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Sr Director, Regulatory Affairs 9/4/2019

Emergent BioSolutions Gaithersburg, MD

Location
Gaithersburg, MD
AJE Ref #
584759608
Job Classification
Full Time
Job Type
Regular
Company Ref #
28155
Experience
Senior (15+ years)
Education
Bachelors Degree

JOB DESCRIPTION

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Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

JOB SUMMARY

The Senior Director, Regulatory Affairs, will be responsible for Regulatory Policy and Intelligence, Regulatory Processes and Program management, Regulatory Due Diligence for M&A support and Regulatory Operations. The Senior Director, Regulatory Affairs is responsible for providing the strategic direction to the RA department as a member of the Regulatory Affairs Leadership Team and/or global RA teams, as well as building and maintaining high performing RA professionals.

RESPONSIBILITIES

* Establish and maintain Regulatory Policy and Intelligence network to support development of effective Regulatory Strategies

* Proactively monitor evolving regulations and engage in relevant external forums to influence the development of relevant new regulations and guidelines

* Provide overview of evolving Regulatory policy to RA staff and stakeholders to ensure Emergent programs are aligned with the changes in the regulatory requirements

* Direct Regulatory Operations department to ensure submission publishing activities are executed as planned, Regulatory systems and associated processes are operating effectively and as per regulatory requirements

* Lead the Advertising and Promotional Review process and ensure RA functional review is conducted as per regulatory requirements

* Contributes to the modification, development and implementation of company policies and procedures for regulatory affairs with a global, cross-business unit view and works with other functions (QA, PV) to ensure alignment across the business.

* Work closely with Global Head RA, RA staff and cross functional areas to lead the development of processes that are effective in support of product development and post license maintenance and ensures compliance with regulatory requirements

* Lead and Manage regulatory due diligence efforts and engage internal staff and external contractors/ consultants as necessary to support M&A activities

* Establish and maintain external Regulatory support network (contractors, consultants, CROs, etc.) to support the business growth and regulatory resource needs

* Directs a team of regulatory professionals located across Emergent sites; responsible for performance and talent management

* Represents Regulatory Affairs on enterprise cross-functional teams, external industry groups and leadership forums as assigned.

* The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

EDUCATION, EXPERIENCE & SKILLS

* BS degree in related biological and life sciences field (MS or PhD preferred)

* 15+ years of industry experience in Regulatory Affairs for pharmaceutical products in post licensure settings and multiple phases of development.

* Knowledge of global regulations / guidance's and thorough knowledge of drug development process required.

* Experience in global regulatory processes is highly desired.

* Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communication skills

* Strong decision-making abilities

* Demonstrated leadership capabilities, including performance management, conflict resolution, developing talent and proven ability to build effective teams

PHYSICAL / MENTAL REQUIREMENTS

* Type/keyboard, visual acuity, Good eye/hand coordination, sit, hand dexterity, sense of hearing.

* Use phone, fax, copier, and computer.

* Able to organize/ coordinate, analyze/ interpret, problem-solve, make decisions, plan, communicate, and prepare written communications.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.