Senior Regulatory Manager

The Senior Regulatory Manager, Americas, Global Business Unit Pharma provides regulatory strategy and technical expertise, to ensure the compliance of the company’s 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 Group in a preventative, proactive and dynamic manner
• This role will report to the Head of Global Regulatory Affairs, GBU Pharma and is based in PA (hybrid)
• 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 commercialization
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with relevant stakeholders to ensure compliance with local regulations
• Represent the company and actively participate in discussions within industry associations and stakeholders, to influence and shape regulations and standards
• Represent the company 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, SOP’s and implementation of best practices

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Jeff Fee at jfee@cps4jobs.com.

JO:  33.23JF

#LI-JF1

Technical Qualifications:

• Strong experience in Pharmaceutical Regulatory Affairs, preferably in API & excipient industry
• 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 skills, time management skills and project organization
• 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 results-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
• 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

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Jeff Fee at jfee@cps4jobs.com.

JO:  33.23JF
#LI-JF1