Assistant Manager– Regulatory Affairs

Core Job Responsibilities:

With Manager Oversight and Supervision:

Global Labeling Portfolio:

Develops and maintains EPD Company Core Data Sheets (CCDS) and Company Core Patient Information (Master Package Leaflet) based on the available scientific knowledge, labeling guidelines and requirements within the Abbott EPD Labeling Process.  Ensures CCDS information is based on Subject Matter Expert (SME) contribution.

Organizes and participates in Labeling Sub-Team (LST) meetings, ensuring appropriate actions are followed through.

Working with Product Leads, SMEs and cross functional teams ensures appropriate documentation to support label changes (clinical overviews, Module 5 documents, Literature References, etc.) are available to complete labeling project.

With oversight, independently completes labeling activities assigned.  Assesses and approves change requests for labeling documents.  Able to participate and contribute to labeling decisions within cross-functional teams.

Supervises labeling compliance of local labeling documents and reconciles deviations with company labeling documents (e.g. CCDS, corresponding patient information).

Reviews and evaluates new labeling guidelines/policy (High surveillance countries) and determines implications for company labeling documents/labeling of therapeutic area products.

Working with Product Leads and SMEs, develops strategic labeling responses, within cross-functional team at appropriate time.

GRDS Lead/Acting GRDS Lead:

Support GRDS Leads/Be a GRDS Lead to support assigned products for all non – cmc documents required by affiliates for regulatory submissions in timely manner.

File maintenance:

Maintains accurate files of labeling change history and associated documents, using the available company electronic systems.

Promotional Material Release:

•        Reviews and approves promotional materials with respect to CCDS and are compliant. globally applicable guidance and

•        Ensures that promotional materials are accurate and compliant to internal codes of conduct, established regulations.

Affiliate Support:

Provide labeling support to affiliates including supporting renewals, geo expansions or any license maintenance activity.

Educate/guide stakeholders as and when required on labeling procedure with manager’s oversight.

Product Maintenance Activities (list is for reference and not limited):

a.      Work with RA Ops to prepare Module 2, Module 4 and 5 & have it ready for affiliate to publish.

b.      Coordination of RA information to be included in periodic reports – RMP, PSURs, ACOs (for renewals).

c.      Support renewals with clinical and pre-clinical documentation (EU and EM)

d.      Provide relevant documents for variations to EU & EM affiliates

Travel:

Up to 15% may be required

JOB SPECIFICATIONS:

Skill, Education, Experience

Minimum Education:

Bachelor’s degree in Pharmacy or life science related subject with appropriate qualification.

Diploma in Regulatory Affairs preferred

Minimum Experience / Training Required:

Ideally, 5- 7 years work experience, in the pharmaceutical industry

Previous experience in Regulatory Affairs, Global Labeling, PV, Medicines Development, Quality or related area(s)

Excellent command over spoken and written English is mandatory

Strong interpersonal skills to work with global teams is critical

Attentive to detail

Advanced word processing knowledge and experience with Microsoft Office products (Word, Excel and Power Point)

Preferred Qualifications:

Knowledge and hands-on experience with labeling texts for both health professionals and patients.

KEY COMPETENCIES REQUIREMENTS:

Managerial:

N/A

Behavioral:

Adaptability

Effectively prioritizes short-term (hours/days) work tasks.  Responds to learning opportunities.  Responds positively to changing situations.  Works with others to develop potential alternatives when confronted with problems.

Initiative

Demonstrates a willingness to learn new aspects of the business (e.g. International regulations; Clinical & CMC; Generics regulations).  Proactively seeks feedback from manager and team members and adapts behavior to improve performance.  Maintains strong customer focus.

Innovation

Identifies / tries different or unique ways (within own project / group) to address work problems or opportunities, and/or reduce costs.

Integrity

Delivers high quality results.  Meets agreed deadlines.  Exhibits honesty and presents complete impartial information.  Displays consistency between words and actions.  Acknowledges and responds constructively to failures and mistakes.  Expresses dissatisfaction constructively, without over-reacting.

Teamwork

Actively participates within team on shared goals