The Regulatory Affairs Director is responsible for defining and implementing regulatory strategies to obtain approvals of GSK products in order to support meeting business objectives. The Regulatory Affairs Director must also ensure compliance with global regulations for licenses, post approval commitments, labelling, and risk management and to work on initiatives to shape the regulatory environment oriented to implement in Colombia good regulatory practices.
This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:
Provide regulatory support and assessment of new product introductions under commercial plans and develop and manage product registration strategies in line with business priorities and maximizing the competitive advantages of company assets from development, to launch, and throughout product lifecycle.
YOU will collaborate with cross-functional teams (including Commercial, Medical, Quality and relevant stakeholders) to achieve local business targets and to ensure regulatory strategies and processes are in line with local business objectives and make Interface with Area, Regional and Central Regulatory to develop filing strategy and communicate on current dossier requirements for timely registration submissions.
Moreover, this role will give you the chance to manage country prescribing information and product labelling to ensure maximum competitive advantage and compliance to company labelling policy and local regulatory requirements. You will Ensure that products circulating in the market are covered with valid and up-to-date registrations and all regulatory post approval commitments are complied with.
Finally, YOU will manage communication of major alerts to local authorities with appropriate follow-up as directed by Corporate (with assessment of local risk and regulatory impact and development of issues management plan) and shape the regulatory environment and regulations to ensure positive outcomes through participation and contribution to local industry associations and direct interface with the regulatory agencies on the local and regional levels.
Our Regulatory Affairs area characterizes by being a very innovative and dynamic team, oriented to offer business solutions and open to new ideas to face the regulatory environment challenge. Your team leads the Operation of Colombia and Venezuela Cluster.
We are looking for professionals with these characteristics to achieve our goals:
- Bachelor's Degree in pharmaceutical chemistry, pharmacy or lawyer with regulatory experience.
- 10 years minimum of regulatory experience, including innovation and minimum 2 years of management experience in pharmaceutical companies
- Advance English
However, if you have the following, it would be a plus (Preferred Requirements).
Post graduate studies.
Experience in Regulatory Affairs managing Oncology/Biological products.
If you feel this is your next career move, please apply up to (October 18th)