Regulatory-Affairs-Director, Regulatory-Affairs-Manager, Regulatory-Affairs-Specialist Jobs

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Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients.

Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.

Job Description:

Role Summary

The Director, Regulatory Affairs Advertising, Promotion & Labelling is responsible for leading all regulatory activities related to product labelling and the review of promotional and medical communications for Autolus products in the US/UK/EU, including providing strategic direction and tactical plans. The individual will lead and support development of collaborative processes, SOPs, and Work Instructions for cross-functional teams to ensure communications and activities are compliant and meet business objectives. Serving as an internal subject matter expert on global labelling, Advertising & Promotion landscape, this role requires a deep understanding of US, UK, & EU regulatory framework, exceptional strategic thinking, and the ability to navigate complex compliance requirements.

Key Responsibilities

• Global Regulatory Promotional and Medical Communication Strategy Development: Develop and implement a comprehensive regulatory strategy for advertising, promotion, and medical communication activities. Stay abreast of FDA and OPDP/APLB regulations, guidelines, and industry trends to ensure proactive compliance and identify opportunities for optimization and innovation.

• Lead interactions with the FDA OPDP/APLB pertinent to promotional and medical communications for assigned brand(s) in collaboration with the US Regulatory Lead. Provide regulatory

interpretations of applicable guidance and/or regulations or regulatory precedents.

• Support the development of Promotional and Medical Communications Material Review Process including required SOPs and Work Instructions for US (and globally based) on already established Veeva PromoMats system. Lead implementation of Veeva PromoMats process tools.

• Advise on the development of compliant product messages and materials across multiple functional areas. Accountable for timely regulatory review and approval of US promotional and medical communications of assigned brand(s) and pipeline products. Contribute to material review meetings to ensure compliance with established processes while enabling business needs to be met efficiently and effectively. Collaborate with Regulatory Operations, prepare and submit necessary regulatory documents (e.g. Form 2253) to OPDP/FDA as related to advertising and promotion.

• Collaborate closely with internal stakeholders, including Commercial, Marketing, Medical Affairs, Legal, Compliance, Regulatory Affairs, and others as applicable to align on regulatory requirements and strategies. Provide regulatory guidance and support to cross-functional teams to ensure compliance and achieve business objectives.

• Foster a culture of compliance and regulatory excellence within the organization. Foster an inclusive, collaborative, high-performing, and solution-oriented team environment to support business needs.

• Provide regulatory training as needed on FDA requirements, PhRMA DTC Guidelines and company materials review process.

• Lead global labelling strategy and development for assigned products, including TPLs, CCDS, USPI, SmPC, and related core labelling documents.

• Serve as the global labelling subject matter expert, providing strategic guidance on regulatory requirements, industry trends, competitor labelling, and product impact.

• Chair cross-functional labelling governance processes to drive timely review, approval, and implementation of global labelling updates.

• Ensure global, regional, and local labelling remains aligned, compliant, and supported by emerging clinical, safety, and manufacturing data.

• Partner across Regulatory Affairs, Supply Chain, Manufacturing and other functions to deliver submission-ready labelling content and support successful regulatory filings.

• Identify and mitigate labelling risks, resolve complex labelling issues, and escalate critical matters to Regulatory Affairs leadership as appropriate.

• Lead and contribute to the development of strategic responses to labelling-related Health Authority questions by partnering cross-functionally.

• Lead and support the creation, improvements, or periodic updates to departmental or cross-functional processes and SOPs as assigned.

• Occasional travel for business-critical meetings/events (domestic and international)

Demonstrated skills and competencies

E – Essential

P – Preferred

Experience

• Minimum of 15 years of experience in pharmaceutical industry with at least 10 years as a Regulatory Ad Promo professional and 6 years of strategic labeling experience.

• Solid understanding of the structure and function of the product labeling.

• Strong scientific background and ability to understand and interpret scientific documents and concept with the ability to translate them into labeling content or in the assessment of promotional claims.

• Knowledge of global standards and regulations related to CCDS and Product Labeling (USPI and EU SmPC experience required, other regional labels also preferred)

• Ability to guide cross-functional labeling team (including senior management) exhibiting a combination of active listening skills and the assurance to address labeling issues, develop plans of action, drive consensus, and oversee completion of labeling projects

• Self-starter with an ability to assimilate clinical and scientific information and present it concisely. Understanding of medical concepts and terminology

• Advanced understanding of FDA promotional regulations, industry trends, regulatory landscape, product, and therapeutic knowledge as well as evidentiary standards required to support product claims.

• Demonstrated business acumen and understanding of company objectives while executing regulatory strategies that deliver compliant and timely solutions that meet business objectives.

• Proven ability to identify issues and develop risk mitigation strategies and guidance.

• Efficiently plan, prioritize, and execute individual work and projects while balancing quality, risk, and benefits.

• Excellent communication skills (oral and written), project management and presentation skills

• Ability to present a compelling case for ideas, negotiate persuasively, and address disagreements constructively.

• Proficient in building agreement and acceptance through influence.

• A track-record of ability to handle critical issue situations effectively (E).

• Expert in Veeva PromoMats, and strong computer skills including MS Office: Word, Excel, PowerPoint, Outlook, Teams, and Adobe Acrobat

Qualifications

• BA/BS in a scientific discipline. Advanced or terminal scientific degree preferred.

Autolus Leadership Behaviours (incorporating Core Competencies)

Clarify direction and inspire; Using good judgement to set clear and compelling goals that show your team how their work contributes to our purpose and strategy

Deliver goals and plans; Creating joint plans with your team to deliver your goals, holding yourself and others accountable for delivering quality results

Work collaboratively; Cultivating a network of relationships across the organisation and building high performing teams based on mutual trust and respect

Optimise potential; Creating a healthy, engaged and empowered working environment that invests in people and their development.

Role Model our values; Acting as a role model ensuring everything you do is in line with our values of respect, integrity, focus and breakthrough

Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR)

Autolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations where appropriate.

Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR).

Autolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations throughout the recruitment process.

Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.

Originally posted on Himalayas

Summary

Key Responsibilities

Serves as the point of contact for Health Authorities.
Translates program regulatory strategy into clear interaction plans, submission plans, timelines, and cross-functional deliverables for ARTBIO’s clinical-stage radiopharmaceutical programs.
Leads the preparation, coordination, and delivery of regulatory submissions, including INDs, IND amendments, annual reports, meeting requests, CTAs, and other lifecycle submissions.
Schedules and coordinates meeting rehearsals prior to Health Authority interactions.
Finalizes meeting minutes with Health Authorities, responses to information requests, and follow-up actions.
Oversees publishing and submissions.
Partners with Clinical, Medical, CMC, Quality, Nonclinical, Clinical Operations, and other contributors to develop content, resolve data gaps, and maintain an aligned submission narrative.
Maintains clear records of correspondences, commitments, decisions, and submission history.
Establishes and maintains regulatory plans, workflows, submission calendars, trackers, and archives.

Qualifications & Education

Bachelor’s degree in a scientific, medical, pharmacy, or related discipline is required; an advanced degree is preferred.
12+ years of progressive regulatory affairs experience in the biotech or pharmaceutical industry, including demonstrating leadership in leading the deliverables for regulatory interactions supporting pre-IND to Phase 3 investigational-stage programs in oncology.
Strong knowledge of US FDA requirements and interaction processes
Proven track record coordinating US INDs, IND amendments, annual reports, health authority meeting packages, and responses to US FDA information requests.
Hands-on experience with electronic submission publishing, document management, submission standards, and external publishing vendors.
Experience and familiarity with leading submission of New Drug Applications, Marketing Authorization Applications, and radiopharmaceutical development are helpful.

Personal Attributes

Clear, concise communicator with strong scientific judgment and exceptional writing and editing skills.
Highly organized, proactive, and detail-oriented, with disciplined follow-through on commitments and timelines.
Comfortable working in a fast-paced biotech environment with evolving priorities and multiple stakeholders.
Collaborative leader who can align subject matter experts, challenge constructively, and drive decisions without losing momentum.
Commitment to quality, compliance, and patient safety.

What We Offer

A unique chance to contribute to first-in-class cancer therapies.
Exposure to both radiochemistry and CMC development in a dynamic biotech setting.
Hands-on training and professional development opportunities.
An international, collaborative, and supportive work culture.
Competitive compensation and benefits.

About Us

EEO Statement

Questions and Application Process

Originally posted on Himalayas