Our client is a young exciting ambitious biopharmaceutical company with an exceptional newly-created opportunity for a bright capable Regulatory Affairs Manager
The Director of Regulatory Affairs is responsible for leading both the strategic and operational aspects of Regulatory Affairs objectives for assigned commercial products, life cycle management initiatives and acquisitions including global regulatory strategy, regulatory submissions, and interaction with regulatory authorities.
? Provides regulatory leadership to cross-functional teams, ensuring cross-functional perspective/expertise is incorporated in regulatory plans prior to decisions being made.
? Assists in the formulation of regulatory strategies to optimize regulatory timings, competitive positioning and opportunities.
? Manages Health Authority liaisons responsible for regulatory strategy, tactics and direction to product development in preparation of submission documents, responses to queries by regulatory agencies.
? Directs the team in developing, implementing and delivering a regulatory strategy for highly complex products which balance time, cost, quality and risk which meets the needs of the company. Drives regulatory aspects of marketed product life cycle management including critical issue management and major line extensions.
? Manages the preparation and timely submission of regulatory documents.
? Presents regulatory strategies to internal governance bodies. Influences internal and external customers as necessary to ensure successful strategy implementation.
? Provides interpretative analyses of complex regulatory guidance documents, regulations, or directives that impact the company's products and operations.
? Ensures quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines and SOP's.
Qualifications and Skills Required:
- Bachelor's degree in Life Sciences, Chemistry or Biology. Advanced degree a plus.
- 12 years previous biotechnology and/or pharmaceutical drug development experience.
- 10 years regulatory affairs experience preferably involving direct contact with regulatory agencies; full knowledge of FDA, EU & ICH regulations and guidelines, and the ability to provide interpretations of the information to others.
- Solid understanding of dossier requirements New Drug Application (NDA), Marketing Authorization Application (MAA) and Clinical Trial Authorization (IND, IMPD, CTA).
- Ability to work with high level contacts and exposure to sensitive information necessitating considerable use of tact, diplomacy, discretion and judgment.
- Ability to strategically interpret and respond to requests from regulatory agencies.
- Experience with effective project team leadership and management oversight.
- Leadership capabilities working across varied cultures, expertise and backgrounds.
- Strong interpersonal skills.
- Professional, proactive demeanor.
- Excellent written and verbal communication skills.
- Action Oriented
- Problem Solving/Analytical
- Functional/Technical Skills
- Priority Setting
- Drive for Results
- Strategic Agility
- Intelligence Horsepower
- Dealing with Ambiguity
Cv to firstname.lastname@example.org 01 2302400 www.rftgroup.ie