Post Doctoral Regulatory Affairs Fellow - Policy and Intelligence

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Description

The Clinical Development and Medical Affairs Fellow is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to -- Medical Affairs and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require the Fellow to develop competencies necessary to contribute to their respective functional area within a pharmaceutical company. The Fellow will be based at (COMPANY NAME)´s U.S. headquarters in Ridgefield, CT, working on a particular or multiple therapeutic areas (TAs) in the areas of cardiology, diabetes, immunology, oncology, and respiratory. Through a series of rotations either within or outside of the assigned area, the Fellow will also gain an understanding of the broad range of opportunities available to a pharmacist in the pharmaceutical industry. As an employee of (COMPANY NAME), you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect (COMPANY NAME)´s high regard for our employees.

The Regulatory Policy and Intelligence Fellowship is designed to provide pharmacists with exposure to regulatory intelligence and policy activity within the pharmaceutical industry. The position will also offer the opportunity to complete rotations in areas within and beyond Regulatory Affairs.

The Fellow will be exposed to projects involving both US marketed products and investigational projects. Under supervision, the Fellow will:
* Develop, compile, and integrate regulatory intelligence from health authorities, professional groups, publicly available information and BI. * Appropriately communicate regulatory intelligence within the organization.
* Provide analysis, advice, and guidance on US regulatory strategies to promote expedited product development and approval.
* Research information on regulatory policies and departmental policies within and external to RA.
* Research and implement processes to improve regulatory intelligence and collaboration.
* Develop expertise on projects from the regulatory intelligence and policy perspective.
* Collaborate with BI Government Affairs to ensure knowledge sharing of overlapping intelligence topics.

Duties & Responsibilities

Regulatory Expertise:

The Fellow will develop basic regulatory policy and intelligence knowledge across the spectrum of BI assets and marketed products. Interact effectively within Regulatory Affairs and across functions, as a US regulatory advocate to achieve common goals for assigned projects, with supervision.
With supervision, the Regulatory Policy and Intelligence Fellow will:
* Proactively review and evaluate relevant US regulations and guidelines, as well as evolving regulatory trends and developments for their impact on drug and device development activities and on existing development strategies.
* Lead requests for global country-level regulatory information from various partners.
* Handle the development of custom reports to support regulatory compliance and advise strategy.
* Collaborate with partners to support any compliance and process initiatives.
* Own the review and refinement of regulatory FDA guidance and recommendations by developing written comments reflecting BI's priorities for submission to health authorities.
* Supervise the evaluation of new regulatory intelligence data sources and service providers.
* Serve as Regulatory intelligence lead on highly sophisticated cross-functional teams.
* Provide regular communications and briefings to global and regional policy management on relevant global regulatory policy issues.
* Participate in internal product team meetings to provide regulatory policy context for business decisions.
* Provide strategic regulatory advice to RA colleagues on drug development and device projects, registration, and marketed products in preparation for HA meetings.
* Develop training materials and participate as a facility member on new and emerging regulatory requirements for RA colleagues and other line functions.
* Analyze impact of important emerging regulatory policies and new requirements on projects and business.
* Prepare and coordinate internal customer feedback on proposed laws, regulations and guidances, to ensure consideration of BI's positions by trade organizations.
* When appropriate, collaborate with Government Affairs to shape emerging legislative proposals.
* Develop targeted and appropriate automation of regulatory information.

Position Expertise:
* Basic knowledge of pharmacy gained through Doctor of Pharmacy program
* Fellow should have basic understanding of:
* Food, Drug and Cosmetic Act.
* 21 CFR regulations relevant to drug/biologic development and registration.
* Other relevant US laws, regulations and guidance documents.
* Medical, pharmaceutical and scientific knowledge and understanding in the assigned therapeutic area.

Application Requirements

1. Curriculum vitae
2. Letter of intent - focusing on how a fellowship at (COMPANY NAME) can help further your career growth. *Please upload under My Documents, Additional Attachments.

Requirements

* Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned prior to the start date at (COMPANY NAME).
* Ability to perform MEDLINE and EMBASE literature searches.
* Strong intrapersonal, active listening, and problem-solving skills with an ability to work well in a team environment.
* Highly motivated and shows initiative in contributing to team deliverables.
* Receptive to receiving and quickly implementing constructive feedback.
* Ability to work independently within provided guidance from team leads.
* Adaptable and able to contribute to multiple Therapeutic Areas as needed.
* Excellent verbal and written communication skills.
* Proven experience working in a dynamic, high volume environment handling multiple tasks.
* Strong computer skills, including Outlook, Word, PowerPoint, and Excel.
* Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy with an ability to quickly adapt to a changing Corporate environment that will allow the incumbent to be productive in rotational experiences.

Desired Experience, Skills, and Abilities:
* Prior pharmaceutical industry experience (e.g. internship or Advanced Pharmacy Practice Experience [APPE] rotation is preferred but not required