Senior Regulatory Affaist Specialist

Job purpose

• Products registration and the life cycle management of existing products (labelling update and maintenance of the product licenses) with timeline set-up.

• Short- & long-term registration planning for NCE, LE and new indications including bridging strategy

• Management of other regulatory issues

Key Resposibilities

• Planning the best-case scenarios of RA plans for Line Extensions and New indications and sharing the RA strategy with stakeholders through NPI or Launch Excellence Mtg.

• Establishment of short- & long-term detailed registration plan and follow up to meet the expected approval timeline.

• Maintenance of good relationship with regulatory authority and internal stakeholders.

• Timely and appropriate regulatory update of existing products (shelf-life extension, CMC variation, site transfer, GDS update and renewal etc.)

• Management of the existing products (safety issues handling, 3rd party support, TTS update, Registration of Drug ID Mark etc.)

• Communication and cooperation with GRA for regulatory requirements.

• Impact analysis and establishment of strategy according to the amendment of the guidelines.

Requirements

• Bachelor’s degree in pharmacy.

• Minimum 6+ years of experience in regulatory including the leadership and delivery of a range of regulatory submissions.

• Knowledge of regulatory agency guidelines and expectations in the submission process.

• Experience in the regulatory agency review process.

• Proficient English communication to effectively communicate with global and regional colleagues.

*LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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