Job Description
Job Spec
- Provide regulatory leadership on project teams and working collaboratively with the project teams to identify optimum regulatory strategies for assigned projects.
- Lead teams in examining regulatory strategy options and relevant regulatory guidance and precedent.
- Identify and assess regulatory risks associated with development programs and define strategies to mitigate risks.
- Monitor and analyze appropriate regulatory agency activities in areas of interest to the company and assess potential impact on programs. Able to take a global view on regulatory strategy and help teams navigate different regional requirements and the interplay between key regulatory agencies.
- Interact with regulatory authorities, and outside consultants when needed.
- Oversee and manage external regulatory and development vendor resources.
- Prepare and lead a team through a regulatory meeting.
- Write, review, and edit regulatory documentation, ensuring it is fit for purpose, and to serve as a resource for regulatory document authors regarding the appropriate content of submissions.
- Reviews submissions to identify adequacy of sections, completeness and consistency of story and overall content of submissions, may be responsible for authoring submissions when needed
- Represent departmental function, acting as primary interface with regulators, presenting strategies, and negotiating solutions, and may lead and coordinate intra- and inter-company projects
- Communicates regulatory strategy effectively to all departments, senior management, regulators, and regulatory agencies to achieve timelines
- Supports 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 USA and ensure that all statutory regulatory requirements are adhered to.
- Maintains various regulatory tracking databases and agency correspondence logs.
- Participates with multidisciplinary teams in the preparation and planning of health authority interactions (EOP1/2, Scientific advice, pre-submission meetings, orphan applications, 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, DSURs, CTAs, amendments,) 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 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.
Person Spec
Degree qualified advanced degree preferred. With significant years’ pharmaceutical experience in regulatory affairs ideally with ATMPs. A solid knowledge of the drug development process, and European and USA regulations and guidelines pertaining to ATMPs. Relevant experience across therapeutic areas in providing regulatory intelligence support to effectively facilitate strategic decision-making. Ability to work across several key projects.
Specialized knowledge that would be desirable and supportive of success in this position includes:
- Understanding of regulatory requirements for and hands on experience with submission of applications for ATMPs (e.g., INDs, NDAs, CTAs)
- Extensive experience partnering with CROs on regulatory submission activities
- Experience working on development programs and driving regulatory strategies specifically relating to clinical, pre-clinical and CMC aspects of the project.
- Ability to create and manage detailed timelines and/or experience with tracking regulatory activities across disciplines and territories
- Experience in other key functional areas, (e.g., toxicology, pharmacology, chemistry/manufacturing, clinical research) appreciated
- Experience in orphan drug development and understanding of EU/US regulations related to and orphan requirements
- Demonstrated track record of success building relationships with, and influencing, regulatory agencies, particularly in situations requiring direct interaction/negotiation
- Experience working in a global team environment.
Required Competencies – Knowledge, Skills, Abilities
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 with the following specific skills:
- 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.
- Demonstrated success in the management of regulatory submissions such as IND and CTA applications for ATMPs
- Nimble learning and able to actively seek out relevant legislation and competitive information on products
- Willingness to take ownership and accept responsibility, ensuring accountability for actions and decisions
- Must be detail oriented, well organized, and able to work both independently and in teams
- Demonstrated ability to communicate effectively both verbally and in writing
Gerry Kennedy, Managing Director, Recruitment for Technology Ltd. Cv to gerry@rftgroup.ie
Maple House, South County Business Park, Leopardstown, Dublin D18 F863