pSivida Corp

CAREERS

Working at pSivida Corporation

Regulatory Affairs Associate (Contractor) – Watertown, MA 40 Hours/Week

This 6-month position has the potential to extend an additional 18 months.

Scope

Seasoned Regulatory Affairs CMC Specialist with experience in assembling CMC sections required for MAA and NDA submissions

Works with manufacturing department to assemble/prepare m32P sections for MAA and NDA submissions

Ensures that regulatory documentation meets relevant regulatory requirements

Ensures regulatory compliance within the scope of responsibility

Builds cross-functional relationships and ensures communication/clarity of regulatory timelines and strategy

Responsibilities

Prepares high quality m32P documentation and assures regulatory compliance with all existing and relevant requirements

Coordinates and integrates m32P preparation activities with other members of the regulatory department

Provides regulatory advice to, and liaisons with, key pSivida colleagues

Provide accurate, consistent, timely and balanced responses on the assigned product(s) raised by the authorities and/or internal relevant stakeholders

Informs pSivida departments of existing/new regulatory requirements that specifically affects pSivida’s manufacturing activity

Regularly meets with VP, Regulatory and regulatory submissions team(s) regarding all m32P topics/issues

Establishes and maintains a m32P section preparation schedule and ensures that all team members receive updates as is appropriate

Requirements

Technical Skills:

Knowledge of drug development practice, rules, regulations and guidelines

Knowledge of EU and US requirements for m32P documentation

Knowledge of eCTD formats and requirements

Familiarity with software used to prepare eCTD sections, (e.g. Starting Point)

Familiarity with factors likely to influence the regulatory environment, including relevant new and emerging guidelines

Maintains professional networks to learn in advance about new regulatory trends or changes impacting pSivida’s MAA/NDA submissions

Communication skills

Clearly conveys information and ideas in a manner that engages colleagues and helps them understand the message

Problem solving skills

Effectively identifies issues and challenges and works with others to identify options and implement agreed upon solutions

Detailed orientation skills

Ability to be thorough and deliver high quality in the preparation of m32P sections

Ability to review/revise sections for accuracy, clarity, and consistency within a document and between documents

Behavioral Competencies

Understands stakeholder needs

Builds network and alliances within team

Influences team members by effective persuasion

Adapts and relates well with all levels of staff functions, and regulatory agencies

Has a strong quality and compliance orientation

Is perceptive and analytical

Functions well in a start-up environment

Qualifications

3-5 Years Experience as Regulatory Affairs Specialist

Previous experience preparing for commercial applications required

Proven ability to consistently deliver to time, cost and quality standards

Excellent written and spoken communication skills

EEO & Employment Eligibility

pSivida is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. pSivisa also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

 

 
 

pSivida