Job Title: Northern European Regulatory Affairs Manager
Job Type: Permanent
Location: Berkshire
Deadline:
30th Aug 2013
Start Date: ASAP
Salary: Competitive Package
Ref No:
267641-NEU_REGS_01
Principal Accountabilities
*Support regional management and commercial team and assist EU regulatory director, to manage local regulatory professionals to obtain and maintain all necessary pharmaceutical Marketing Authorizations (MA), price agreements and appropriate licenses/authorizations.
*To ensure approvals for narcotic drug business in compliance with individual health authority and local government regulations.
*Liaise directly with local health authorities to develop and lead NEU regional regulatory strategies for product categories in line with global strategic plans.
*Ensure the registration and regulatory compliance of locally marketed products to bring competitive advantage to our brands. Amend registration 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 and informed early enough of significant regulatory expected changes and potential 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, clinical, marketing, advertising, labelling and production of our products.
*Work with regional and country commercial teams & provide support to local drug listings and promotional material copy clearance activities.
*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 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.
*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.
*Provide regulatory supports to activities related to SOPs & training programs and regulatory compliance in the areas of regulatory affairs and pharmacovigilance. As provide local regulatory assistances to support commercial activities such as product release, QA/QC functions, supply chain issues, promotional material copy clearance. Maintain a dialog with Quality Assurance and Manufacture personnel to share information and ensure best practices.
*Support and lead internal and external Audit initiatives for the region
Key Challenges
*Ensure a balanced approach to meeting regulatory compliance and supporting the commercial teams to deliver the needs of the business and patients
*To take leadership within a cross functional management team to drive forward regulatory projects and initiatives for the region
*Ensuring a pragmatic approach to business decisions and challenges in a highly commercial and complex regulatory environment
*Possessing a strong knowledge and understanding of pharmaceutical regulations concerning the narcotic drug business in individual European countries and surrounding regions. Thorough familiarity with the process of obtaining and maintenance of pharmaceutical MA approvals & narcotics licenses, MA variations, and Aggregate report reporting.
*Working with remote multinational teams to define and drive regulatory
*Possessing strong reasoning ability to lead or/and support and prioritize projects, adapt to shifting priorities, and resolve problems/conflicts. Skill at research, logic, objectivity, and good judgement, as necessary, to formulate supportable opinions rapidly.
*Managing the production of necessary regulatory and technical documentation to meet the exacting demands of regulatory authorities.
*Meeting regulatory and project deadlines in a performance-driven environment
*strategy/tactics required to secure desired global positioning.
*Dealing with changes that require regulatory action with the added complexity of multiple national registrations, controlled ethical drug products, and socio-politically sensitive indications and therapeutic areas.
*Articulating technically sound scientific/regulatory principles that support best practices.
Professional Qualification / Experience / Specialist Requirements
*Advanced degree in Pharmacy/Chemistry/Biology or other science-related field.
*A minimum of 5 years experience in the pharmaceutical regulatory is requiringd.
*Working knowledge of key health authorities in Northern EU and surrounding eastern European countries (Ideally)
*Experience of leading and managing regional projects.
*Strong project management skills (including vendor management)
*Experience in narcotic pharmaceutical business is a preferred
Personal Attributes
*Results and action oriented, entrepreneurial, and self-motivating.
*Solution orientation
*Ability to think and act strategically not only regulatory wise
*Leadership and interpersonal skills capable of building strong working relationships and collaborative in approach in commercial environment
*Intellectual sensitivity and strategic thinking that ensures the patient is held at the centre of business plans and actions, as well as ability to
If you are interested in learning more please call me on 0114 209 6321 or feel free to send across your CV to ssmith@acr-uk.com
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