SENIOR REGULATORY AFFAIRS SPECIALIST

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.
.
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.
.
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.
.
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