Senior Regulatory Affairs Specialist at Merck Group

Responsibilities:

Planning and managing regulatory activities on both new and in-line products in accordance with authorities for a specified portfolio of products accross all countries inthe South East Africa region.

Submit, track and ensure the admission of one or more products especially pharmaceutical in one or more therapeutic areas.

Key accountabilities:

• Work effectively in a mixed environment and users best practices and knowledge of internal or external business issues to improve products or services and to define processes and standards
• Uses advanced analytical skills to solve complex problems or problems that do not have routine solutions and takes a new perspective
• Has in-depth business knowledge and uses understanding of how relevant areas integrate to achieve objectives
• Ensure and verify the standardized functionality and safety of the respective pharmaceuticals according to country specific requirements
• Monitor all legal and admission questions on national and regionallevel
• Develop strategy and define principles and guidelines for the area of responsibility
• The Senior Regulatory Affairs Specialist is responsible for defining and implementing regulatory strategies and submissions in support of new and existing products.
• Interfaces with internal and external resources, and international regulatory affiliates to understand complexregional regulatory approval requirements.
• Responsible for preparation and submission of regulatory documents/applications for new products including but not limited by researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration.
• Responsible for the timely response to Health Authorities requests related to regulatory submissions.
• Responsible for the timely completion of regulatory projects and submission of documentation to regulatory agencies.
• Responsible for compliance with post-market approval regulatory obligations and maintenance of licenses/authorizations for existing products, including review/approval of internal specifications, evaluation of changes in product or processes to determine regulatory impact, and identification of Process Excellence improvements.

Cooperation:

• Guides and influences peers, middle management as well as external customers, suppliers, and agencies, regarding technical issues and challenges within his/her discipline
• Represents Regulatory Affairs on cross-functional project teams to support planning, development, implementation and execution of marketing strategies and ensures alignment with project business goals relating to combination product chemistry, manufacturing and controls (CMC) as well as product labeling issues on a local and global basis.
• Participate in product strategy and positioning;
• Scientific support local business development
• Evaluate current regulatory processes/procedures and identify and implement improvements consistent with Strategy/Process Excellence Principles.
• Assist the Regional and Global Regulatory team in analysing country product data, Regulatory legislation and providing country specific information.
• Ensure product labelling and advertising materials for all products comply with product dossiers and relevant regulations.

Work Experience:

• Requires substantial professional experience (approximately 3years+ as a guide)
• Experience with eCTD submission in South Africa will be an advantage
• The applicant must have regulatory experience in South Africa, Kenya, Tanzania, Uganda, Namibia, Botswana, Mauritius.
• The applicant must be a qualifiedpharmacist registered with the appropriate body in his/her country of residence

JOB-SPECIFIC COMPETENCIES & SKILLS

Specifies personal skills and competencies required

• English and ideally but not essential at least one other language (French or Portuguese).
• Analytical problem solving
• Results and solution orientation
• Quality/Productivity and Customer satisfaction
• Ability to prioritize and work in rapidly changing environment
• Ability to work under time pressure
• Proven project management ability and experience
• Proven understanding of commercial needs and business acumen
• Ability to understand, manage and cooperate in a multi-cultural atmosphere
• Ability to work in teams
• Acceptance to travel nationally and internationally