Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Associate Program Directors provide regulatory leadership for one or more regional development projects. Regulatory Program Management Associate Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of medicines for human use. Regulatory Program Management Associate Program Directors are expected to lead their assigned projects and represent PDR to cross-functional teams and groups with supervision. Regulatory Program Management Associate Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners. Regulatory Program Management Associate Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.
Regulatory Program Management
Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics. Briefs teams and management, as appropriate
Provides regulatory expertise and leadership to site and regional cross-functional teams and other groups
Stays abreast of therapeutic area product development and other related business strategies and plans
Serves as the primary PDR representative on one or more regional projects at any one point in time
Analyzes data, the regulatory environment and business objectives to recommend priorities
Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment. Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators
Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development
Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project
Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management
Serves as the site and/or regional principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site and/or regional teams
Provides internal teams with direction on regulatory authority interactions
Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters. Manages RAFT resources
Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made
Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary
Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation
Responsible to ensure all PDR deliverables associated with each project or other assignment are completed within defined timelines and meet regulatory and other company guidelines
Develops regulatory risk management and contingency plans. Communicates plans to management, as appropriate
Works with other functions and functional management to ensure the relevant regulatory team has appropriate budget and resources to meet objectives. Manages or co-manages relevant project budgets to ensure compliance with agreed parameters and provides routine and ad hoc budget reporting and other updates
As relevant, provides day-to-day guidance and direction to less experienced Regulatory Program Management staff and their work supporting the same projects or other assignments
Provides and receives direct and objective performance feedback on/from cross-functional team members
As requested or otherwise appropriate, provides regulatory due diligence assessments in cooperation with other internal groups
Average of 5 or more years’ relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing
Broad understanding of international regulations, processes and issues in drug/biologics development. Includes in-depth knowledge of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines
In-depth experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
Comprehensive understanding of product and safety profiles
Familiar with competitive activity in the field
Experience participating in global product development teams is preferred
Experience as a regulatory contributor for global original IND/NDA/MAA filings in the US or Europe is preferred
Previous people management (matrix management) experience is a plus
Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
Fluent English and other language skills as needed
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process. G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.
Internal Number: 1002
About G&L Scientific Inc
G&L Scientific provides consulting, staff augmentation, outsourcing and support services for Clinical Research and Regulatory Affairs. With our own teams of experts based in our offices across Europe, Asia-Pacific and the US, as well as a pool of more than 2,500 global consultants, the key to G&L’s success is a straightforward, transparent approach; experience of unrivalled depth; and the recruitment and development of brilliant people. Indeed, the level of repeat business and ongoing long-term assignments is testament to the quality of service G&L provides.
Whether our client needs an individual RA professional or full project team, onsite or remote, G&L will design a custom solution that delivers significant savings and flexibility in line with operational demands.
As well as excellence in our chosen fields, we are renowned for the quality of our people. Our real success lies in recruiting and developing brilliant consultants. We seek the right individuals to match our business needs, then build the environment that allows them to fulfill their potential. People join G&L Scientific for a variety of reasons. Some want to work with the very latest developments in Clinical Res...earch & Regulatory Affairs, others want the opportunity to make a real difference working in a dynamic and pioneering team. Ultimately, G&L people are free-thinking, proactive and creative individuals who are not afraid of change.
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