Regulatory Affairs Manager

Role Overview: As a Regulatory Affairs Manager, your main responsibility will involve monitoring the company's production activities to ensure compliance with relevant regulations and standard operating procedures. You will be tasked with devising strategies for regulation compliance, organizing training programs to educate staff on policies and standards, conducting internal inspections and awareness campaigns, and staying updated on the latest rules and regulations in the industry. Key Responsibilities: - Demonstrate expertise in CMC aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents in adherence to regulatory guidelines, assess changes in CMC documentation affecting regulatory submissions, categorize filing strategies, and compile submissions for various markets including Europe, FDA, and other international regions. - Conduct Due Diligence and develop CMC strategies for complex injectable products to enhance regulatory compliance. - Possess strong knowledge of CMC requirements for EU/US related to solid dosage forms and complex injectables, particularly in Ophthalmic products. - Collaborate with internal and external stakeholders to compile high-quality regulatory submissions within set timelines and guidelines, ensuring accuracy, compliance, and quality of submission documents. - Evaluate change controls concerning their impact on regulatory submissions, categorize filing strategies, compile submissions, and resolve complex issues for EU and international markets. - Utilize strong interpersonal skills for effective verbal and written communication in a collaborative work environment. Experience with ANDA/EU DCP/ IMPD/IND writing is highly desired. Qualifications Required: - MPharm/PhD/MSc in Chemistry/Biotechnology. - 4-8 years of prior experience in the field of Regulatory Affairs.,