Job Description

MilliporeSigma is looking for Specialist - Regulatory Affairs Manager to join our dynamic team and embark on a rewarding career journey. Regulatory Compliance : Interpret and ensure compliance with regulatory guidelines, laws, and standards applicable to the industry. Documentation and Submission : Prepare, review, and submit regulatory documents, including applications, dossiers, and reports required for product approvals or licenses. Strategy Development : Develop regulatory strategies for new products, changes to existing products, or market expansions, considering global regulatory requirements. Communication with Authorities : Interact and communicate with regulatory authorities or agencies to address inquiries, submissions, or compliance matters. Quality Assurance : Collaborate with Quality Assurance teams to maintain adherence to regulatory standards in manufacturing processes and product quality. Risk Assessment : Assess and mitigate potential risks related to regulatory compliance or changes in regulations impacting product development or distribution. Qualifications : Bachelor's or Master's degree in a relevant field (e. g. , Regulatory Affairs, Pharmacy, Life Sciences, Biology, Chemistry, etc. ). Several years of experience (typically 5-10+ years) in regulatory affairs within the specific industry. In-depth knowledge of regulations, guidelines, and procedures relevant to the industry (FDA, EMA, ICH, etc. ). Experience with regulatory submissions, documentation, and interactions with regulatory agencies. Strong understanding of product development processes and quality systems within regulated industries. Excellent communication, negotiation, and problem-solving skills. Key Attributes : Attention to detail and accuracy in regulatory documentation and submissions. Leadership and project management skills for leading regulatory teams or initiatives. Analytical thinking to interpret complex regulations and apply them effectively. Strategic mindset to develop and implement regulatory strategies. Ability to adapt to changing regulatory landscapes and industry standards.