Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research. With a hugely experienced and successful executive management team this company has a newly created vacancy for an experienced Regulatory Affairs Director.This newly created senior management position will be located in Dublin.
The Head of Global Regulatory Affairs will create vision, strategy and goals for achieving operational excellence within. He will be comfortable with being given a blank sheet of paper and being asked to create an organization from scratch, working in a standalone manner, identifying operational gaps in execution, prioritize, plan, and drive cross functional projects within agreed timelines.
Main functions will include :
- Develop and implements strategic regulatory plans for preclinical and clinical programs.
- Ensure compliance with applicable regulations and guidelines related to preclinical and clinical, regulatory submissions, product launch, labeling, and promotional activities.
- Direct regulatory activities pertaining to Health Authority meetings and negotiations.
- Work closely with development teams, by providing guidance and technical input.
- Provide regulatory support to the business development activities to review potential licensing candidates.
- Provide expertise across global regulatory teams to ensure most efficient processes are implemented and followed.
- Work with the board of the company to identify and manage new regulatory projects.
- Review responses to inquiries from regulatory agencies.
- Develop and implements strategies for the most efficient regulatory filings.
- Responsible for all aspects of US, EU and rest-of-world regulatory filings and post-approval regulatory activities.
- Oversee, coordinate and execute the GRA accountabilities.
- Own the budgetary responsibility for Regulatory Affairs, prepares department budgets and identifies appropriate external resources as needed.
- Ensure that each project initiates with clearly articulated ‘terms of engagement’, has well defined and measurable business results, and is delivered on-time, on-budget and within scope.
- Ensuring training is adequately assessed and performed within GRA.
- Develop SOPs and processes for GRA.
- Ensure that the regulatory department has/maintains up to date knowledge to meet all country and region-specific regulatory requirements.
- Establish, develop and manage internal talent ensuring a balance between internal resources and use of external vendors to ensure flexibility in the delivery of simultaneous submissions globally.
- Experience in the pharmaceutical industry with at least 10 years regulatory affairs management experience in global regulatory affairs.
- Experience of managing staff in a global matrix organization, capable of managing autonomously, of setting the priorities and of creating an organization for the GRA.
- Self-motivated, flexible and creative leader, able to prioritize, multi task and work in a fast-paced and demanding environment.
- Decisive and proactive with hands-on, can-do style and attitude and the ability to prioritize are critical for success.
- Ability to serve as team leader on interdepartmental teams.
- Excellent writing, communication, presentation, skills.
- Demonstrated leadership and project management skills.
- Strong interpersonal and negotiation skills.
- Strong understanding of international pharmaceutical guidelines and regulations.
- Experience and/or knowledge of hormone therapies a plus.
- A proven ability to work under pressure and adhere to deadlines.
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