The primary responsibilities of this role, GlobalRegulatory Strategist, are to:
Be actively involved in decision making on all keydevelopment questions as a member of the project team (as alldecisions impact the Regulatory dossier and approval processes,i.e. preclinical and clinical study and program designs, licensing,etc.);
Be responsible for achieving assigned regulatory projectgoals, milestones and labeling, from development through lifecycle;
Represent worldwide Regulatory Affairs on assigned GlobalProject Teams or represents a region in close cooperation with theGlobal Regulatory Strategist (GRS) who is the Global Program Team(GPT) member.
Ensure submission and approval of clinical trialapplications to enable timely start of the clinical trials for theassigned development products;
Give Regulatory Advice on Clinical Trial design based oncompetitor intelligence and guidelines and Agency meeting strategyfor evaluation of major clinical trials;
Be responsible for the Regulatory Strategy for assignedprojects by designing and assessing regulatory strategy options ona regional and global basis (as outlined in the Global Regulatoryplan), ensuring
active feed-back from, and robust agreements/approvalswith/by, regional and functional Regulatory Core Team (RCT)members, Bayer internal functions involved in the development andlife cycle process as well as external regulatory advisors inacademia;
Develop the initial target labeling (and competitorlabeling) in close cooperation with Global Regulatory Affairs (GRA)Global Labeling;
Responsible for identifying the overall Regulatorydirection for appropriate development plans and optimized approvalchances of the agreed target labeling;
Own the Regulatory Risk assessment in alignment with GRAmanagement;
Keep abreast of changes in the Regulatory environment forthe project to anticipate necessary adaptations;
Actively contributes to strong Issue Management as amember of an appropriate sub-team;
Ensure early identification of major Regulatory Issuesrelating to clinical, technical, strategic or operationalinformation impacting successful Clinical Trial Authorizations,and/or Marketing Authorizations Applications/approvals for assignedprojects;
Identify corrective regulatory measures and immediateactions required in case of deviations jeopardizing global ProductDevelopment(PD) product goals;
Communicate and manage these regulatory measures in allmajor all major global markets via the Regulatory Core Team membersand/or local Bayer regulatory departments;
Be responsible for achieving assigned global regulatorymilestones and owns the regulatory risk assessment for thesemilestones;
Be responsible for all communication with the regionalhealth authority in the assigned region for his/her specificprojects, keeping track of all communications and requests inappropriate contact reporting databases and ensure appropriateinternal and external communication of all Regulatory relevantissues;
Develop the Health Authority meeting plan for validationof development programs at different stages in close co-operationwith GPT and RCT in alignment with Regulatory Affairs (RA)management;
Lead the development of the briefing document for theHealth Authority meeting he/she is responsible for;
Represents Global Regulatory Affairs at major Board ofHealth (BoH) meetings for assigned projects (GRS who is a GPTmember as well as Regional GRS);
Lead a Global Regulatory Team (GRT) and coordinateworldwide regulatory input into the global development plan forassigned projects. The GRT is chaired by the GRS with globalresponsibility;
Ensure that the target labeling, and Regulatory StrategyPlans address the needs of the specifically assigned region(Global/U.S./E.U.);
Be responsible for creating and/or managing a strongnetwork for assigned projects with the health authority in theassigned region, and other key regulatory influencers andstakeholders, that facilitate the incorporation of regulatoryintelligence and influence into the regulatory project strategywith the goal to increase overall approval chances;
Be responsible for building and maintaining an overviewof available documentation for assigned projects via a database orequivalent tracking tool in close cooperation with GlobalSubmission. This includes all regulatory documents needed tosupport and maintain Clinical Trial Authorizations (InvestigativeNew Drugs (INDs), CTX, etc.) and/or Marketing Authorizations (NDAs,MAAs, NDS, etc) in line with current Regulatory standards andguidelines;
Be responsible for leading or facilitating the BayerGlobal Review for assigned project submissions to finalize andapprove Clinical trial (i.e. IND) and Marketing Applicationsubmissions dossiers (i.e. NDA);
Be responsible for maintaining the Bayer globalregulatory position for assigned projects in preparation andcoordination of all responses to worldwide health authoritydeficiency letters;
Actively monitor that the company meets allpost-marketing commitments in close co-operation with thefunctions;
Co-ordinate all Regulatory matters with license partnerin Joint Development Committees;
Evaluate new strategic concepts and license opportunitiesfor the product;
Review of promotional material on global level (Interfaceto promotional integration team);
Where applicable, coordinate the activities of a smallgroup of Global Regulatory Managers assigned to major developmentprojects.
Who you are
Your success will be driven by your demonstration of ourLIFE values. More specifically related to this position,Bayer seeks an incumbent who possesses the following:
Advanced technical degree (Ph.D., M.D., D.V.M. orPharm.D. in life sciences with 10 years industry experience inmedical research activities of which 2 5 years includeglobal regulatory experience in related therapeutic area or 5 yearsof local regulatory experience in a highly drug-related country ORMS degree with 10 years industry
experience OR BS degree with 14 years industry experienceof which 2 5 years of local regulatory experience in ahighly drug related country;
Must have expert knowledge of the region he/she will beresponsible for US,Europe, Middle East Africa/Food and DrugAdministration (EMEA/FDA) regulations on Clinical trialsapplications and drug approval regulations);
A working knowledge of foreign regulations as well as ofadverse drug event reporting requirements;
Broad experience and communications skills;
Must be able to knowledgeably discuss and effectivelydeal with, as well as provide training, on issues such as productsafety and drug regulation compliance with Bayer medical staff,clinical investigators, marketing staff, quality assurance staff,Bayer medical and coordination staff, EMEA/FDA and responsibleindividuals in other pharmaceutical companies;
Managerial abilities in order to direct and develop staffand to guide and implement international clinical compliancestrategies and training, where applicable;
A thorough knowledge of company policies and proceduresin drug development and maintenance is essential as well assensitivity to the diverse cultures comprising the globalRegulatory community;
Must have demonstrated originality in problem solving asapplied to drug Regulatory issues and have skills and experiencedealing with drug Health Authorities;
Scientific and technical expertise, including the abilityto develop robust regulatory plans covering all phases of drugdevelopment;
Strong analytical skills are necessary to interpretregulatory data and make critical decisions;
Will be required to focus on multiple issues at one time,and must have the ability to organize and direct diverse activitiesin a changing environment often under time pressure;
Strong management skills are necessary for the leader ofa global regulatory team operating in a matrix environment and,where applicable, coordination of a small group of GlobalRegulatory Managers;
Leadership, motivational, interpersonal and issueresolution skills;
Additional skills in gathering decision information,negotiation and communicating decisions and action, and a furtherlevel of complexity is added by virtue of working across manycultures and time zones. In many cases, competing objectives willhave to be harmonized and reconciled to achieve the overallobjectives;
Well-developed leadership and project management skills,including demonstrated cross-functional communication,interpersonal and influence-management skills.
Working knowledge or experience in developing PRO Toolsin collaboration with Health Authorities.
In-depth knowledge, domestic and foreign, of clinicaltrial methodology, clinical auditing procedures, and drug safetydata collection;
A working knowledge of medical procedures, drug therapy,statistical concepts and the collection, computerization andreporting of data collected in clinical trials.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the \"Passion to Innovate\" and the \"Power to Change\", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.