Senior Regulatory Affairs Manager

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Job Description

Job Title:  Senior Regulatory Affairs Manager

Location:  Makati, Philippines

About the role:

The job requires the person to manage Regulatory Affairs for all Company products to ensure they are in compliance with statutory and company requirements and maximize the contribution of Regulatory Affairs to the achievement of business objectives through active assistance in the development and implementation of the company’s policy positions and product advocacy strategies.

How you will contribute:

• Plan, strategize and monitor regulatory filings for timely submissions and approvals of new product registrations and variation applications.
• Manage Life cycle maintenance of existing product portfolio while ensuring smooth supply of products
• Manage labeling changes, safety updates, artwork development and artwork approval of packaging material components.
• Provide leadership of all quality related activities in the Philippines, including developing and implementing regulatory strategy and life-cycle management of Takeda's products.
• Ensure effective communication with business partners and representatives of the local regulatory/health bodies.
• Lead the regulatory team, build skills and capabilities to support continual business growth and performance while representing the LOC on regional/ global and external forums
• Collaborate with Public Affairs team to help shape public policies
• Shape regulatory reforms to increase access to innovative medicines and vaccines in PH
• Address regulatory challenges for in-line and pipeline products
• Proactively be involved in policy development and related engagements necessary to raise importance of regulatory reforms

Regulatory Affairs

• Registered Pharmacist for Philippines LOC
• Build effective working relations with the regulatory agency and follow-up closely on approval of products registration and variations
• Work with all appropriate local functions to develop and implement the best regulatory strategies/plans to support commercial goals and product launch excellence.
• Review promotional material in relation to product campaign launches and ongoing product marketing activities.
• Support regulatory review or artwork/promo material/ad-hoc requests for all products
• Update and maintain local and global-associated databases with Philippines regulatory information
• Keep track of policy changes, current and emerging issues, understand their potential impact on business and build corresponding strategies to support business
• Develop and maintain good and effective relations with Philippines FDA and pharmaceutical associations
• Participate in local authority inspections and internal audits when applicable to the regulatory affairs function.
• Develop annual regulatory budget for Philippines filings/variations/registrations/license renewals and department needs.

What you bring to Takeda:

Education and Experience Requirements

• Bachelor’s degree in Pharmacy.
• Pharmacy professional license holder.
• A minimum of 10 years of relevant Regulatory Affairs expertise in the pharmaceutical industry.
• Experience in registering and launching Vaccines markets is preferred.

Key Skills, Abilities, and Competencies

• Strong communicator with the ability to engage both external and internal customers.
• Able to build a collaborative network of relationships with people in a variety of functions, roles and locations and leverages formal and informal networks to accomplish the ambitious goals.
• Strong ability to assimilate information (technical, clinical, medical, scientific) quickly, present clinical data clearly and concisely and discuss the statistical and clinical relevance in line with key messages.
• Project management skills – to deliver within set time frames.

Complexity and Problem Solving

• A good reputation in the industry with an established network within the Regulatory Affairs community.
• Experience in leading regulatory due diligence from a local perspective for business development projects
• A mind-set of continuous improvement, innovation and be solution-focused with strong problem-solving ability
• Excellent negotiation, project management, verbal and written communication skills
• Have in-depth knowledge of local regulations pertaining to regulatory requirements for pharmaceuticals, biotech, vaccines and medical devices.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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