills. The ability to work effectively in aglobal matrix environment, lead through complexity, and drive alignment across multiple functions is essential.

Preferred Qualifications:

• Advanced degree preferred.

• Experience in Hematology is preferred.

• Prior experience with phase 3 design including end of phase 2 health authority interactions.

• Contribution to a regulatory approval including leading response team and labeling negotiations.

• Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.

• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.

• Ability to work strategically within a business critical and high-profile development program.

• Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.

Next Steps – Apply today!

Competitive salary and benefits package on offer:

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.

The annual base salary for this position ranges from $178,534 - 267,801. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit

Date Posted

Closing Date