Clinical Regulatory Affairs, Parexel Consulting (Sr Associate to VP)
Waltham, MA 
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Posted 3 months ago
Job Description

Join Parexel Consulting and partner with our clients to bring new therapies to the patients.
We currently have multiple openings for experienced Clinical Regulatory Affairs professionals from junior to senior levels, and opportunities to partner with small to mid-sized clients who have robust pipelines and amazing products in various stages development!

Our Regulatory Consultants use their expertise to partner with our clients in a variety of ways from developing clinical regulatory strategies; conducting gap analysis; preparing and/reviewing clinical sections of INDs, BLAs, and NDAs; leading innovative programs; to attending FDA and other Health Authority meetings!

As a Sr Associate, you will:
* Support Product Development Regulatory Affairs Program Manager in his/ her responsibilities and assist the Product Development RA Program Manager to accomplish his/her tasks in meeting deadlines to achieve the projects, teams and departmental goals
* Prepare regulatory submissions in collaboration with the other disciplines in Product Development Research
* Establishes effective working relationships internally and externally with regulatory authorities.
* Documents meetings, teleconferences and other interactions/communications with regulatory authorities.
* Additional regulatory- and project-related support activities/services as requested by the client project lead(s)/team(s).
* Ensures compliance with SOPs and national regulations.

As a Senior Consultant, you will:
* Provide senior level, experienced regulatory leadership to satisfy expected industry standards, applying in-depth knowledge of client specific and regulatory requirements and guidelines, procedures and best practices, including compliance.
* For assigned project(s), as requested and monitored by the client's project lead(s)/team(s), act as an accountable agent on behalf of the client to the U.S. Food and Drug Administration (FDA) and via client's affiliates as applicable to work with ex-US Health Authorities - and lead and support regulatory team (cross sub functions of regulatory including documentation, CMC, submissions, labeling) or equivalent members for related activities.
* Provide experienced stakeholder management interfacing directly with internal stakeholders of various levels.
* Additional regulatory- and project-related support activities/Services as requested by the client project lead(s)/team(s).

As a Principal Consultant or Vice President Technical, you will:
* Provide expertise, solutions, and strategy to various clients on exciting products in various stages of development. You will work alongside a distinguished team of Subject Matter Experts who have a wealth of Industry and FDA experience, along with a wide variety of Technical Expertise!
* A Principal Consultant or VP, Tech within the Parexel Consulting Organization must be a nationally recognized professional in their field of expertise with well-developed and proven rainmaking skills. Must have a comprehensive understanding of the organization's consulting models and methodologies, as well as, an extensive knowledge of what services PC provides. Provides a full range of consulting services and works within their personal area of expertise. Provides mentoring and guidance to junior team members on technical and/or business issues and supports knowledge-centered activities within PC.

Qualifications
To ensure success:

As a Sr Associate, you will have:
* Previous experience in a clinical regulatory affairs focused role in industry.
* Graduate (Bachelors) Degree required (life sciences disciplines strongly preferred)
* Average of 3 or more years' relevant clinical experience in regulatory affairs (US, EU, ROW); including extensive knowledge of clinical drug development, submission requirements and Health Authority interactions.
* Knowledge of GxP, ICH, and other regulatory guidelines.
* Knowledge of the drug development process and how other functions contribute.
* Fully competent in teamwork/collaboration, achieving results, regulatory knowledge, operational excellence and organized.
* Previous respiratory, neuroscience, anti-effectives and oncology is preferred; however, exceptional candidates with other TA experience will also be considered.
* Strong regulatory program management, leadership, teamwork, and communication skills.
* Strong verbal and writing skills; proficient in MS Office apps.
* Past experience supporting IND/NDA/BLA maintenance, supporting filings (INDs, BLAs, NDAs), supporting FDA meetings, supporting post marketing activities, representing regulatory at study team meetings, and coordinating answers to regulatory questions

As a Senior Consultant**, you will have:
* Previous experience in a Clinical Regulatory Affairs role in industry
* Bachelors Degree required (life sciences disciplines strongly preferred)
* Advanced Degree in a related field is strongly preferred
* Average of 10+ years' relevant clinical experience in regulatory affairs (US, EU, ROW); including extensive knowledge of clinical drug development, submission requirements and Health Authority interactions. **Qualified candidates with an average of 5-7 years' relevant clinical regulatory affairs experience will be considered at the Consultant level.
* Knowledge and deep experience of the drug development process from IND/CTA opening through final product approval, and how other functions contribute to a regulatory submission (IND/CTA/IMPD, NDA/BLA/ANDA/MAA, etc.)
* Knowledge of GxP, ICH, and other regulatory guidelines; experience in providing regulatory assessments and guidance including considering precedence and relevant HA guidance through many project-level activities
* Fully competent in strategic agility, communication (stakeholder management), leadership, pharma drug development, organizational and business knowledge
* Previous respiratory, neuroscience, anti-effectives and oncology experience is preferred; however, exceptional candidates with other TA experience will be considered
* Experience in regulatory affairs (US, EU, ROW); experienced in submission requirements and HA interactions
* Strong regulatory program management, leadership, teamwork, and communication skills

As a Principal Consultant or Vice President Technical, you will have
At least 15+ years' experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design and authoring clinical sections of regulatory applications. Previous experience with a regulatory agency (such as the FDA or MHRA) as a Medical Review Officer, Team Lead, Branch Chief or a related Medical role ie. Clinical Pharmacology Review is a plus; however, candidates with strong industry backgrounds and experience driving strategy and leading clinical development programs will also be considered.

All roles require the ability to travel up to 30% and Senior Consultants, Principal Consultants, and VP Techs may travel both internationally and domestically as needed.

EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
3+ years
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