Senior Manager, Regulatory Affairs Strategy
Location:
Columbia , Maryland
Posted:
July 07, 2016
Reference:
1034644


About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
Reports to Meridian Director, Regulatory Strategy (Cluster Lead)

Works with internal WSR groups with the Meridian Medical Team in Columbia and relevant project teams. In addition works with relevant development/commercial team representatives within the PGS, and R&D (Worldwide Safety Operations and Risk Management, Worldwide Safety Sciences, Medical, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal).

The purpose of this position is to:
• Generate regulatory strategies that align with the unique business needs of the Meridian Portfolio
• Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.
• Lead teams in FDA meetings related to the development of products in the Meridian Portfolio
• Lead and/or participates in Regulatory Teams for assigned projects/products.
• Understand regulatory environment and communicates priorities to global stakeholders
• Deliver project strategy, risks, label and PRS

Responsibilities
The major duties and responsibilities will include but are not limited to:
• Accountable for ensuring or contributing to Global Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned project/s.
• Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, and minimize resource demands while maximizing overall project delivery time and probability of success and facilitating post filing activities.
• Partners with project teams and other customer groups (e.g., Brand Teams) to ensure required regulatory contributions (line plans, IND, NDA) meet business needs and are provided to the project teams, to agreed time, cost and quality standards.
• Works closely with other Regulatory Product managers within, and across, sites to ensure consistent and appropriate processes, systems, working practices, shared learning and quality standards.
• Implements systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.
• Engages in appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.
• Ensures business compliance and implementation of and adherence to Regulatory standards.
• Develops and maintains constructive working relationship with US Government contacts.
• Develops and maintains constructive working relationship with Health Authority contacts.

Qualifications
Qualifications (i.e., preferred education, experience, attributes):
• Scientific Degree. A higher degree may be an advantage but is not essential.
• 8+ years of relevant experience with proven examples of delivery across the product's lifecycle with demonstrable contribution in Regulatory Affairs.
• Proven ability to manage complex regulatory issues.
• Proven ability to consistently deliver to time, cost and quality standards.
• Regulatory experience including knowledge of NDA/IND, 505(b) (2) submission processes; drug-device experience and prior experience working with CDRH will be an advantage.

Technical skills requirements:
Regulatory Knowledge - Knowledge of the regulatory environment and how this impacts regulatory strategy and implementation. Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting NDAs, INDs. Working with and influencing, opinion leaders, external organizations facilitating approval of submissions.

Therapeutic Area Knowledge - Has working knowledge of the therapeutic area, through prior regulatory experience; direct product development and/or academic training

Commercial Awareness - Demonstrated knowledge of global regulatory procedures and requirements. Understanding of regulatory agency philosophy and guidelines.

Problem Solving and Analysis - Strong problem identification and solving skills, e.g. risk management planning. Strong logical and analytical skills

Communication skills - Communicates effectively using a variety of mediums appropriate to the setting.

Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations

Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

This position is a replacement for a colleague that has transferred to the GCMC group in St Louis. The replacement will be based in Columbia and is intended to be a Senior Manager level, primarily working on the Mylan EpiPen strategy and MCS/BARDA Midazolam registration activities.

EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment.

This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. •1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. •1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.
A little about us:
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