Regulatory Affairs Manager

Responsibilities

• Work closely with global and local colleagues to advise and agree on regulatory strategy, clinical development plans, marketing plan as well as data requirements.
• Manage regulatory submissions process and ensure compliance with regulations; prepare high‑quality submission packages and responses for clinical trials, new product license applications, variations, and annual updates within applicable timelines.
• Monitor and influence assessment processes to expedite and optimise submission outcomes, ensuring they meet accepted regulatory standards and appropriate timeframes.
• Lead, maintain, and develop communication with regulatory authorities and consultants; drive negotiations to secure optimal product labeling and meet commitments and deadlines.
• Proactively build relationships externally and internally; work swiftly with cross‑functional teams to address critical issues.
• Communicate any regulatory changes to the business as necessary.
• Create, submit, and maintain official local drug information, including patient information leaflets and packaging texts.
• Ensure promotional activities comply with relevant legislation; implement and maintain systems for Regulatory Affairs Document Management.
• Participate in safety reviews to implement appropriate safety updates and lead audit activities for the regulatory function as required.
• Perform other job‑related tasks as assigned.

Minimum Education

A Bachelor’s degree or above in pharmacy, biology, chemistry, pharmacology or related life sciences is required.

Minimum Experience

• At least 6 years of industry experience in Regulatory, R&D, or a related area.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs (preferred).
• Experience interfacing with government regulatory agencies and proven ability to develop and implement successful China regulatory strategies.
• Experience in women’s health, cardiovascular, vaccine, etc. is a plus.

Language Skills

Fluent English, both oral and written.

Mobility

May require travel.

Other Requirements

• Experience working in a complex, matrixed environment.
• Broad range of regulatory work in the ethical pharmaceutical industry.
• Management experience.
• Up‑to‑date knowledge of legislation.