Head of Regulatory Affairs, Europe
What’s in it for you?
The Head of Regulatory Affairs – Europe will be responsible for providing strategic direction for Acceleron’s development programs and licensed products in Europe. The individual will be responsible for preparing regulatory development strategies, advise management on regulatory risk, and lead interactions with regulatory agencies on behalf of the Company. This position involves both high-level strategic planning as well as hands-on responsibilities to support the growing pipeline.
What will you be doing?
- Develop European regulatory strategies aligned with business objectives.
- Provide guidance, direction, and leadership on those strategies to the development team and senior management.
- Make regulatory strategy contributions to clinical development plans.
- Assist in the preparation of meeting requests and briefing documents for European health authority interactions.
- Serve as the primary liaison between Acceleron and the European health authorities; coordinate and prepare teams for meetings with regulatory authorities
- Maintain up-to-date working knowledge of laws, regulations, and guidelines across the European regulatory authorities.
- Identify and collaborate with regulatory experts and consultants, as needed.
- Coordinate and prepare responses to requests for information from European regulatory authorities
- Represent the European regulatory function on cross-functional development teams.
- Work with the appropriate partners within Acceleron to establish, update, and implement European regulatory policies, standards, and procedures for the Company.
- Manage the European regulatory aspects of development programs, including achievement of timelines and deliverables.
- Work closely with Global Regulatory Operations to understand electronic submission process and guide the development team with regard to format and content of European regulatory submissions.
- Participate in the review of essential documents, presentations, and reports as necessary.
- Build a European regulatory affairs team in line with Company growth trajectory to support the growing development pipeline and commercial activities.
- Liaise with members of Acceleron’s Quality, Global Regulatory Strategy, CMC, Operations and Ad/Prormo/Labeling groups to advance the Company’s development programs.
What are we looking for?
- An Advanced degree with a minimum of 10 years of relevant regulatory experience in the pharma/biotech industry, and a minimum of 3 years of experience in a senior regulatory role.
- Prior experience with regulatory aspects of protein therapeutics and rare diseases a plus.
- Demonstrated leadership competencies in establishing clear direction and objectives; ability to simplify complex processes and foster an environment that brings out the best in people.
- Excellent working knowledge of drug development process and knowledge of European regulatory requirements
- Track record for having adopted innovative regulatory strategies for novel molecular entities.
- Strong strategic and analytical abilities
- Electronic submission experience
- Excellent verbal and written communication skills
- Ability to provide strong regulatory leadership on a cross-functional team
- Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development.
- Excellent team-building, leadership and management skills
- Excellent listening, communication and interpersonal skills fostering team spirit
- Demonstrated skills in managing direct reports, vendors and others involved in regulatory affairs activities to meet corporate objectives.
- Experience in mentoring staff to develop their skills and ensure they remain challenged professionally.
Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron’s leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its research, development, and commercialization efforts in pulmonary and hematologic diseases. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension (PAH), having reported positive topline results of the PULSAR Phase 2 trial. The Company is currently planning multiple Phase 3 trials with the potential to support its long-term vision of establishing sotatercept as a backbone therapy for patients with PAH at all stages of the disease. Acceleron is also investigating the potential of its early-stage pulmonary candidate, ACE-1334, which it plans to advance into a Phase 1b/2 trial in systemic sclerosis-associated interstitial lung disease (SSc-ILD) next year. In hematology, REBLOZYL® (luspatercept-aamt) is the first and only erythroid maturation agent approved in the United States, Europe, and Canada for the treatment of anemia in certain blood disorders. REBLOZYL is part of a global collaboration partnership with Bristol Myers Squibb. The Companies co-promote REBLOZYL in the United States and are also developing luspatercept for the treatment of anemia in patient populations of myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.