Job Description

• Join the premier biopharmaceutical company that has been in Asia Pacific for over 60 years.
• Bring your entrepreneurial curiosity and learning spirit into a career of purpose, personal growth, and leadership.
• Your chance to be in a regional leadership role and at the centre of strategic excellence.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. The Regional Regulatory Affairs Lead is accountable for Regulatory Affairs (RA) activities within the Asia Pacific region including compliance with RA processes and regulations, policies and procedures, establishing best practices for the region, representing the company for any safety, regulatory or compliance issues at the regional level and interfacing with Global RAI therapeutic leads, labelling and business process leads, Global Medical and Scientific Affairs (GMSA) and other business units to ensure alignment on issues impacting regulatory affairs activities. What will you do: The Regional Regulatory Affairs Lead directs the activities of the Country RA Leads and teams, The Regional Liaison and Business Process teams for the Asia Pacific region. The Regulatory Affairs Lead will therefore

• Define the strategic direction of Regulatory Affairs in the region and develop short, medium and long- term action plans to fulfil the strategy. Ensure said strategy is aligned and supportive of the global and regional objectives and considers the evolving, complex and volatile regulatory environment across the region.
• Build leadership and functional capability to keep pace with the changing science and regulatory environment, as well as managing departmental resources in line with changes in portfolio volume and priorities
• Be accountable for the planning and execution of regulatory strategies for medicinal products and medical devices across all subsidiaries in the region.
• Be responsible for delivery of extensive and complex cross-divisional projects, by leading the Regulatory Affairs team to collaborate with other functions to ensure that global and regional objectives are met.
• Be recognized as a subject matter expert and driver of innovation in regulatory processes and pathways and be considered a thought leader both externally and internally, increasing company\xe2\x80\x99s credibility in the pharmaceutical sector.
• Be accountable for maintaining products on the market through timely delivery of regulatory commitments, as well as achieving approval for new products. Deliver regulatory success as a key revenue driver, both for existing and new revenues streams, thus enabling the continuous growth in the region.
• Partner with GMSA and Commercial functions to ensure compliance with registration and pharmacovigilance requirements as well as legal requirements administered by the country Health Authorities.

• The position reports to the Head of Regulatory Affairs International and is a member of the RAI Leadership Team and a member of the Asia Pacific Extended Leadership Team. As requested by the Head of RAI the incumbent may undertake additional activities. Extensive travel within the region and globally is required.

What should you have:

• The incumbent must have a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken).
• He/she must have at a minimum 10 years of industry experience in regulatory affairs, 5 or more years supervisory experience, and 5 or more years working with &/or collaborating across multiple countries within the region.
• Extensive knowledge of regulatory regulations.
• The Asia Pacific Regional Lead is expected to have strong leadership, communication, decision making, and problem-solving skills. He/she must also have experience interacting with internal auditors and health agency inspectors. Ability to travel within the region and globally is required.

Who we are \xe2\x80\xa6 We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world\'s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for \xe2\x80\xa6 Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us\xe2\x80\x94and start making your impact today. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s):
Requisition ID:R242648