Senior Specialist/specialist, Regulatory Affairs

3 days ago


Singapore Boston Scientific Corporation Full time

**Senior Specialist/Specialist, Regulatory Affairs Support APAC (1 year contract)**:

- Remote Eligible: Hybrid- Onsite Location(s): Singapore, SG**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions.

**Purpose Statement**

The RA Support Specialist will be responsible for supporting the management of the copy approval process for advertising and promotional collateral across the APAC region. This will be accomplished by partnering with our internal and external stakeholders and working within our internal digital asset management tool to traffic & monitor projects through their workflow cycles.

**Roles and responsibilities**:

- Develop detailed knowledge of the Advertising laws and regulations across APAC markets through working closely with the specific country Regulatory and Legal teams to define what is and is not permitted across different formats (physical, digital, social media, etc.)
- Maintain current regulatory approval and product knowledge across the organization
- Enable timely and efficient review and approval of both digital & non-digital promotional materials through internal copy approval processes ensuring compliance of the business to applicable laws and regulations
- Partner with the APAC Digital Marketing team to help accelerate their ability to bring the right marketing materials to different markets
- Tracks progress of all assigned projects through internal copy approval workflow system
- Ensure timely and accurate asset uploading into internal digital asset management tool
- Manage expiring collateral utilized to ensure compliance with internal processes & procedures
- Must foster on-going partnership with cross-functional stakeholders (Global Marketing, APAC Marketing, Professional Education, Sales Learning, HEMA, RA & Legal) in order to achieve business objectives.
- Provide guidance & training support to internal stakeholders on policies and procedures pertaining to copy approval processes and the digital asset management system
- Will be responsible to manage multiple projects, both digital & non-digital, simultaneously across several stakeholder groups and countries
- Work closely with country regulatory and legal teams to learn and keep abreast on changing rules and regulations.

**Roles and responsibilities**:

- Degree in science or a related field desirable with at least 1 year of relevant experience in related industry or Diploma in related field of studies coupled with at least 3 years of experience
- Good understanding of the ISO 9001/ 13485 quality system requirements
- Demonstrated success dealing with multiple stakeholders across all levels of an organisation
- High level of communication skills both verbal and written
- Well-developed interpersonal skills and ability to engage all stakeholders
- Strong analytical skills and ability to interpret regulatory requirements to support business outcomes and compliance
- A good team player who believes in collaborative approaches
- Ability to converse in Japanese and mandarin would be an advantage due to business liaison within APAC but not a mandate

**Requisition ID**:551867

**Job Segment**:Regulatory Affairs, Compliance, Law, Advertising, Legal, Marketing



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