Senior Manager, Regulatory CMC

BeiGene; Saxnäs; In loco; SEK 900.000 - 1.300.000; Tempo pieno

Vantaggi offerti da questo lavoro

Performance-based bonus

Company shares

Learning & development

Benefits program

Descrizione del lavoro

BeOne is seeking an experienced regulatory professional to manage CMC submissions for Japan, coordinating with global teams to develop strategies and timelines. You will draft, translate, and maintain CTD modules (M1.2/M2.3) in English/Japanese and support PMDA interactions.

The role requires 3+ years in pharma/biotech regulatory CMC, strong writing skills, and familiarity with ICH and GMP. The position offers competitive compensation, shares, and development opportunities in a fast-paced,

Competenze

• 3+ years of related pharmaceutical or biotech regulatory CMC experience.
• Experience in authoring complex regulatory CTD sections (M1.2/M2.3).
• Excellent written and verbal communication skills.

Mansioni

• Lead CMC regulatory submissions for Japan, coordinating with Global regulatory CMC teams.
• Develop and implement Japan-specific CMC submission strategies and timelines.
• Prepare Japan CTD M1.2/M2.3 with Global teams in English/Japanese.

Conoscenze

Regulatory CMC experience

Excellent communication

Detail-oriented

Self-motivated

Formazione

BA/BS Degree in scientific disciplines

MS/PhD preferred

Strumenti

MS Office

Veeva Vault

Descrizione del lavoro

Job Description

General Description

BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC‑related regulatory submissions to meet aggressive timelines. The individual will provide support to cross‑functional teams on CMC regulatory strategies.

Essential Functions of the Job

• Manages both small molecule and biologics products (also new modality if applicable).
• In collaboration with Global regulatory CMC teams, develop and implement Japan regulatory CMC related submission strategies and timeline; work collaboratively with cross‑functional teams and communicate Japan strategies and timeline as needed.
• Conduct regulatory risk assessment, lead to identify key regulatory CMC issues and mitigation activities on Japan regulatory submissions.
• At CTN stage, receive CMC information from Global regulatory CMC teams and lead the gap analysis per Japan specific CMC requirements. Prepare Japan regulatory CMC related documents.
• At NDA/BLA and regulatory maintenance stage, receive core dossier from Global regulatory CMC teams and lead the gap analysis per Japan specific CMC requirements. Prepare Japan CTD M1.2/M2.3 with Global regulatory CMC teams in English/Japanese based on M3 from Global RA CMC team.
• Lead to complete local Japan regulatory CMC related forms, proof‑reading the translation of the dossier and Health Authority questions, and interpret Health Authority questions.
• Provide change control impact assessment on Japan submissions, guide/evaluate judge "PCA" or "MCN" with Global regulatory CMC teams.
• Manage manufacturing license including foreign manufacturer accreditation (FMA) for Japan products.
• Support Reg CMC interaction with PMDA and supports inspection.
• Support the development of Japan CMC dossier template for both CTN and NDA/BLA and contribute to Reg CMC country specific requirement database on Japan requirements.
• Support regulatory CMC operational excellence including process establishment or/and optimization.
• Support commenting on new/updated Japan CMC related regulatory guidance/regulation through company’s commenting process as needed.
• Ensures proper CMC regulatory assessments and actions are taken when recalls or product complaints arise during product lifecycle for the assigned project in the Japan market.

Supervisory Responsibilities

The position may manage direct report(s) in the future.

Qualifications

Education Required

BA/BS Degree in scientific disciplines; MS/PhD preferred.

Computer Skills

• Strong PC literacy is required; MS Office skills (Outlook, Word, Excel, PowerPoint).
• Familiar with Veeva Vault system is plus.
• Familiar with Japan regulatory system is plus; FD system, Open Trusty/Open Approval system, Gateway system.

Other Qualifications

• 3+ years of related pharmaceutical or biotech regulatory CMC experience with proven record of experience in market applications and subsequent response to HA (MHLW/PMDA) queries.
• Experience in authoring complex technical documents and regulatory CTD (M1.2 and M2.3) sections.
• Knowledge of ICH requirements, USP/EP/JP regulatory and requirements.
• Knowledge/experience with GMP regulation and post‑approval submissions is a plus.
• Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc).
• Excellent oral and written communications skills are a must‑have.
• The candidate should be detail‑oriented, a self‑motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast‑paced environment.

Travel

• As needed.

What We Offer

• Market competitive compensation package including performance‑based annual bonus scheme.
• Company shares (generous welcome grant!).
• In‑house and external learning and development opportunities.
• Fantastic benefits program and keep improving.
• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
• Join us and make momentum in your career.