Regional Regulatory Affairs (Senior) Associate - APACMerck Group

Your role:
As Regional Regulatory Affairs (Senior) Associate, you are responsible for executing all regulatory submissions in the assigned Asian countries per regulatory and business requirements. You support regional/local and global strategies, plan and communicate registration plans and generate options to obtain product approvals and support product changes. You are responsible for dossier compilation to ensure ready to submit dossier is available as per respective countries requirements. You coordinate labelling compliance and support promotional material process. You ensure all regulatory activities for the assigned Asian countries and portfolio are tracked in relevant company systems according to compliant procedures. You participate in business meetings with cross-functional teams & external customers, and provide active and ongoing guidance within submission projects. You assist Global Regulatory Affairs department in the update, enhancement & creation of internal procedures. You research health authority regulations and competitor intelligence across Asia.
The position will be based in Bonifacio Global City, Taguig, Philippines.
Who you are:
Graduate of a Bachelor's Degree in Pharmacy or other Science Degree preferred, with minimum of 2-4 years of experience as a regulatory professional
Excellent English verbal and written communications skills, additional Asian language is of advantage (e.g. Mandarin, Malay, Thai ...)
Ability to interact effectively with all middle management and other functions
Effective time management skills to multi-task several initiatives with demonstrated ability to achieve success
Advanced skills with all standard MS office and business applications
Travel flexibility on occasional basis
Job Requisition ID: 206139
Location: National Capital - all
Career Level: C - Professional (1-3 years)
Working time model: full-time
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