- 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.
- Advanced degree (e.g., Masters, PhD, etc.,) Scientific knowledge in chemistry, general biological/physical science
- Ability to apply that knowledge to regulatory issues and product development having technical complexity.
- Proficiency in a second language is a plus.
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Referral bonus program
Director, Rest of World Regulatory Labeling - Northbrook, United States - Astellas Pharma
Description
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
The Director ROW Labeling Lead will report to the Executive Director, CCDS and Labeling and sit on the labeling leadership team. In collaboration with strategic regulatory, this position will be responsible for regulatory leadership and support (both technical and operational) in the area of CCDS and product labeling for the Rest of World (ROW) Established and International market products in all primary focus areas. This will include new products and life cycle management of existing portfolio. This position will function as a ROW Labeling Lead for Established and International market products 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 have the responsibility of 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 reference member state (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.
Essential Job 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.
Qualifications:
Required
Preferred
Benefits:
Category Medical Specialities TA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans