Senior Regulatory Affairs Specialist

Medicine) supporting the Regulatory Affairs Lead, Singapore in executing regulatory strategies and maintaining compliance to internal, external regulations and Quality Management System.

Overall purpose of job:

• Coordinates, compiles, and submits new drug applications (NDAs), product line extensions and variations to Health Authority.

• Ensure compliance to company SOPs and Quality Management System.

Essential duties and responsibilities:

• Ensure timely product registrations by internal timelines

• Prepare and maintain existing product licenses with updated CMC and CCDS changes

• Gathers and assembles information necessary for submission in accordance with regulations and relevant guidelines

• Prepare responses to regulatory agencies' questions and other correspondences, in collaboration with local and global functional teams

• Interact with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters

• Collaborate with management and internal stakeholders (e.g. Medical Affairs, Marketing) to manage product strategy, local registration and launch activities. Align filing plans and timelines with internal stakeholders including management, business partners and regional office

• Ensure adherence to standard operating procedures and protocol for the timely approval of marketed drugs

• Ensure compliance to J&J and local regulatory guidelines

• Provide ad-hoc local assessment on regulatory filings

• Provide regulatory support to other countries when required e.g. CPP application

• Manage and maintain local and global regulatory tracking systems

• Ensure post-approval commitments by the health authority are managed in a compliant manner

• Assist in the review of labeling and promotional materials

• Participate in internal and external audits

• Maintenance of the relevant company regulatory licences (e.g. Therapeutic Products' Importer & Wholesaler Licences, Controlled Drug Wholesale Licence), where applicable

• To act as the Company's Responsible Person, with the authority to hold the specific licenses required for the legal function of the business with the health authority.

• To act as Company's Controlled Substances Responsible Person.

Qualifications

Essential knowledge and skills:

• Bachelor's degree or equivalent in Pharmacy, Science or related discipline;

• Minimum 2 - 3 years of experience in regulatory affairs within the pharmaceutical industry

• Excellent verbal and written communication skills - proficiency in written and oral English is required;

• Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor;

• Proactive team player, able to take charge and follow-through;

• Proficiency with Microsoft applications such as Excel, Word, PowerPoint.

Core competencies required for this role:

• Excellent interpersonal & communication skills

• Demonstrate strong planning, organizational and decision-making skills

• Good team-player with strong collaborative mindset with cross-functional team and stakeholders

• Meticulous, strong analytical and problem-solving skills

• Results oriented with high sense of urgency

• High integrity, ethical and professional

• Independent, self-driven and change agent

• Coaching and mentoring of junior team members, where applicable