Regional Regulatory Affairs Manager for APACMerck Group

Your role: As Regional Regulatory Affairs Manager for APAC, you oversee and coordinate day-to-day operations for the country cluster. You lead, build and manage a professional team in the Regulatory Affairs Regional Hub for the products & countries under your responsibility. You coach & direct the team to produce excellent work, and provide development opportunities for team to reach their full potential. You develop regulatory product plans based on global/regional/local business strategy. You ensure plan alignment cross-functionally. You provide regulatory support and insights for country/commercial strategies and initiatives. You plan, manage, review & finalize submission with follow-up until final approval. You provide support for specific local M1 requirements & manage country input and fee planning. You communicate with partners & key local stakeholder functions including agents. You plan, prepare & conduct local Health Authority interactions. You maintain close communication & alignment with Health Authorities & other agencies, as applicable. You represent Merck & prepare communication to industry associations, as applicable. You drive regional intelligence. You cross-functionally coordinate crisis management such as stock-outs and maintain Health Authority interactions. You provide relevant support for clinical trials, as applicable.
The position will be based in Bonifacio Global City, Taguig, Philippines.
Who you are:
Graduate of a Bachelor's or Master's Degree in pharmaceutical science or an equivalent qualification with relevant work experiences
5-8 years of experience in the regulatory affairs field for the Philippines and preferably other Asian countries
At least first line managerial experience of a team of 2 or more members is required
Ability of communication and collaboration with internal and external stakeholders
High proficiency in English is a must, additional Asian language capabilities welcome (e.g. Malay, Mandarin, Thai....)
Be flexible to travel on occasional basis
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at
Job Requisition ID: 210684
Location: National Capital - all
Career Level: D - Professional (4-9 years)
Working time model: full-time
Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone's health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.
US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
Merck Group

Taguig City, Metro Manila
Permanent
Full-time