Director, Rest of World Regulatory Labeling

Found in: Talent US C2 - 2 weeks ago

Northbrook, United States Astellas Pharma Inc. Full time
Responsibilities :

This position will function as a ROW Labeling Lead for ROW Established and International products in all primary focus areas and will be responsible for all aspects of labeling development including creating, updating, and maintaining labeling content documents throughout the product lifecycle. This position will help maintain controlled records for historical, current and ending labeling changes. This position will manage labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.

This position will also act as the ROW Labeling Lead providing oversight to other Regulatory personnel including regional implementation leads who are responsible for developing or managing labeling content and ensure consistency to RMS labels as appropriate. As needed, this position will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process. The position will understand and incorporate all key labeling guidance’s in established and international markets, into labeling strategies for those regions.

This position will participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans. This position will assess impact of new labeling regulations and implement appropriate changes as well as lead development of company policy and position on draft regulations and guidance. This position will interact cross-functionally with members of RA, asset team, commercial, legal, safety, medical and others.

Key responsibilities include ROW labeling development and implementation, across Astellas products. This position will also be responsible for ensuring quality documentation processes and QC of all labeling documents.

Quantitative Dimensions:

This position will have direct impact on the implementation of new labels and changes of CCDS, and labeling, management/coordination of regional strategies of local labeling regarding implementation of CCDS updates, and labeling compliance for all Astellas marketed products in the Established and International market regions. This position will have impact on the successful registration of new products, indications and line extensions.

Organizational Context:

This position will independently interface and effect decisions with local and global team members (e.g., Pharmacovigilance, Medical Affairs, and affiliates members). The position reports to the Executive Director, CCDS and Labeling, Regulatory Affairs. The individual may have direct reports at the Associate Director and Manager levels.

Requirements

Qualifications:

Required

Bachelor's degree (preferably in a life sciences field) with preference to higher degree.Relevant experience in Regulatory Affairs in the area of labeling development and review for prescription pharmaceuticals or similarly regulated industry required (10 + year of relevant experience).Excellent planning, organizational, analytical, problem-solving, and decision-making skills.Ability to lead and motivate others.Ability to drive projects to completion.Possesses a working knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of product labeling and packaging.Ability to exercise sound judgment and operate with a high degree of independence regarding routine and non-routine assignments.Possesses excellent written and verbal communication skills.Strong computer skills, including a working familiarity with electronic document management systems for compliant maintenance and version control of submitted, approved and in-use labeling.

Preferred

Advanced degree (e.g., Masters, PhD, etc.,) Scientific knowledge in chemistry, general biological/physical scienceAbility to apply that knowledge to regulatory issues and product development having technical complexity.Proficiency in a second language is a plus.

Benefits:

Medical, Dental and Vision InsuranceGenerous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks401(k) match and annual company contributionCompany paid life insuranceAnnual Corporate Bonus and Quarterly Sales Incentive for eligible positionsLong Term Incentive Plan for eligible positionsReferral bonus program

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