VP Regulatory Affairs

Company Name:
Carlyle Conlan
Client Description:
Our client is a cutting edge pharmaceutical company developing a portfolio of NCE's / NME's with broad anti-microbial and dermatalogic applicability. Our client's patent protected platform leverages proven research as a spring board to create a multitude of potentially meaningful therapies in areas of unmet need.

Opportunity Statement:

Due to the expanding number of indications that are available for clinical exploration, our client has retained us to locate an exceptional Vice President of Regulatory Affairs (VPRA).
Do you consider yourself a regulatory affairs strategist, with documented experience in FDA interactions and leadership?
Are you presently at the Director or Senior Director of regulatory affairs of a drug development company or CRO and ready to take your career to the next level?
Is your philosophy of regulatory affairs driven by scientific evidence and real interaction with the Agency more so than by draft guidance and/or fear?
Are you excited by the prospect of adding value to a world class team and technology that has multiple shots on goal?

The Vice President of Regulatory Affairs is a strategic thought leader who adheres to the highest quality standards and engages in new approaches to strengthen the direction of the organization. The VPRA will serve as the primary regulatory interface with the FDA, other regulatory agencies and the product development teams. This position is expected to provide strategic regulatory leadership on project teams, lead development of the regulatory strategy, and drive regulatory operations. S/he will develop and implement regulatory policies and procedures to support planned activities. The VPRA shall adhere to the client's quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.

Key Responsibilities:
Position responsibilities will include, but not limited to;

Generates and submits regulatory agency applications, reports, and correspondence including INDs, Amendments, Supplements, Annual Reports, DMFs, Briefing Documents, and other correspondence in line with regulatory requirements, guidelines, and GXP compliance.
Reviews all regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards. Implements and identifies new strategies ad directions for regulatory filings.
Manages regulatory projects including overall strategy, resources, costs, time and vendors, if appropriate. Ensures that project work proceeds according to agreed deadlines and maintains status records.
Analyzes complex regulatory documents and advises leadership on applicability and impact on business operations. Maintains regulatory affairs documents and systems including the Regulatory Master File and Regulatory Index History.
Formulates and implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. Provides regulatory guidance to departments and project teams on CMC, non-clinical and clinical programs to support product approval.
Serves as a thought leader who drives results and communicates with leadership in an open and objective manner.
Leads FDA inspection readiness efforts.


BS required. An advanced degree in a scientific discipline, preferred. RAC certification, preferred.

Professional Qualifications
Our client is seeking a seasoned regulatory professional, typically, with 12+ years or more of experience in regulatory affairs, including early stage pharmaceutical development and progressive leadership experience. The candidate will, optimally, have previously created value from a novel platform technology and led development programs resulting in NDA submissions and/or approved products.
In-depth interaction with regulatory agencies and a demonstrated track record of creating regulatory submissions from internal reports.
Expertise in technical/analytical and operational aspects of regulatory affairs, combined with scientific understanding and strong project management. Broad technical knowledge to include CMC, non-clinical and clinical.
Must be process-oriented and have the ability to analyze, deconstruct, develop, institute, and influence processes to support business needs.
Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines. Experience with ex-US regulatory environment, preferred.
Experience in managing, developing, organizing, and maintaining regulatory files. eCTD experience preferred.
Proficiency utilizing standard business tools to manage resources and projects (e.g. MS Project, Office Suite).
Demonstrated Experience
The candidate will have previously worked in a relevant commercial (i.e. Pharmaceutical, Biotechnology, CRO) environment in a leadership capacity driving regulatory strategy. The candidate will have extensive, documented experience of FDA interaction including examples of creativity used in furtherance of submissions.
Demonstrated leadership skills. Ability and desire to work autonomously and within matrixed teams.
Ability to forge excellent, collaborative internal and external relationships.
Passion, energy, personal drive and motivation.
Strategist and implementer.
Ability to anticipate future trends and engage in new, forward-thinking approaches. A challenger of "status quo".
Ability to manage multiple projects and competing priorities in a fast paced, interrupt driven environment.
Excellent communication and analytical skills.
As a professional search firm, we will only be responding to those inquiries that most closely align with the stated requirements. Moreover, our client employer can only review candidates with valid US work authorization at this time. Carlyle Conlan actively recruits and refers applicants for all jobs without regard to race, religion, color, sex, age or national origin.

Please apply directly online at: http://bit.ly/VPRANCE

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