Senior Manager, Lead for U.S. Regulatory Policy
3 weeks ago
PPTA seeks a Senior Manager, Lead for U.S. Regulatory Policy to lead PPTA’s U.S. regulatory policy strategy and engage with Federal and State regulators such as the FDA, HHS, state department of health and regulatory and science policy agencies, such as the CDC.
As part of the Global Regulatory Policy team, the Senior Manager will collaborate on U.S., Europe and rest of world issues of a regulatory and policy nature impacting the plasma-derived therapies industry.
Essential functions:
- Lead PPTA’s U.S. regulatory policy strategy.
- Identify, evaluate, and report on current industry issues of a regulatory nature which impact the industry.
- Manage and collaborate on the development of industry white papers, advocacy materials, position papers, industry standards, scientific/regulatory guidelines and recommendations based on industry consensus.
- Proactively build and maintain relationships with government agencies (U.S. DHHS, FDA, CDC, and others), peer groups, other trade associations to obtain insights and help shape the regulatory landscape.
- Coordinate and lead outreach activities to foster a beneficial regulatory environment.
- Support Association-related activities with regulatory agencies and peer groups on Federal and State government initiatives related to blood/plasma products industry and work with Association committees to develop consensus positions and or industry guidelines.
Other duties and responsibilities:
- Develop and coordinate industry positions on existing, new, and emerging issues.
- Collaborate with Association committees to identify, define, develop, and implement strategic initiatives that enhance the industry's U.S. regulatory environment.
- Organize, assist, and follow-up with industry and U.S. government and other external stakeholder meetings.
- Prepare internal and external presentations and other communication and participate in advocacy and outreach events on priority regulatory policy issues.
- Write articles and contributions for newsletters, journals, and social media.
- Work with senior government relations staff in the development of strategic plans and public policy positions.
- Work with global regulatory policy staff on U.S., Europe, and Rest of the World issues of regulatory and policy nature.
Qualifications:
Education
- Minimum Bachelor’s degree, preferably in the life sciences.
- Advanced degree in public policy, law, life sciences, or equivalent experience desired.
- Regulatory Affairs Professional Society (RAPS), Regulatory Affairs Certification (RAC) or alternate certification desired.
Experience
- 5+ years significant experience in regulatory affairs, or appropriate relevant experience.
- Experience working with a Federal and/ or State government regulatory agency, biologics (blood or plasma) or pharmaceutical industry trade association or standards-setting body. Experience in plasma-derived therapies industry preferred.
- Strong understanding of biologics or pharmaceutical-related health policy, public policy, government affairs experience desired.
- Strong professional network of biologics/pharmaceutical regulatory policy, trade association, and/or policymaker professionals desired.
- Alternative combinations of education and experience will be considered.
Skills & Abilities
- Excellent written and verbal communication skills, ability to concisely summarize regulatory policy issues and advocacy points.
- Ability to understand compliance, regulatory affairs, product development processes and product life-cycle management, standards/certification and compliance requirements.
- Strong interpersonal skills, including influencing skills, persuasiveness, and a sense of diplomacy.
- Ability to network and build rapport with a wide array of industry representatives and create a collaborative environment.
- Strong team player.
- Strong strategic and critical/analytical thinking and ability to apply knowledge to regulatory and government policy development.
- Willingness and curiosity to develop additional knowledge in areas such as biologics regulatory requirements in the European Union and Rest of World, industry standards, donor health, patient engagement and others.
- Program/project management mindset.
- Some business travel required (10-15%).
Salary and Benefits:
- Base annual salary range: $110k to $130k - dependent upon individual qualifications.
- Benefits: Health, Vision, Dental, 401k, Life/Disability, Fitness, Hybrid Work – 3 days in office, Bonus plan
How to Apply
Interested candidates are requested to submit their resume and cover letter by attachment to an e-mail to cizzi@pptaglobal.org, to the attention of Cathy Izzi.
In case of questions, please do not hesitate to send an e-mail to cizzi@pptaglobal.org.
Working at PPTA
PPTA maintains a respectful culture and environment that fosters inclusivity, diversity, collaboration, equity, and innovation, and reflects the global communities we serve. We encourage every team member to contribute innovative solutions toward meeting our goals and objectives in support of our Mission. We respect the work-life balance necessary for the best performance of each team member to drive broad and reliable access to high-quality plasma protein therapies, with a focus on the well-being of patients and plasma donors.
About PPTA
The Plasma Protein Therapeutics Association (PPTA) is the global industry trade association representing the private sector collectors of source plasma (plasma for manufacturing) and manufacturers of plasma-derived therapies. As a trusted partner to health systems, PPTA drives broad and reliable access to plasma derived medicinal products with a focus on the well-being of patients and plasma donors. These therapies are used by small patient populations worldwide to treat a variety of rare diseases and serious medical conditions.
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