Current Opportunities

Tracking # 55 Industry Pharmaceutical Jobs Job Title CMC Regulatory Manager Location United Kingdom Salary Open Job Description To support and implement the regulatory CMC strategy in Europe and in other countries (as applicable), in order to secure and maintain marketing authorisations. EDUCATION: · Educated to honours degree level in Chemistry, Biological Science or Pharmacy. An advanced degree is desirable. SPECIAL KNOWLEDGES, SKILLS AND ABILITIES: ·Successful candidate will be experienced in the day to day CMC project management of regulatory affairs in a busy commercial setting with a minimum of 5-10 years experience. ·Minimum experience within the pharmaceutical industry to include proven successful management of regulatory submissions (NDA, MRP/DCP, centralized), new product regulatory submissions, product licence management including renewals, variations, regular dealings with Regulatory Agencies (MHRA or within Europe). Experience of CMC regulatory issues throughout the life cycle of a product. ·Ability to work effectively with minimal supervision. ·A strong background knowledge of the ICH quality dossier requirements and preparation. An understanding of quality control processes, batch release, working with Qualified Persons in product manufacture desirable. ·Must have good computer skills with an in-depth knowledge of MS Word, MS Excel Adobe Acrobat and Microsoft Project, and scanning. ·Must have excellent organizational skills. ·Must have a very high attention to detail. ·Ensure a high degree of standardization, efficiency and quality is met and maintained. ·Electronic submissions experience highly desirable. ·Experience with Documentum highly desirable. PERSONAL ATTRIBUTES ·Ability to think strategically and be innovative. ·Able to join a successful existing team and work seamlessly with existing team members. ·Excellent organisational and time management skills. ·Ability to assimilate data from diverse sources and construct lucid argumentation from that data. ·Clarity of written and verbal communication. ·The business language is English, therefore fluency in English is essential. ·Flexible to travel, if required. ·In line with our clients core values, the candidate will be achievement focused and able to work in a direct and often pressurized environment. Entrepreneurial skills in terms of innovation and problem solving are key along with tenacity, tough-mindedness and ability to influence and demonstrate strong team working abilities and commitment. PRIMARY RESPONSIBILITIES ·Develop and lead a CMC regulatory strategy for product categories in line with global strategic plans. ·Ensure the registration and regulatory CMC compliance of locally marketed products to bring competitive advantage to our clients brands. ·Amend registration quality dossiers as necessary for country-specific regulatory requirements and submit registration applications and negotiate with governmental authorities to obtain rapid approvals with favourable labelling and claims. ·Monitor and interpret local regulatory issues and trends that will impact the marketability of company products and ensure that the company is aware of significant regulatory issues. ·Interface with local government agencies and industry associations to assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labeling and production of our products. ·Represent company interests with local government agencies, industry associations and/or other organizations for the purpose of negotiating legislation, regulations and/or guidelines that do not impose excessive or unfair burdens on our industry or products. ·Support the development and maintenance of a database of local regulatory requirements accessible to the global team. ·Provide regulatory and product compliance expertise in the area of advertising and label claims for existing and new products, as applicable. ·Support internal investigations into allegations of non-compliance and the activities necessary to expeditiously resolve local regulatory disputes; support internal audits and where necessary, audits performed by 3rd parties. ·Provide technical support to respond to consumer and legal inquiries on regulatory issues for our products marketed locally. ·Report measures of product registration and regulatory compliance performance. ·Assist with local statutory reporting requirements. ·Provide regulatory documentation required by other functions or company businesses. ·Provide technical guidance to Regulatory Associates. Relocation Package Yes Interview Expenses Yes Benefits Package Yes