MEAR Product Management – Global

MEAR Product Management – Global

About Astellas:

At Astellas, experience is coupled energised with a relentless challenger spirit.

We are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up.

Relentless curiosity and a hunger for discovery flows throughout our entire organisation.

We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients.

We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.

We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.

About the job:

This position leads development, preparation and implementation of regulatory strategies to maintain, and extend product development and registrations in the INTL-GCN region, in alignment with Therapeutic Areas for maintenance activities.

Provides proactive guidance to internal groups, affiliates and/or business partners based on technical and regulatory knowledge towards development of strategic and tactical plans throughout the lifecycle of the product.

Creates and completes local regulatory documents for various submissions including, but not limited to, MAAs and their maintenance, amendments, renewals and variations, and other relevant regulatory filings.

Coordinates preparation of administrative documentation in close collaboration with affiliates and/or BP”.

Collaborates with RA TA, CMC-RA, RA operation and CCDS labeling on global/regional regulatory strategies and with Astellas functions for regional programs and products.

Provides input for RA cross functional project from region.

Actively works with project management and Regulatory Operations to ensure appropriate planning, tracking, and alignment of content and timelines for regulatory submissions across indications and compounds in the Region.

Provides updates and manages assigned regulatory submission timelines using the appropriate project management tools.

If applicable: Develops professional relationships with Business Partners staff and acts as main contact with local regulatory agencies directly in coordination with Business Partners; supports agency meeting preparation, and key agency meetings to ensure full discussion of issues and opportunities and tracks key outcomes and commitments.

Provides guidance to all appropriate departments to ensure compliance with applicable regulations.

Remains knowledgeable about current regulations and guidance, including interpretation of regulations/guidance and notification of appropriate Astellas personnel.

Develops, reviews and maintains regulatory and other company-wide and departmental policies and standard operating procedures.

If applicable: Reviews and approves promotional materials for assigned portfolios registered and promoted locally in the Sub-Region.

If applicable: Provides regulatory expertise to Drug Safety teams (e.g., PSUR and PBRER applications, Risk Minimization Plans submissions).

If applicable: Participates as member of the Sub-Regional Leadership team and other leadership committees, as appropriate, supporting and contributing to the development and sustained success of Astellas products that provide solutions that matter to the patient’s health through excellence and leadership in strategic and operational competencies.

Supports CMC-RA team in the review of product Change Control and defines an appropriate submission plan and expected approval timeline for those changes that impact the local portfolio.

If applicable: Supervises and coaches staff, including contract support and affiliates.

Interacts with peers in other regions within RA-INT to ensure alignment any synergy of strategic

Essential Knowledge & Experience:

Bachelor’s degree in scientific discipline required; advanced degree preferred.

3 years previous experience in pharmaceutical companies or equivalent.

3  years previous experience with submissions in the Sub-Region.

If applicable: Fluent in English, Spanish or other relevant languages appropriate to the sub-region.

Strong scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development.

Recognized as an expert in an aspect of pharmaceutical drug development.

Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to direct reports and others in the department as needed.

Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members.

Excellent written and oral communication skills, with writing ability to meet regulatory requirements and standards.

Ability to communicate effectively with cultural awareness and sensitivity and maintain effective working relationships.

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

Additional Information:

Full time – Permanent Global Role

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