Regulatory Affairs Associate Manager

JOB MAIN PURPOSE

YOUR ROLE & RESPONSIBILITIES

• Coordinate with Global RA partners to execute routine registration activities for portfolio assigned (including new registration, renewal and variations) such as:
  • timely request registration dossier and other necessary documents where needed
  • prepare registration dossiers
  • ensure regulatory compliance for life cycle management including evaluation and implementation of manufacturing and labelling changes in accordance with local regulations and relevant Bayer SOPs
  • involve in relevant regional/global meetings and cross‑functional meetings related to project when required.
• Coordinate with CQH to manage product complaints and recall process, including health authority interaction and communications. Provide necessary documents to enable CQH to complete local compliance checks.
• Responsible in maintenance of a local quality system including archiving, contact reporting, maintenance of regulatory tracking database and tracking of documents submitted for assigned products.
• Liaises closely with MOH, local industry and other regulatory agencies to establish and maintain effective communication with them.
• Monitor regulatory environment and competitor regulatory activities for portfolio assigned. Assess impact and timely communicate to internal stakeholders. Works on mitigation plan to optimize submission strategies and maximize business benefit.
• Takes responsibility in reviewing promotional materials that are relevant to assigned therapeutic area when requested by material’s owner.
• Support tender by update EU/PIC GMP listing, original product list and provide other necessary RA related documents.

VALUE ADDED TO THE SUCCESS OF THE COMPANY

• Responsible for Regulatory submissions and approvals for products assigned, enabling the achievement of business strategic objectives as well as for ensuring regulatory compliance. Priority setting and flexibility are constantly needed.
• Provides input and insights for regulatory probability assessments, anticipating these changes based on experience and knowledge of the environment.
• Building relationships with the Health Authorities, as key customers, is essential for achieving business goals. The relationship is based on trust, transparency and partnership and is clearly a major focus of this function.
• Maintain compliance with all relevant regulatory requirements with no supply disruption due to lack of regulatory oversight.
• Maintain system for archiving regulatory documentation with easy access to regulatory history and regulatory documents.
• Secure and maintain compliant product licenses, product labelling and participate in promotional material review/approval for a product range.
• Provide timely, high‑quality support, incl. regulatory information to the relevant local functions and regulatory team.

YOUR KEY SKILLS & QUALIFICATIONS

• Have medical or pharmaceutical background with a minimum of 3‑5 years pharmaceutical industry experience in regulatory affairs.
• Have capability to work independently and cross functionally.
• Have good communication skills.
• Fluent in English and ability to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills.
• Ability to focus on multiple issues at one time, ability to organize, prioritize and direct diverse activities in a changing environment often under time pressure.
• Solid and demonstrated knowledge of all compliance aspects related to the regulatory affairs function.
• Thorough knowledge of company policies and procedures. Detailed understanding of the process and policies of the national or agency or extensive experience with a related national health authority.
• Profound knowledge of local regulations and applicable legislation including regulatory requirements and regulatory framework related to registrations and post‑approval variations.
• Meticulous.
• Good time management skills.

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