Regulatory Affairs Labeling Director - SpringWorks Therapeutics
Boston, MA
About the Job
About SpringWorks Therapeutics:
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.
SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.
About the Role:
The Regulatory Affairs Labeling Director will serve as an expert resource for regulatory labeling and will lead the successful development and implementation of labeling for SpringWorks products. This individual will maintain a continued awareness and understanding of FDA, EMA, and international health authority regulations to ensure labeling is compliant.
Location Classification – Remote:
Officially classified as working full-time from employee's home office within the United States or respected region, with the expectation to travel to SpringWorks Therapeutics offices or other locations on occasion as business needs
Key Responsibilities:
- Create and maintain labeling content for marketed product(s) and development products in US and international regions including: CCDS, prescribing information, medication guides, patient information/leaflet/IFU, package label artwork
- Liaise with external partners or distributors in international markets, as applicable
- Conduct research on competitor and other relevant labeling precedents to support high quality, commercially viable labels
- Develop project timelines and manage labeling projects from initiation to completion
- Lead Core Label Working group meetings and provide strategic regulatory guidance, as appropriate
- Author or collaborate with regulatory colleagues on regulatory submissions of labeling documents (package inserts, container labeling artwork)
- Support International Regulatory Affairs colleagues when responding to local health authority queries regarding product labeling
- Help develop, review, and approve global package artwork in close collaboration with Supply Chain, Quality Assurance, and external partners
- Perform other duties and responsibilities as assigned
Qualifications:
- Education: Bachelor's Degree in life sciences or related science degree; Advanced degree preferred.
- 9+ years of related experience within regulatory affairs with a bachelor's degree; or 7+ years of related experience within regulatory affairs with a master's degree; or a PhD with 4+ years' of related experience within regulatory affairs with; or equivalent experience
- Oncology, rare disease, and/or other relevant therapeutic area experience is desirable.
- Experience representing Regulatory Affairs Labeling on cross functional teams
- Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others
- Experience in interpreting regulations, guidelines, and policy statements relevant to labeling
- Comprehensive knowledge of labeling regulations in the U.S. and Europe
- Model SpringWorks Leadership Principles to drive a collaborative function that embraces innovation and drives superior employee experience through growth management.
- Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.
- Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
- Ability to travel occasionally including overnight stay driven by business need.
- This position must be able to work East Coast hours. #LI-Remote
Compensation:
The expected salary range for this position is $167,375.00 - $220,000.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
We offer best-in-class benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases. Interested in learning more, review additional information here Benefits.
SpringWorks Leadership Principles:
- Change Steward - Recognize that change is essential; set goals that align to the Company's strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
- Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
- Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
- Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment
DE&I:
We believe in fostering a culture of belonging. Explore how we are committed to DE&I
EEO Statement:
SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.
This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.
For more information see our Privacy Policy - Springworks (springworkstx.com)
