General Information

Job Advert Title: Associate Director, Regulatory Affairs Labeling Strategy

Location: Nihonbashi, Tokyo

Division: Regulatory Affairs

Employment Class: Permanent

Description

Purpose & Scope

Collaborate with strategic regulatory for development of regulatory strategy and support in the area of CCDS and product labeling for products in development programs as well as life cycle management of existing portfolio for key country labeling. Provide oversight to other Regulatory personnel including regional leads and ROW labeling implementation leads who are responsible for developing labeling/packaging or managing labeling content and ensure consistency across product labels.

Advise global internal stakeholders and business partners on best practices regarding planning and execution of labeling strategies. Collaborates to assure labeling-relevant aspects of global and local regulatory strategies reflect best in class applications and meets all applicable regulatory and business requirements.


【Essential Job Responsibilities】

• Functions as the CCDS Labeling Lead responsible for leading the creation, implementation and maintenance of the Company Core Data Sheets applying scientific and clinical knowledge to the process. 

Manages labeling content review and approval process applying regulatory, therapeutic area and clinical knowledge to the process.

Provide oversight to other Regulatory personnel including regional leads and ROW labeling implementation leads who are responsible for developing labeling/packaging or managing labeling content and ensure consistency across product labels. .

Uses the appropriate company systems, processes, and operations for development of and changes to labeling. Assures that cross-functional labeling processes are compliant with approved company procedures and manages process improvement initiatives.

Advises cross-functional teams on labeling content consistency and best practices regarding planning and execution. Participate in identification of risk areas and develops alternative courses of action including anticipation of HA responses through scenario planning and development of contingency plans.

Effectively applies strong working knowledge of FDA, EU, Japan, and China guidance, labeling standards and medical and scientific content.

Actively supports the systems, processes, and operations for development of and changes to CCDS and key labeling, and assures compliance to those procedures.

Establishes strong working relationships with local and global stakeholders, affiliates, and business partners to assure compliant and timely implementation into business supply. Works closely with individuals/groups to influence others to facilitate consistency, efficiency, quality and compliance.

Makes and executes challenging decisions based upon sound regulatory knowledge, but also recognizes when a decision should be elevated to upper management for further consideration. Keep management apprised of critical issues which may impact the success of the organization.


Qualifcations

<Required>

Bachelor's degree.

At least 9 years previous industry experience; 6 in Regulatory Affairs in the area of labeling development.

Demonstrated expert proficiency in managing and control of pharmaceutical labeling in accordance with local and global regulatory requirements. Direct pharmaceutical labeling development experience required.

Proven proficiency with  relevant  key country  local  health  authority  regulations and guidelines for labeling development, implementation, and compliance requirements, and applies understanding to business situations.

Proven effectiveness with stakeholders in the labeling system from content development through commercial supply.

Previous experience working with US and ex-US labeling requirements, company core data sheet (CCDS) implementation and execution, and other regulatory requirements impacting or associated with labeling.

Must be able to effectively influence peers both inside and outside the organization and maintain effective working relationships.

Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously Excellent written and verbal communication skills (native and non-native English speakers).

High integrity with respect to maintenance of proprietary, confidential information.


<Preferred>

Bachelor's degree in scientific discipline; advanced degree preferred

Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development having technical complexity.

Previous experience managing direct reports



【勤務地 / Location】

・東京都中央区 アステラス製薬 日本橋事業所 本社

Nihonbashi, Tokyo


【勤務開始日 / Start Date】

応相談

Will be decided according to the candidate's flexibility


【契約期間 / Contract Duration】

期間の定めなし

Not limited to specified period


【試用期間 / Probation Period】

試用期間原則なし

No probation period in principle


【給与 / Salary】

①基本給:当人の経歴・技術・技能等を考慮して決定

②裁量労働制の場合:裁量労働手当として職務グレードに応じて50,000~100,000円支給

③フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給

①Base salary: will be decided by the candidate's experience, skill and capability.

②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000~100,000yen, based on the Grade)

③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.


【昇給 / Salary Raise】

年一回

Once a year


【賞与 / Bonus】

年2回(7月、12月)

Twice a year (July, December)


【諸手当 / Allowance】

裁量労働手当、住宅手当、通勤手当 等

Discretionary work allowance, Housing allowance, Commutation allowance, etc.


【勤務時間 / Working Hours】

8:45~17:45(月~木)、8:45~16:00(金)、裁量労働制

裁量労働制の場合、所定労働時間を働いたものとみなす

8:45~17:45(Mon~Thu)、8:45~16:00(Fri)

Flex-time system or Discretionary Work System


【休日 / Holidays

完全週休2日制、祝日、5月1日、夏季、年末年始

Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays


【休暇 / Vacation Leave

年次有給休暇、育児休業制度、介護休業制度 等

Annual paid leave, childcare leave system, nursing care leave system, etc.


【福利厚生 / Welfare

雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等

Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System


【お問い合わせ / Contact

アステラス製薬株式会社 採用担当 / Japan Recruiting team, Astellas Pharma Inc.

astellas.recruit@jp.astellas.com

※本職種についてのご質問は、上記までお問い合わせください。


"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."