Director Regulatory Affairs Business Operations
Director Regulatory Affairs Business Operations
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$ 180400 - 300700
1 Vacancy
Job Description
This role resides in the Global Development area of Regulatory Affairs Global Patient Safety and Development Quality RA GPS and DQ) and the Director of Strategy Planning and Operations role will work closely with the Senior Director and the broader Strategy Planning & Operations the RA GPS DQ Leadership Team (LT) and the administrative team in support of functional area support.
In this role a typical day might include:
This position will oversee strategic activities including objective and goal setting quarterly reporting resource and budget management team communications aligning interdepartmental and crossfunctional activities and issue management. This role works collaboratively as part of the RA GPS & DQ Strategy and Operations team to drive the functions vision mission and organizational evolution. This role is both strategic and tactical requiring a nimble problem solver and critical thinker with strong interpersonal skills discernment and the ability to shift adeptly between diverse priorities.
This role might be for you if can:
Be accountable for collaborating with all the RA GPS and DQ functional lines and as facilitates the of strategic objectives.
Spearhead implementation of initiatives including project tracking and ensuring appropriate crossfunctional links to other stakeholders.
Support stakeholder management across RA GPS & DQ.
Monitor performance and quality delivery from the functional organization.
Drive the development and tracking of functional goals including coordinating periodic functional reviews collating quarterly status and ensuring issue escalation/resolution.
Facilitate the development maintenance and review of management reports /dashboards enabling decision making and strategic action.
Enable functional resource and budget management activities and support headcount planning and evaluating sourcing models/approaches.
Facilitate resource management and review of demand/capacity.
Partner in developing job descriptions requisition management headcount openings and active postings.
Collaborate with HR to support employee onboarding engagement and talent reviews.
Assist in functional budget management/tracking of spend and liaises with cross functional leadership and Finance.
Lead resource management strategic planning development and implementation of key initiatives.
Own key functional meetings communications engagement & team events. This role involves preparing agendas meeting materials action/deliverable tracking and follow up.
Ensure appropriate communication cascade within/outside the organization in partnership with Corporate Communications and RA GPS DQ Chief of Staff.
Represent the functional Senior Leadership Team at delegated meetings events activities.
May directly supervise administrative support staff for select activities and projects.
Actively participate in operational optimization activities supporting the broader Regulatory Affairs Global Patient Safety and Development Quality department and the broader Global Development department.
Participate in continuous improvement initiatives.
Enrich the team environment reflective of the values of the Regeneron Way.
Key Internal Interfaces:
Regulatory Affairs Global Patient Safety and Development Quality (RA GPS & DQ) Leadership
Development Services and Operational Excellence (DS&OE) areas
Regeneron Corporate Communications
Regeneron Human Resource Business Partners (HRBP)
Regeneron Talent Acquisition (TA) Team
Regeneron Finance
bCALM: Business Contract Administration and Lifecycle Management
To be considered for this opportunity you must have the following:
10 years of pharmaceutical/biotech industry experience relevant planning and operations experience in global development area and specific industry experience in managing and providing oversight of a operational and planning team.
Minimum BA/BS in business marketing finance science/technology or related field. Advanced Degree is preferred but not required; MS/PhD or MBA with experience working within a sciencebased organization /function or in Physical or Life Sciences.
Knowledge of pharmaceutical/biotech operations and an understanding of drug development.
Expertise in MS applications including (but not limited to) Teams Project PowerPoint Word Excel.
Highly organized and detail oriented while also demonstrating the ability to synthesize information and think strategically.
Selfmotivated flexible proactive able to follow through in an ambiguous fast changing environment and proven ability to meet deadlines under pressure.
Demonstrated ability to prioritize and manage multiple projects simultaneously.
Proven ability to work effectively with individuals at all levels of the organization including senior leadership.
Experience in contributing or leading crossfunctional strategic change initiatives.
Excellent interpersonal teamwork and stakeholder management skills.
Strong presentation skills (written/verbal) including the ability to summarize complex information concisely.
Effective influencing and negotiating skills.
Ability to handle confidential information with discretion.
Up to 10 Travel.
#GDRAJobs
Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits which often include (depending on location) health and wellness programs fitness centers equity awards annual bonuses and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion or belief (or lack thereof) sex nationality national or ethnic origin civil status age citizenship status membership of the Traveler community sexual orientation disability genetic information familial status marital or registered civil partnership status pregnancy or parental status gender identity gender reassignment military or veteran status or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Companys business.
For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.
Salary Range (annually)
Required Experience:
Director
Employment Type
Full-Time
