Pharma Manager Regulatory Affairs Job @ Piramal
Pharma Manager Regulatory Affairs Piramal Pharma Vacancy Piramal Pharma. Piramal Ltd invites postgraduate and undergraduate Pharmaceutical science candidates for the post of associate. Interested and eligible candidates may apply online. Check out all the details on the same below:
Job Title: Manager Regulatory Affairs
Essential Qualifications:
- BS, B Pharm or MS degree in scientific discipline or equivalent education and 5-7 years experience in a pharmaceutical environment with at least 4 regulatory affairs experience required. Must have experience mentoring junior staff.
- Previously managerial experience preferred.
- Knowledge of global regulatory filings preferred.
- Medical Device experience a plus.
Essential Experience:
- Must effectively multi-task, establish priorities and work in a fast paced environment.
- Must demonstrate leadership skills and ability to interact with management.
- Possess excellent written and verbal communication abilities.
- Expert knowledge of the pharmaceutical business and proficiency at interpreting
- regulatory guidelines to convey regulatory options while supporting strategic business objectives.
- Must have thorough understanding of technical and scientific information to advance project goals.
Key Roles/Responsibilities:
- Interpret regulations, guidelines, and compliance requirements and communicate them to other team members and departments within the organization while demonstrating a high ability to make appropriate decisions.
- Work closely with RA management team to ensure regulatory strategies are executed and submissions are sent to Health Authorities within required timeframes
- Manage the assembly, compilation and submission of documentation for product compliance, registration and life cycle maintenance.
- Responsible for reviewing all submissions compiled by other team members prior to dissemination to Health Authorities, country distributors or external partners.
- Collaborate with cross-functional teams to ensure PCC and its partners are aware of all regulatory requirements and meet pre-defined submission timelines.
- Work with cross functional team and contract manufacturers to ensure successful and timely transfer of products to new CMO.
- Work closely and train junior regulatory staff as required.
effectively multi-task and establish priorities while working in a fast paced environment. - Work closely with internal and external manufacturing sites to support the change control process and provide timely and accurate regulatory assessments for products in applicable region(s).
- Create/revise SOPs and work instructions as necessary (including global harmonization of SOPs).
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Legal, Regulatory, Intellectual Property
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Employment Type: Full Time, Permanent
Editor’s Note: Vacancy Available, Pharmaceutical Science job opening 2019, Pharmacy jobs 2019, Pharmacy jobs 2019, Subscribe to Rasayanika for latest chemistry and Pharma job openings. Follow us on Facebook for the latest updates.
