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Director of Regulatory Science

Kelly Services


Location:
Redwood City, CA
Date:
04/19/2018
2018-04-192018-05-19
Job Code:
US15TPJL_BH1426535
Categories:
  • Government
  • Regulatory Affairs
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Job Details

Job Title Director of Regulatory Science

Jobid US15TPJL_BH1426535

Location: Redwood City, CA, 94061, USA

Description **Director of Regulatory Science — Redwood City, CA**

The Director of Regulatory science will develop and shape the strategic direction of the Regulatory group, leading and implementing change projects for improved processes and performance. Oversees operational delivery and efficiency and ensures appropriate resource planning. Supports staff assignment to support drug projects and business improvement projects. Establishes and develops external relationships with key Regulatory stakeholders, leveraging these to maintain competitive advantage.

**Essential Duties and Responsibilities:**


+ Responsible for the development and implementation of the global or regional regulatory strategy for a product/ group of products, and for ensuring that the strategy is designed to deliver a rapid, quality approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, and patients.
+ Oversees product maintenance, supply and compliance activities associated with marketed brands, where applicable.
+ Delivers all regulatory milestones including assessment of the approvability of the program together with risk mitigation measures.
+ Leads the objective assessment of emerging internal and external data against aspirations and update senior management on project risks/mitigation activities.
+ Works collaboratively with the global and local regulatory affairs staff to influence developing views/guidance with leading Health Authorities on specific topics of relevance to their project or regulatory more generally. Ensures effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements.
+ Leads regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
+ Participates in skill-development, coaching, and performance feedback of other regulatory staff.
+ Leads the review of key submission documents and identify any potential risks along with possible contingencies to ensure the earliest appropriate submission and earliest possible approval of key deliverables with advantageous labelling.
+ Creates, communicates and updates the Regulatory Strategy Document for assigned products/projects.
+ Ensures appropriate consultation and Peer Review. Defines the regulatory development plan and own the planning and construction of the global dossier and core prescribing information.
+ Provides regulatory leadership as needed in product license-in/due diligence review, product divestment and product withdrawal.
+ Ensures excellent understanding of the commercial/business goals to contribute as an equal partner with medical and commercial colleagues in cross functional delivery of business objectives.
+ Participates in and/or otherwise supports development and implementation of new or updated Regulatory systems, processes, Standard Operating Procedures (SOPs) or other relevant tools.
**Job Requirements:**


+ BS or MS degree in Clinical or Scientific Discipline preferred
+ Direct experience working as Regulatory Authority interface and leading delivery of regulatory projects through key milestones and investment decisions.
+ Has lead cross-functional teams through key milestones meeting(s) with Health Authorities (preferably FDA), including management/delivery of the interaction.
+ Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company, CMC, SMG, etc., or experience at a health authority.
+ Proven leadership and program management experience.
+ Has assumed a leadership role in a recent, successful major Regulatory submission to FDA and/or EMA/CHMP, such as sNDA/sBLA, NDA/BLA.
+ Consistently demonstrating an ability to think strategically and critically evaluate risks to regulatory activities, taking account of external trends in both regulatory and business environment.
**Apply Today!** Questions? Call Justin at 714.602.1217 or email your resume to Justin.Lynn@kellyscientific.com

**Why Kelly** **®** **?**


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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