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.
