Do you have the drive and ambition to join a dynamic young fast-growing company offering exceptional career development opportunities?
Our client is a young exciting multinational biopharmaceutical company enjoying exceptional growth combined with a strong high potential pipeline. Rapid expansion has led to the need to create a management position in Regulatory Affairs to be based in their Dublin office.
The Regulatory Affairs Manager shall work closely with and assist the Director of Regulatory Affairs in providing regulatory intelligence support, strategic regulatory advice, compiling regulatory submission packages and executing submissions to regulatory agencies in Europe and worldwide (where required) in a timely fashion to support all markets.
- Assists in the scheduling, coordination, preparation, and submission of regulatory application (MAAs, variations, scientific advice applications…etc.) to the EU, UK and global authorities where required, expeditiously and to the highest standards.
- Supports the regulatory department in responding to regulatory questions from within the company and from external sources such as health authorities.
- Provides input on regulatory strategy for new and existing regulatory programs within Europe and ensure that all statutory regulatory requirements are adhered to.
- Reviews product labels and ensures that European labels and Patient Information is approved for use.
- Maintains various regulatory tracking databases such as workstream trackers, variation trackers and medicines agency correspondence logs.
- Participates with multidisciplinary teams in the preparation and planning of health authority interactions (EOP2, Scientific advice, pre-submission meetings, etc.), including organizing rehearsals and assisting in the compilation of briefing documents.
- Collects, reviews, organizes, assembles and checks data, reports and summaries to assure full compliance with regulations, guidance documents and past regulatory interactions and commitments.
- Assists in activities related to regulatory applications (e.g., annual reports, PSURs, DSURs, PADERs, CTAs, amendments, variations) to ensure compliance with governing regulations, and company policies and standards. Works closely with functional areas in a team setting to quickly provide guidance and feedback.
- Maintains current knowledge of global regulatory requirements and assists in gathering regulatory intelligence for planned clinical investigations as well as strategic marketing applications in various worldwide regions.
- Ability to recognize and identify regulatory risk.
- Assists in reviewing and updating regulatory standard operations procedures (SOPs) to ensure compliance with Health Authorities regulations.
- Supports company efforts in preparation/responses to regulatory inspections.
Degree qualified advanced degree preferred. With three - Five years’ pharmaceutical experience in regulatory affairs. A solid knowledge of the drug development process, and European regulations and guidelines pertaining to marketing authorisation applications, variations and product labelling. Relevant experience across therapeutic areas in providing regulatory intelligence support to effectively facilitate strategic decision-making. Ability to work across several key projects.
Excellent oral and written communication skills, organizational abilities and team skills are essential. Results oriented; thoroughness; conceptual and analytical thinking; critical information seeker. Concerns for standards. Possesses a can-do, solutions-oriented attitude.
- Strong communication skills
- Strong IT skills
- Excellent organizational and analytical skills.
- Process orientated.
- Ability to make decisions independently as well as with a team.
- Must have ability to interact and work well with others and manage non-reporting resources.
- Must be an independent and critical thinker.
- Well-developed electronic and oral presentation skills.
- Proficient in MS Office
- Demonstrated success working collaboratively and effectively within a global matrixed contract manufacturing / supply environment.
- Must be flexible and adaptable in constantly changing environments.
- Able to lead and move projects forward with initiative, being comfortable leveraging experience to create clear plans with minimum direction.
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