Senior Regulatory Affairs Consultant II

POSITION OVERVIEW:

Syner-G BioPharma Group seeks a Manager/Senior Manager of Regulatory Affairs to provide regulatory consulting to a large, global pharmaceutical Client in the areas of Chemistry, Manufacturing, and Controls (CMC), to ensure compliance with FDA, EMA, and global regulatory requirements (with a focus on post-approval). A successful candidate will have a proven track record of applying scientific principles to solve challenges.

WORK LOCATION:

Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

• Demonstrating strong ownership, initiative and accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
• Actively contributes to strategic discussions and decision-making processes.
• Possesses excellent communication skills, exhibit strong leadership potential in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
• Contribute to the development of CMC regulatory strategies and submission documents for post approval pharmaceutical products with the ability to execute tasks independently in accordance with US, EMA & global regulations and ICH guidance.
• Execute regulatory strategies by leading the authoring and review of global CMC submissions and ancillary documentation to support post-approval supplements/variations, and responses to health authority questions using established business process and submissions tools.
• Collaborate with CLIENT and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Coordinate timely and accurate responses to the Regulatory agency questions (RTQs) on CMC content.
• Responsible for regulatory operational activities including organizing, tracking, and sending submissions for publishing for the US and other International Markets.
• Provide regulatory change control assessments and strategize post-approval implementation and applicable regulatory reporting.
• Perform regulatory reviews of technical/development documents such as certificate of analysis (CoA), analytical test methods, specifications, and stability protocol/report/data.
• Support and prepare other CMC ad-hoc requests at the pre & post-approval stage of the product.
• Author/compile documentation for regulatory submission packages including post approval submissions, information request updates, and new markets registration, source of supply changes for submission to global regulatory agencies.
• Proactively ensure all regulatory documents are prepared accurately and completed in a timely manner towards project completion.
• Maintains knowledge of current FDA, EU, global regulations and guidance’s applicable to marketed products.
• Assess and communicate potential regulatory risks and product mitigation strategies.
• Identify, communicate and escalate potential regulatory issues to concerned CMC team/management, as needed.
• May manage a team of two (2) to four (4) individual contributors in support of project execution.
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
• Potential for pre-approval submissions (IND/CTA/IMPD) authoring depending upon prior experience and expertise.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor’s or Master’s degree required in sciences, Pharmacy, Biological sciences, Engineering, or related field, Advanced degree preferred.

Experience:

• Minimum seven (7) years of CMC post approval submissions or relevant experience, which may include regulatory, research, manufacturing, analytical methods development, quality control, or related fields.
• Minimum 5 years’ experience in post approval CMC authoring and review of CMC sections in Module 1, 2, and 3 for the post-approval regulatory filings required.
• Demonstrated superior oral and written communication skills, as well as interpersonal skills; detail-oriented and well organized.
• Working knowledge of the US and European regulations and ICH guidances.
• Extensive knowledge of pharmaceutical development, specifications, release and stability of drug products and substances.
• Strong knowledge and experience of working in cGMP environment preferred.
• Hands on experience in regulatory systems and tools for authoring and change controls assessment is a plus (i.e. EDMS, Veeva Vault, Trackwise).
• Demonstrated ability to prioritize and handle multiple projects simultaneously.
• Proactive and self-motivated; ability to take initiative.
• Strong work ethic and desire to thrive in a fast-paced, deadline-driven environment.
• Prior Supervisory experience in pharmaceutical industry is a plus.

Skills and Attributes:

• Excellent written and verbal communication skills
• Strong organizational and project management abilities
• Ability to manage multiple priorities and work independently in a fast-paced environment
• Proactive, detail-oriented, and self-motivated with a strong work ethic