Regulatory CMC strategist
A well-known international pharmaceutical company with sites around the globe is looking to hire a regulatory CMC strategsit. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology. This role will report into the Europe Regional Lead, Lifecycle and Growth or designee. Accountable for CMC site transfer submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets. This includes HA query management. Job Responsibilities: * Manage CMC post approval manufacturing site transfer submissions for the Europe Region (EU and non-EU) * Manage post approval strategy (including timelines) and execution in alignment and partnership with key stakeholders (i.e. PGS, GRL, CRL, Labelling team, Submissions Management) to ensure a CMC submission ready dossier. * Communicate changes to regulatory requirements and update the appropriate system in a timely manner * Support planning and monitoring activities, update timelines when necessary and communicate changes to the relevant partners * Author local submission components as needed * Ensure submission packages are reviewed against local CMC requirements for consistency and completeness * Liaise with the manufacturing sites for obtaining supporting documents as needed * Ensure thorough understanding and application of PEH RA procedures * Contribute to local and regional regulatory initiatives promoting a culture aligned with company values and which supports compliance, innovation and talent development and retention. * Assist in ensuring internal regulatory processes and procedures are well documented * Identify and support efficiencies across the region through achieving consistency in initial and post approval strategies and its execution * Understand local regulations and trends for assigned marketsSkills and Requirements: * Knowledge of the European and Global regulatory environment and how this impacts regulatory strategy and implementation. * Knowledge of drug development practice, rules, regulations and guidelines. * Strategic and analytical Thinker * Communication skills * Negotiation and influencing skills * Problem Solving * Understanding stakeholder needs * Team working * Strong quality and compliance orientation * Change agile * Risk management * Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences. * MSc, MBA or PhD may be an advantage * Prior experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or Compliance * Strong knowledge / background of EU (EU and non-EU) regulatory procedures and requirements * Experience in regulatory affairs or compliance preferably in human medicines - minimum 5 years of experience. * Demonstrated regulatory experience with a pharmaceutical company with proven examples of contribution. * Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards. * Regulatory experience including knowledge of Europe submission product lifecycle management processes. * Demonstrated experience of effective delivery in a matrix environment.To Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.proclinical.com. A full job description is available on request. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.