Global RA Labeling Unit Head
Cary, NC or Europe remote, US
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi USA
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.
What we offer
Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."
Purpose
Lead development and maintenance of global labeling processes ensuring compliance with applicable Health Authorities regulations and guidelines and internal company procedures and business objectives.
Main Responsibilities
Global Regulatory Product Labeling
- Lead activities to define and manage Chiesi’s global labeling development and management strategy with an intended impact to differentiate the products of the company while ensuring compliance on a global level.
- Support successful labeling discussions with Health Authorities globally.
- Lead the implementation of a global labeling development and management strategy, including an thorough understanding of labeling aspects of competitors within relevant therapeutic areas to inform and support competitive labeling
- Implement and manage a process to develop Target Product Labeling (TPL) for support of development of new products and supporting the Target Product Profile (TPP).
- Advise and support the GRA LT and other senior governance bodies on labeling matters and decision
- Support audits/inspections as a labeling subject matter expert.
Promotional Labeling and Advertising Regulatory Compliance
- Lead activities to define and manage Chiesi’s regulatory compliance with applicable Health Authorities laws, regulations and policies related to advertising & promotion of prescription products, specifically in the US and also other major markets.
- Strategically provide direction and clearly articulate any potential risks, along with rationales and anticipated likely outcomes, facilitate productive conversations to develop viable alternatives and solutions to help accomplish the identified goals through an agile way of working and active collaboration with commercial, training, medical, compliance, legal, and the leadership team.
- Provide strategic input into policies, procedures, and training related to regulatory advertising and promotion and marketing compliance.
- Serve as primary contact for Health Authorities for topics related to advertising & promotion of prescription products.
Experience Required
- 10 years in Global or US/EU Regulatory Affairs with 8 years in labeling and/or promotional advertising with excellent knowledge of drug development and regulatory procedures.
- Expert-level knowledge regarding labeling requirements globally, including development and life-cycle management of TPLs, CCDS and of global regulatory authorities.
- Thorough Knowledge of regulatory strategy and clinical studies
- Strategic planning
- Communication
- Excellent knowledge of pharmaceutical development
- Strong project management skills with the ability to handle multiple projects and prioritize work accordingly
- Innovation and forward thinking
- Make effective decisions
- Plan and execute effectively
- Influence and inspire
- Drive results
- Business knowledge
Education
- At least Bachelor’s Degree in Life Sciences
Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
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Nearest Major Market: Eugene