Sr. Manager, Regulatory Affairs – Global Labeling | Exciting Growth Opportunity | Innovative Therapies | Top 20 Biopharma | Cambridge/Boston
This is a great opportunity for an industry experienced Regulatory Affairs professional to join a very successful biopharma company focused on the development and commercialization of innovative high-potential new therapies. This is an exciting time as this company is going through a transitional phase, dedicated to continuing to invest heavily in R&D, and well-positioned for sustainable long-term growth/success. In this new Business Unit within the company where you will have the opportunity to grow and really shine within one of the company’s most exciting and highest-profile areas.
Attractive Features about this Company & Opportunity:
- Tremendous Growth Opportunity: Our client is going through an exciting transitional phase, and so you will have a great opportunity and platform here to shine and grow internally.
- Enjoy the Best of Both Worlds: Best of pharma and biotech: join a mid-sized company that has significant financial resources (i.e. cash, revenues, profits..), a strong appetite and for innovation and the perseverance/endurance to make the innovation happen (i.e. willing to significantly invest in its R&D spend and human capital too), and the company also offers a very entrepreneurial and agile work environment where decisions are made swiftly with minimal layers of management.
- Excellent Compensation/Benefits Package: This company offers a very competitive compensation and benefits package.
- Innovative Therapeutics: Work on very exciting therapeutics and be an integral part of bringing innovative therapies with significant potential to market.
- Track Record of Success: Join a company with strong revenues, profits, cash & market cap that invests heavily in its R&D, and is well-positioned for sustainable long-term growth and success.
Responsibilities in a Nutshell:
- Responsible for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Scientific, Commercial, to ensure successful development and maintenance of labeling.
- Ensures that there is strategic labelling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission plans.
- Formulates regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information.
- Provides expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance.
- Drives labeling strategy for this Business Unit via the development and lifecycle management of the CCDS, US, and EU labels.
- Formulates and implements regulatory strategies for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products and global expansion.
- Prepares strategic labeling vision for early development programs.
- Draws on labeling precedent, Health Authority feedback, and guidance, to create innovative labeling strategies.
- Provides guidance on combination product/drug-device labeling.
- Introduces creative solutions for data presentation for consensus by labeling teams and meet the requirements of the Health Authorities.
- Engages cross-functional labeling stakeholders to gain consensus on labeling strategy.
- In close collaboration with the company’s R&D labeling function, oversees the direction, management and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products.
- Project manages new labeling to ensure compliance with internal procedural or Health Authority submission timelines; manages the preparation of submission-ready labeling components.
Education & Desired Experience:
- Bachelor’s degree in a scientific discipline is required. Advanced scientific degree is preferred.
- At least 5 years of relevant experience working in the biotech/ pharmaceutical industry.
- At least a few years of direct experience in a global, US, or EU labeling role.
- Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling, specifically, EU and US labeling requirements and guidance. Combination product/drug-device labeling knowledge is preferred. Advertising and promotion knowledge is a plus.
- Expertise in the development and maintenance of the Company Core Data Sheet, the USPI, and the EU SmPC.
- Experience in plasma-derived therapies or biologics is preferred.
Brian Skurka | Partner
P: 973-656-0220 x738
CORNERSTONE SEARCH GROUP – Pharma & Biotech Executive Search
Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA
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Keywords: Associate Director, Leader, senior manager, Regulatory Affairs, CMC, plasma derived therapies, blood products, hematology, PDT, regulatory agencies, health authorities, Core Dossiers, CTAs, MAAs, NDS, Variations, small molecule, biologics