Senior Manager - Regulatory Affairs, Latin America

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. 

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:

This role will handle all regulatory submissions related to Xtandi capsules and tablets in the entire LATAM region. This position leads the strategic planning and execution of regulatory activities for development, registration and post-authorization initiatives/submissions in Latin America. Specific responsibilities include leading/coordinating the generation and completion of regulatory documents for submissions to Latin-American health authorities and support of marketing application submissions through our affiliates of Business Partners.

Develops professional relationships with Business Partners and health authority staff whenever applicable; supports agency meeting preparation and facilitates key agency meetings to ensure full discussion of issues and opportunities; tracks key outcomes and commitments.

Acts as main contact with Business Partners in processes involving GMP certification; supports agency meeting preparations.

Essential Job Responsibilities:

• Leads the development, preparation and implementation of regulatory strategies to obtain, maintain and extend product development and registrations in Latin America. Provides proactive guidance to internal groups and business partners based on technical and regulatory knowledge towards development of strategic and tactical plans.

• 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. Directs business partners and/or manages preparation of forms, cover letters or other administrative components for

• 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 for Latin America. Provides updates and manages assigned regulatory submission timelines using the appropriate project management tools.

• 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.

• Leads the process of development, preparation and implementation of the local prescribing information.

• Reviews and approves promotional materials for assigned portfolios registered and promoted locally in Latin America.

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

• Participates as member of RALA (Regulatory Affairs Latin America) Executive Committee 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 patients health through excellence and leadership in strategic and operational competencies.

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

• Supervises and coaches staff, including contract support, of local RA department.

Organizational Context:

This position reports to APUS Executive Director, Regulatory Affairs - Latin America. This role will interact with several stakeholders, such as CMC-RA, Labeling, QA, PV, PPM, Medical Affairs, Legal to name some. This role is the main point of contact between Astellas LATAM and the Business Partners and affiliates in the region.

Qualifications:

Required

• Bachelors degree in scientific discipline required; advanced degree preferred.

• 5 years previous experience in pharmaceutical companies or equivalent.

• 5 years previous experience with submissions in Latin America.

• Fluent in Spanish and proficient in English.

• 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.

Preferred

• Experience working in LATAM countries.

• Previous experience in Multinational companies.

• Excellent Spanish and English skills.

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 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

Category Regulatory Affairs

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans