The Regulatory Affairs Manager, Americas, Global Business Unit Pharma provides regulatory strategy and technical expertise, to ensure the compliance of Roquette pharmaceutical and nutraceutical products. This includes the development and implementation of regulatory strategies for new products and post-approval maintenance of registered products, in alignment with core business objectives. To decrease and/or minimize all associated costs and risks for the Roquette Group in a preventive, proactive and dynamic manner. This role will report to the Head of Global Regulatory Affairs, GBU Pharma and is based in Philadelphia (hybrid).

Geographical scope: North America & Latin America

Key accountabilities:

• Develop, lead, and execute regulatory activities according to the defined functional and business objectives, including the preparation & management of regulatory files and support for authorization of pharmaceutical manufacturing establishments
• Provide technical expertise and regulatory assessments to innovation/R&D and investment projects, and coordinate Regulatory Affairs initiatives within the region
• Recommend, develop, and execute regulatory risk, opportunities, and compliance analysis to support business strategy. Develop and execute mitigation plan accordingly
• Provide regulatory support and guidance to regional manufacturing sites
• Establish close collaboration with internal cross-functional teams and ensure competent execution of agreed business & functional priorities
• Act as Regulatory champion for Nutraceuticals, leading and coordinating all regulatory strategies and topics related to nutraceuticals
• Evaluate and coordinate the impacts of changes to regulatory files: evaluation of change controls, coordination and timely implementation of action plans
• Keep abreast of current regulations and provide timely regulatory advice (including but not limited to GxP) related to product applications, operations and commercialization
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with relevant stakeholders to ensure compliance with local regulations
• Represent Roquette and actively participate in discussions within industry associations and stakeholders, to influence and shape regulations and standards
• Represent RA in various global and international platforms, creating transparency through proactive collaboration within the matrix
• Manage regulatory interactions with external stakeholders: distributors, consultants and partners
• An advocate for regulatory compliance and provide trainings/audits for internal stakeholders, where appropriate
• Support process improvements, SOPs and implementation of best practices

Functional expertise

• Strong experience in Pharmaceutical Regulatory affairs, preferably in API & excipient industry
• Experience in Nutraceuticals & Health supplements regulatory affairs is highly preferred
• Candidate with a combination of Regulatory Affairs and Quality experience can be considered
• Submission of pharmaceutical regulatory dossiers to US regulatory bodies with high degree of accuracy
• Experience in supporting international registrations and cross-regional project coordination
• Strong working knowledge of FDA regulations across full product lifecycle, including knowledge of pharmaceutical development process and medicinal products for human use
• Strong understanding of local regulatory environment (product registration guidelines and processes, GMP, ICH, Pharmacopoeias, etc.)
• Strong understanding of marketing and promotional requirements in Americas/US
• Strong risk analysis and mitigation skills
• Ability to prioritize multiple projects and ensuring all deadlines are met, strong collaboration skill, time management skill and project organization.

Soft skills

• Self-starter and ability to work autonomously
• Resilient and adaptable to changes
• Ability to work in a multicultural, dynamic, fast-moving pace and matrix organization
• Strong attention to details and analytical thinking skills
• Strong problem-solving skills and result-oriented
• Good interpersonal and negotiation skills
• Ability to build and manage internal and external networks
• Ability to communicate effectively in English: verbal and written, in a timely manner within matrix organization

Profile:

Bachelor’s degree in health science, life science, pharmaceutical science or equivalent

Minimum 7 years regulatory affairs experience in US/America region with at least 5 years in pharmaceutical industry. Proven track record of preparation and review of regulatory documentation, and successful management of regulatory file submissions.