AbbVie
Global biopharmaceutical company developing medicines
Senior Manager - Regulatory Affairs
Three days on-site per week, Tuesday through Thursday.
About the job
- The candidate must be an experienced regulatory professional in the pharmaceutical industry with a clear understanding of the United Kingdom regulatory and submissions process.
- The candidate must have experience as a line manager with highly developed people skills.
- The candidate must be able to multitask, prioritize, and manage multiple projects and deadlines.
- The candidate must be able to work effectively and collaboratively across cultures and cross-functionally.
- The candidate must have strong diplomacy, influencing, and presentation skills.
- The candidate must have a consultative and collaborative interpersonal style.
- The candidate must have excellent written, verbal, and interpersonal skills in English.
- The candidate must be able to identify compliance risks and escalate them when necessary.
- The candidate must have a Life Sciences degree in a relevant subject area.
- The candidate must be computer literate.
- Act as the primary Regulatory contact for the identified therapeutic area of responsibility.
- Provide line management responsibility for a small team within UK Regulatory Affairs, including recruitment, goal setting, performance appraisal, and talent development.
- Oversee all regulatory activities within the therapeutic area of responsibility, including maintaining licensing and contributing to Brand Team priorities.
- Guide the team in developing robust regulatory strategies and timely submissions to the Medicines and Healthcare products Regulatory Agency, ensuring approvals, implementations, and product launches.
- Develop and maintain relationships with Area and Affiliate members of GRS Europe and cross-functional partners to share knowledge, increase regulatory awareness, and build networks.
- Engage externally with the Health Authority on regulatory submissions and with pharmaceutical industry trade associations as required.
- Support the business in planning and executing product launches, acquisitions, and divestitures as required.
- Provide guidance and recommendations on United Kingdom regulatory strategies and tactical plans throughout the product lifecycle, including clinical trial submissions, variations, paediatric investigation plans, new marketing authorization applications, and liaison with local regulatory authorities.
- Review regulatory submissions for the UK Regulatory Affairs team in assigned areas of responsibility, correct them where necessary, and provide feedback.
- Interact with regulatory policymakers and professional associations, including the Association of the British Pharmaceutical Industry, to gather knowledge about trends, future changes, and the current regulatory landscape in accordance with national and European Union legislation and relevant association codes, and advocate for AbbVie's interests.
- Ensure compliance with AbbVie's policies and procedures to meet statutory, quality, and business requirements, acting as the primary regulatory contact for audits and inspections in the United Kingdom as appropriate and supporting oversight of divisional policies and procedures.
- Ensure compliance with United Kingdom legislation for medicines, medical devices, clinical trials, and paediatric investigation plans, and maintain awareness of the Association of the British Pharmaceutical Industry code.
- Act as the regulatory liaison with Area and local United Kingdom cross-functional teams to ensure United Kingdom strategies align with global strategies while maintaining compliance with local regulations.
- Understand and articulate the regulatory perspective across the business, translating key regulatory decisions into their impact on products in the United Kingdom.
- Act as lead Regulatory representative on Affiliate committees and initiatives as required.
- Act as deputy to the United Kingdom Regulatory Affairs Managers and/or Director as required.
- Provide leadership and direction to the United Kingdom Regulatory Therapeutic team to support implementation of regulatory product strategies, relationships with the Medicines and Healthcare products Regulatory Agency and local pharmaceutical company trade associations, process improvements, internal compliance, team consistency, individual professional development, improved capability, and upskilling.
- Support recruitment activities as required and retain high-caliber regulatory affairs professionals.
About the company
AbbVie is a global biopharmaceutical company that develops and sells medicines to treat serious health conditions. Its portfolio spans immunology, oncology, virology, neuroscience, and aesthetics, with products designed to modulate the immune system, target disease pathways, or support medical aesthetics. AbbVie compounds its products through a heavy emphasis on research and development, investing billions to build a steady pipeline of new therapies. Its medicines are brought to market by selling to healthcare providers, hospitals, and clinics, and in some cases directly to patients via prescriptions. The company differentiates itself through a wide, globally distributed product line, substantial R&D investment, and a commitment to sustainability and patient care, including science-based targets. AbbVie’s goal is to improve patient outcomes by delivering effective treatments for unmet medical needs while pursuing long-term, responsible growth across healthcare markets.
Company Size
10,001+
Company Stage
IPO
Headquarters
North Chicago, Illinois
Founded
1888
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Simplify's Take
What believers are saying
- RINVOQ gained European approval for juvenile idiopathic arthritis on September 22, 2026.
- July 2026 European approval expanded RINVOQ in severe alopecia areata.
- Etentamig delivered 74% response rates in September 2026 myeloma data.
What critics are saying
- Humira sales fell 36.1% in July 2026, exposing lingering erosion.
- Apogee dilutes 2026 EPS by $0.14, then $0.46 in 2027.
- Rinvoq and Skyrizi face 2033 patent pressure despite current settlements.
What makes AbbVie unique
- Skyrizi and Rinvoq anchor AbbVie’s post-Humira immunology franchise in 2026.
- Apogee acquisition adds zumilokibart and asthma biology after September 3, 2026.
- Iambic collaboration broadens AI discovery across immunology, neuroscience, and oncology.
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Benefits
Remote Work Options
Flexible Work Hours
Professional Development Budget
Growth & Insights and Company News
6 month growth
↑ 5%1 year growth
↑ 5%2 year growth
↑ 5%ADARx Pharmaceuticals has priced its initial public offering of 21.875 million shares between $15.00 and $17.00 per share, according to an SEC filing. The San Diego-based late-clinical stage biotechnology company has applied to list on Nasdaq under the ticker "ADRX". AbbVie has agreed to purchase shares in a concurrent private placement that would give it approximately 4.9% ownership of ADARx's outstanding stock. Underwriters have a 30-day option to purchase up to 3.28 million additional shares. The company estimates net proceeds of approximately $397.1 million, or $445.9 million if underwriters exercise their option in full, assuming a $16.00 share price. Proceeds will fund clinical trial development and general corporate purposes.
AbbVie and Iambic Therapeutics have entered into a multi-year collaboration to accelerate AI-driven drug discovery in immunology, neuroscience, and oncology. The partnership will combine Iambic's molecular superintelligence platform with AbbVie's therapeutic expertise to develop small molecule therapies with first-in-class and best-in-class potential. The collaboration will utilise Enchant v3, Iambic's next-generation multimodal transformer model trained on over 6,000 molecular properties. This technology is designed to optimise candidate properties simultaneously, reducing drug discovery timelines whilst improving success rates. Under the agreement, Iambic will receive an upfront payment and is eligible for success-based milestone payments and tiered royalties on net sales from products generated through the collaboration. The partnership aims to accelerate the discovery process and deliver breakthrough medicines to patients more quickly.
Acquisition adds a potential first-in-class in vivo targeted lipid nanoparticle (tLNP) anti-CD19 CAR-T therapy candidate for B cell-mediated autoimmune diseases as well as a proprietary tLNP...
Acquisition deepens AbbVie's robust immunology pipeline with diverse assets targeting dermatologic, respiratory and other inflammatory and immunological diseases Apogee's lead asset, zumilokibart,...
September 18, 2026 AbbVie highlights new real-world data supporting the effectiveness of VRAYLAR(R)(cariprazine) at Psych Congress 2026. * New data from prospective real-world studies of VRAYLAR showed meaningful improvements in depressive symptoms, functioning and quality of life among adults living with major depressive disorder (MDD) and bipolar I (BP-I) depression * These findings provide additional evidence that the benefits observed with VRAYLAR in clinical trials can also be achieved in routine practice, where patients often have more complex treatment needs NORTH CHICAGO, Ill., Sept. 18, 2026 /PRNewswire/ - AbbVie (NYSE: ABBV) today presented new VRAYLAR(R)(cariprazine) data at Psych Congress 2026 in New Orleans, including results from two prospective real-world observational studies in major depressive disorder (MDD) and bipolar I disorder (BP-I). The findings reinforce that the efficacy established in clinical trials translates to effectiveness in the broader, more clinically complex patient populations healthcare providers treat every day. "Because mood disorders are highly heterogeneous, it is critical to evaluate treatments in real-world settings where care is delivered every day," said Mudra Kapoor, M.D., vice president, global medical affairs, AbbVie. "These prospective studies provide additional evidence that VRAYLAR can help patients achieve meaningful improvements in depressive symptoms, functioning and other patient-centered outcomes in routine clinical practice." In the real-world BP-I depression study, CReW BP-I, patients treated with VRAYLAR experienced significant improvements in depressive symptoms as well as outcomes that affect daily life, including functioning and quality of life, after 12 weeks of treatment in routine clinical practice; the most common adverse events were nausea and dizziness. In ProACt, a real-world study of adjunctive VRAYLAR in MDD, interim findings showed improvements not only in depressive symptoms, but also in outcomes that affect day-to-day life and matter most to patients, including functioning, motivation, energy and anhedonia. In addition to these real-world studies, AbbVie also presented an indirect comparative analysis in MDD, long-term pediatric safety data, and patient preference research evaluating treatment approaches following inadequate antidepressant response. "For clinicians, one of the most important questions is whether the benefits demonstrated in clinical trials hold up in the real world, where patients have unique needs, experiences and treatment journeys," said Andrew J. Cutler, M.D., an author of the ProACt study, Clinical Professor of Psychiatry at SUNY Upstate Medical University and Chief Medical Officer of the Neuroscience Education Institute. "These studies reinforce what has been established in VRAYLAR clinical trials and provide additional confidence that meaningful improvements in symptoms, functioning and patient-reported outcomes can be achieved beyond the controlled environment of a trial. That kind of real-world validation is valuable when making individualized treatment decisions in everyday clinical practice." MDD and BP-I can profoundly affect every aspect of a person's life and often require long-term, comprehensive care. Approximately one in five U.S. adults will experience MDD during their lifetime, and nearly 11 million adults are living with bipolar disorder, yet many continue to experience ongoing symptoms despite available treatments - highlighting persistent unmet treatment needs.